Scolaris Content Display Scolaris Content Display

Pemberian cecair dan makanan lebih awal berbanding dengan lewat untuk mengurangkan komplikasi selepas pembedahan abdominal ginekologikal major

Contraer todo Desplegar todo

Referencias

References to studies included in this review

Amatyakul 2001 {unpublished data only}

Amatyakul P, Suprasert P. Length of hospital stay after major gynecologic operation: a comparison between traditional and early oral feeding. Dissertation thesis for the diploma in Obstetrics and Gynecology, The Royal Thai College of Obstetricians and Gynecologists2001.

Minig 2009a {published data only}

Minig L, Biffi R, Zanagnolo V, Attanasio A, Beltrami C, Bocciolone L, et al. Early oral versus "traditional" postoperative feeding in gynecologic oncology patients undergoing intestinal resection: a randomized controlled trial. Annals of Surgical Oncology 2009;16(6):1660‐8.

Minig 2009b {published data only}

Minig L, Biffi R, Zanagnolo V, Attanasio A, Beltrami C, Bocciolone L, et al. Reduction of postoperative complication rate with the use of early oral feeding in gynecologic oncologic patients undergoing a major surgery: a randomized controlled trial. Annals of Surgical Oncology 2009;16(11):3101‐10.

Pearl 1998 {published data only}

Pearl ML, Valea FA, Fischer M, Mahler L, Chalas E. A randomized controlled trial of early postoperative feeding in gynecologic oncology patients undergoing intra‐abdominal surgery. Obstetrics and Gynecology 1998;92(1):94‐7.

Steed 2002 {published data only}

Steed HL, Capstick V, Flood C, Schepansky A, Schulz J, Mayes DC. A randomized controlled trial of early versus "traditional" postoperative oral intake after major abdominal gynecologic surgery. American Journal of Obstetrics and Gynecology 2002;186(5):861‐5.

References to studies excluded from this review

Cutillo 1999 {published data only}

Cutillo G, Maneschi F, Franchi M, Giannice R, Scambia G, Benedetti‐Panici P. Early feeding compared with nasogastric decompression after major oncologic gynecologic surgery: a randomized study. Obstetrics and Gynecology 1999;93(1):41‐5.

Delaney 2005 {published data only}

Delaney C, Weese J, Hyman N, Bauer J, Techner L, Gabriel K, Du W, Schmidt W, Wallin B. Phase III trial of alvimopan, a novel, peripherally acting, Mu opioid antagonist, for postoperative ileus after major abdominal surgery. Diseases of the Colon and Rectum 2005;48(6):1114‐29.

Fanning 1999 {published data only}

Fanning J, Yu‐Brekke S. Prospective trial of aggressive postoperative bowel stimulation following radical hysterectomy. Gynecologic Oncology 1999;73(3):412‐4.

Fanning 2011 {published data only}

Fanning J, Hojat R. Safety and efficacy of immediate postoperative feeding and bowel stimulation to prevent ileus after major gynecologic surgical procedures. Journal of the American Osteopathic Association 2011;111(8):469‐72.

Feng 2008 {published data only}

Feng S, Chen L, Wang G, Chen A, Qiu Y. Early oral intake after intra‐abdominal gynecological oncology surgery. Cancer Nursing 2008;31(3):209‐13.

Finan 1995 {published data only}

Finan M, Barton D, Fiorica J, Hoffman M, Roberts W, Gleeson N, et al. Ileus following gynecologic surgery: management with water‐soluble hyperosmolar radiocontrast material. Southern Medical Journal 1995;88(5):539‐42.

Griffenberg 1997 {published data only}

Griffenberg L, Morris M, Atkinson N, Levenback C. The effect of dietary fiber on bowel function following radical hysterectomy: a randomized trial. Gynecologic Oncology 1997;66(3):417‐24.

Kraus 2000 {published data only}

Kraus K, Fanning J. Prospective trial of early feeding and bowel stimulation after radical hysterectomy. American Journal of Obstetrics and Gynecology 2000;182(5):996‐8.

MacMillan 2000 {published data only}

MacMillan SL, Kammerer‐Doak D, Rogers RG, Parker KM. Early feeding and the incidence of gastrointestinal symptoms after major gynecologic surgery. Obstetrics and Gynecology 2000;96(4):604‐8.

Pearl 2002 {published data only}

Pearl ML, Frandina M, Mahler L, Valea FA, DiSilvestro PA, Chalas E. A randomized controlled trial of a regular diet as the first meal in gynecologic oncology patients undergoing intraabdominal surgery. Obstetrics and Gynecology 2002;100(2):230‐4.

Schilder 1997 {published data only}

Schilder JM, Hurteau JA, Look KY, Moore DH, Raff G, Stehman FB, et al. A prospective controlled trial of early postoperative oral intake following major abdominal gynecologic surgery. Gynecologic Oncology 1997;67(3):235‐40.

Taguchi 2001 {published data only}

Taguchi A, Sharma N, Saleem R, Sessler D, Carpenter R, Seyedsadr M, et al. Selective postoperative inhibition of gastrointestinal opioid receptors. New England Journal of Medicine 2001;345(13):935‐40.

Terzioglu 2013 {published data only}

Terzioglu F, Şimsek S, Karaca K, Sariince N, Altunsoy P, Salman MC. Multimodal interventions (chewing gum, early oral hydration and early mobilisation) on the intestinal motility following abdominal gynaecologic surgery. Journal of Clinical Nursing 2013;22(13‐14):1917‐25.

Bufo 1994

Bufo AJ, Feldman S, Daniels GA, Lieberman RC. Early postoperative feeding. Dis Colon Rectum 1994;37:1260‐5.

Deitch 1991

Deitch EA, Andrassy RJ, Booth FVM, Moore FA. Current concepts in postoperative feeding. Contemporary Surgery 1991;39:37‐55.

Fanning 2001

Fanning J, Andrews S. Early postoperative feeding after major gynecologic surgery: evidence‐based scientific medicine. American Journal of Obstetrics and Gynecology 2001;185(1):1‐4.

Higgins 2003

Higgins JPT, Thompson SG, Deeks JJ, Altman DG. Measuring inconsistency in meta‐analyses. BMJ 2003;327(7414):557‐60.

Higgins 2011

Higgins JPT, Altman DG, Sterne JAC. Chapter 8: Assessing risk of bias in included studies. In: Higgins JPT, Green S (editors). Cochrane Handbook for Systematic Reviews of Interventions Version 5.1.0 [updated March 2011]. The Cochrane Collaboration, 2011. Available from www.cochrane‐handbook.org.

Kelly 1997

Kelly DG, Stanhope CR. Postoperative enteral feeding: myth or fact?. Gynecol Oncol 1997;67:233‐4.

Lewis 2001

Lewis SJ, Egger M, Sylvester PA, Thomas S. Early enteral feeding versus "nil by mouth" after gastrointestinal surgery: systematic review and meta‐analysis of controlled trials. BMJ 2001;323(7316):773‐6.

Mangesi 2002

Mangesi L, Hofmeyr GJ. Early compared with delayed oral fluids and food after caesarean section (Cochrane Review). Cochrane Database of Systematic Reviews 2002, Issue 3. [DOI: 10.1002/14651858.CD003516]

Nachlas 1972

Nachlas MM, Younis MT, Roda CP, Wityk JJ. Gastrointestinal motility studies as a guide to postoperative management. Annals of Surgery 1972;175(4):510‐22.

Reissman 1995

Reissman P, Teoh TA, Cohen SM, Weiss EG, Nogueras JJ, Wexner SD. Is early oral feeding safe after elective colorectal surgery?. Annals of Surgery 1995;222(1):73‐7.

Singh 1998

Singh G, Ram RP, Khanna SK. Early postoperative enteral feeding in patients with nontraumatic intestinal perforation and peritonitis. Journal of the American College of Surgeons 1998;187(2):142‐6.

Wells 1964

Wells C, Tinckler LF, Rawlinson K, Jones H, Saunders J. Post‐operative gastrointestinal motility. Lancet 1964;I(7323):4‐10.

Wilson 1975

Wilson JP. Post‐operative motility of the large intestine in man. Gut 1975;16(9):689‐92.

Windsor 1988

Windsor JA, Knight GS, Hill GL. Wound healing response in surgical patients: recent food intake is more important than nutritional status. British Journal of Surgery 1988;75(2):135‐7.

Woods 1978

Woods JH, Erickson LW, Condon RE, Schulte WJ, Sillin LE. Post‐operative ileus. A colonic problem?. Surgery 1978;84(4):527‐33.

References to other published versions of this review

Charoenkwan 2003

Charoenkwan K, Phillipson G, Tongsong T. Cochrane Database of Systematic Reviews 2003, Issue 4. [DOI: 10.1002/14651858.CD004508]

Charoenkwan 2007

Charoenkwan K, Phillipson G, Vutyavanich T. Early versus delayed oral fluids and food for reducing complications after major abdominal gynaecologic surgery. Cochrane Database of Systematic Reviews 2007, Issue 4. [DOI: 10.1002/14651858.CD004508.pub3]

Characteristics of studies

Characteristics of included studies [ordered by study ID]

Amatyakul 2001

Methods

A prospective randomised controlled study in a single institution. Participants were randomised by using consecutively‐numbered, sealed, opaque envelopes according to the list generated from a random number table. Power calculation was performed a priori.
Number of participants randomised: 106
Number of participants analysed: 106 (53 in the early group, 53 in the delayed feeding group)
Analysis: Full intention‐to‐treat analysis

Participants

Inclusion criteria: Women scheduled for major abdominal gynaecologic surgery; mean age: 40.8 years (early group), 41.1 years (delayed feeding group)
No significant difference in baseline characteristics between the two groups including age, weight, prior abdominal surgery, procedure, type of anaesthesia, operative time, estimated blood loss, and need for blood transfusion.
Location: Chiang Mai University hospital, Chiang Mai, Thailand
Enrolment period: September 1998 to January 1999
Exclusion criteria: Pregnancy, postoperative intensive care unit admission, endotracheal or nasogastric intubations in the immediate postoperative period, coincidental bowel surgery (excluding appendectomy), history of gastrointestinal diseases or gastrointestinal surgery (excluding appendectomy), history of pelvic or abdominal radiation, preoperative diagnosis of bowel obstruction or preoperative vomiting, preoperative bowel preparation, and history of peritonitis

Interventions

Early group: Participants were allowed to have sips of water within 8 hours after surgery. They were started on a soft diet in the morning of the 1st postoperative day and proceeded to a regular solid diet on the 2nd postoperative day
Delayed feeding group: Participants received nothing by mouth until at least 2 of the following signs of return of bowel function were present: 1) presence of bowel sounds; 2) passage of stool or flatus; 3) subjective hunger, in the morning of the first postoperative day. They were then allowed to have sips of water, and advanced to a liquid diet in the evening of the same day. Participants were given a soft diet in the morning of the 2nd postoperative day and were started on a regular solid diet on the 3rd postoperative day.

Discharge criteria included the tolerance of a solid diet, passing flatus, and the discontinuance of intravenous fluids and medications. Participants were not required to have had a bowel movement.

Outcomes

Hospital stay

Gastrointestinal information
Morbidity (vomiting, abdominal distention)
Postoperative intervals (presence of bowel sounds, passage of flatus, passage of stool, start of regular diet)

Notes

Funding source: self‐funded

Conflicts of interest: none

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Quote: "Patients were randomised by using consecutively numbered, sealed, opaque envelopes according to the list generated from a random number table."

Comment: Random number table

Allocation concealment (selection bias)

Low risk

Quote: "Patients were randomised by using consecutively numbered, sealed, opaque envelopes according to the list generated from a random number table."

Comment: Sequentially numbered, opaque, sealed envelopes

Blinding of participants and personnel (performance bias)
All outcomes

High risk

Comment: Because of the study's context, the participants could not be blinded. The physicians taking care of the participants were aware of their study allocation (information from the study's author). It is possible that some outcomes (hospital stay and subjective intestinal morbidities) were influenced by the lack of blinding.

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

Comment: The outcome assessors were aware of participants' study allocation (information from the study's author). However, the influence of the lack of blinding to study outcomes was unclear.

Incomplete outcome data (attrition bias)
All outcomes

Low risk

There were no missing outcome data.

Selective reporting (reporting bias)

Unclear risk

The study protocol was not published in a protocol registry. However, the report included expected outcomes.

Minig 2009a

Methods

A prospective randomised controlled study in a single institution. Power calculation was performed a priori.
Number of participants randomised: 51 (27 in the early group, 24 in the delayed feeding group)
Number of participants analysed: 40 (18 in the early group, 22 in the delayed feeding group),
Analysis: Available case analysis

Participants

Inclusion criteria: Gynecologic oncology patients aged 18 ‐ 75 years, undergoing laparotomy with associated intestinal resection; median age: 54 years (early group), 58 years (delayed feeding group). No significant difference in patient characteristics and surgical variables between the two groups except for a higher estimated blood loss in the delayed feeding group (median 800 ml vs. 300 ml).
Location: European Institute of Oncology (IEO), Milan, Italy
Enrolment period: January 1, 2007 to March 15, 2008
Exclusion criteria: Preoperative (infections, intestinal obstruction, severe malnutrition, American Society of Anesthesiologists score > 4), intraoperative (total or anterior pelvic exenteration, surgery without bowel resection), postoperative (admission to the intensive care unit for > 24 hours, final histopathologic diagnosis revealing nongynaecologic disease)

Interventions

Early group: Participants were offered liquids, mineral water (no gas), tea, chamomile infusion, or apple juice during the first 24 hours. If no nausea and vomiting, a regular diet of boiled or grilled beef, chicken, or fish was given starting on day 1 and continued for the entire hospital stay
Delayed feeding group: Participants received nothing by mouth until the presence of bowel sound and the passage of flatus. Then, if no nausea and vomiting, an oral liquid diet was given for 24 hours. If well tolerated, a semisolid diet was given for 1 day before proceeding to regular diet
Discharge criteria included the tolerance of a regular diet for at least 24 hours with recovery of bowel function, normal clinical parameters and physical examination

All participants underwent bowel preparation and preoperative antibiotics prophylaxis. In addition, a nasogastric tube was placed in all participants during surgery and was removed after the surgery finished. Postoperative analgesia was given via epidural catheter for 3 days (ropivacaine and fentanyl) or as intravascular continuous administration of ketorolac and tramadol in those without an epidural catheter.

Outcomes

Hospital stay

Recovery of bowel activity (time to first passage of gas and stool, time to tolerance of a solid diet)
Intestinal morbidities (presence of ileus, intensity of abdominal pain, presence of nausea and vomiting)

Other morbidities (wound infection, abdominal abscess, pneumonia, urinary tract infection, bacteraemia, wound dehiscence, marked postoperative bleeding, anastomotic leak, respiratory failure, cardiovascular instability, renal dysfunction, thromboembolic complications)

Participants' satisfaction level and quality of life

Analgesic and antiemetic drug requirements

Notes

Funding source: not reported

Conflicts of interest: not reported

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Quote: "patients were randomized using the web‐based TENALEA randomization system (https://it.tenalea.net/ieo)."

Comment: Computer‐generated sequence

Allocation concealment (selection bias)

Low risk

Quote: "patients were randomized using the web‐based TENALEA randomization system (https://it.tenalea.net/ieo)."

Comment: Central web‐based allocation

Blinding of participants and personnel (performance bias)
All outcomes

High risk

Comment: Because of the study's context, the participants could not be blinded. The physicians taking care of the participants were aware of their study allocation (information from the study's author). It is possible that some outcomes (hospital stay, subjective intestinal morbidities, participants' satisfaction level and quality of life) were influenced by the lack of blinding.

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

Comment: Nursing staff, the primary outcome assessors, were aware of participants' study allocation (information from the study's author). However, the influence of the lack of blinding on study outcomes was unclear.

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Quote: "11 were subsequently excluded (after randomisation) due to postoperative evidence of nongynecologic malignancy (n=3) and admission to ICU for more than 24 h (n=8)."

Comment: Reasons for missing outcome data unlikely to be related to true outcome. Also, the missing outcome data were balanced in numbers across intervention groups, with similar reasons for missing data across groups.

Selective reporting (reporting bias)

Low risk

Comment: The study protocol was published in www.clinicaltrials.gov. The reported outcomes corresponded to those listed in the registered protocol.

Minig 2009b

Methods

A prospective randomised controlled study in a single institution. Power calculation was performed a priori.
Number of participants randomised: 167 (83 in the early group, 84 in the delayed feeding group)
Number of participants analysed: 143 (71 in the early group, 72 in the delayed feeding group), In each group, 12 women were excluded after randomisation because of benign gynaecologic pathology, nongynaecologic pathology, and admission to the ICU for > 24 hours.
Analysis: Available case analysis

Participants

Inclusion criteria: Gynecologic oncology patients aged 18 ‐ 75 years, undergoing laparotomy; mean age: 54 years (early group), 57 years (delayed feeding group).

The majority of participants had ovarian malignancy, 59% in the early group and 57% in the delayed feeding group.Pelvic and aortic lymphadenectomy were performed in > 70% and in almost 50% of participants, respectively. No significant difference in participant characteristics between the two groups.
Location: European Institute of Oncology (IEO), Milan, Italy
Enrolment period: January 1, 2007 to November 15, 2007
Exclusion criteria: Preoperative (infections, intestinal obstruction, severe malnutrition, American Society of Anesthesiologists score > 4), intraoperative (total or anterior pelvic exenteration, bowel resection), postoperative (admission to the intensive care unit for > 24 h, final histopathologic diagnosis revealing benign or nongynaecologic disease)

Interventions

Early group: Participants were offered liquids, mineral water (no gas), tea, chamomile infusion, or apple juice during the first 24 hours. If no nausea and vomiting, a regular diet of boiled or grilled beef, chicken, or fish was given starting on day 1 and continued for the entire hospital stay.
Delayed feeding group: Participants received nothing by mouth until the presence of bowel sound and the passage of flatus. Then, if no nausea and vomiting, an oral liquid diet was given for 24 hours. If well tolerated, a semisolid diet was given for 1 day before proceeding to a regular diet.
Discharge criteria included the tolerance of a regular diet for at least 24 hours with recovery of bowel function, normal clinical parameters and physical examination.

All participants underwent bowel preparation and preoperative antibiotics prophylaxis. In addition, a nasogastric tube was placed in all participants during surgery and was removed after the surgery finished. All participants received general anaesthesia. Postoperative analgesia was given via epidural catheter for 3 days (ropivacaine and fentanyl) or as intravascular continuous administration of ketorolac and tramadol in those without an epidural catheter.

Outcomes

Hospital stay

Recovery of bowel activity (time to first passage of gas and stool, time to tolerance for solid diet)
Intestinal morbidities (presence of ileus, intensity of abdominal pain, presence of nausea and vomiting)

Other morbidities (wound infection, abdominal abscess, pneumonia, urinary tract infection, bacteraemia, wound dehiscence, marked postoperative bleeding, anastomotic leak, respiratory failure, cardiovascular instability, renal dysfunction, thromboembolic complications)

Participants' satisfaction level and quality of life

Analgesic and antiemetic drug requirements

Notes

Funding source: not reported

Conflicts of interest: not reported

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Quote: "patients were randomized by means of the Web‐based Tenalea randomization system (https://it.tenalea.net/ieo)."

Comment: Computer‐generated sequence

Allocation concealment (selection bias)

Low risk

Quote: "patients were randomized by means of the Web‐based Tenalea randomization system (https://it.tenalea.net/ieo)."

Comment: Central web‐based allocation

Blinding of participants and personnel (performance bias)
All outcomes

High risk

Comment: Because of the study's context, the participants could not be blinded. The physicians taking care of the participants were aware of their study allocation (information from the study's author). It is possible that some outcomes (hospital stay, subjective intestinal morbidities, participants' satisfaction level and quality of life) were influenced by the lack of blinding.

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

Comment: Nursing staff, the primary outcome assessors, were aware of participants' study allocation (information from the study's author). However, the influence of the lack of blinding on study outcomes was unclear.

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Quote: "Twenty‐four patients (12 for each group) were subsequently excluded as a result of benign gynecologic pathology, nongynecologic pathology, and admission to the intensive care unit for > 24 h."

Comment: Reasons for missing outcome data unlikely to be related to true outcome. Also, the missing outcome data were balanced in numbers across intervention groups, with similar reasons for missing data across groups.

Selective reporting (reporting bias)

Low risk

Comment: The study protocol was published in www.clinicaltrials.gov. The reported outcomes corresponded to those listed in the registered protocol.

Pearl 1998

Methods

A prospective randomised controlled study in a single institution. Power calculation was performed a priori.
Number of participants randomised: 200 (95 in the early group, 105 in the delayed feeding group)
Number of participants analysed: 195 (92 in the early group, 103 in the delayed feeding group); 5 participants were not measurable because of inoperable bowel obstructions and received gastrostomy tubes: (3 participants; 2 in the early group, 1 in the delayed feeding group) or died of multi‐organ system failure within 36 hours of surgery (1 in each group)
Analysis: Available case analysis

Participants

Inclusion criteria: All gynaecologic oncology patients undergoing non laparoscopic intra‐abdominal surgery
Mean age: 56.5 years (early group), 57.7 years (delayed feeding group)
Underlying diagnosis:‐ Early group: cervical cancer 8.7%, ovarian cancer 30.4%, uterine cancer 38.0%, benign 22.8%
‐ Delayed feeding group: cervical cancer 13.6%, ovarian cancer 33.9%, uterine cancer 24.3%, benign 28.1%
No significant difference in baseline characteristics between the 2 groups including age, disease and surgical procedure distribution, operating time, and estimated blood loss
Location: State University of New York at Stony Brook, Stony Brook, New York, USA
Enrolment period: February 1996 to March 1997
Exclusion criteria were not specified.

Interventions

Early group: Participants began a clear liquid diet on the 1st postoperative day and then advanced to a regular diet as tolerated.
Delayed feeding group: Participants received nothing by mouth until return of bowel function (defined as the passage of flatus in the absence of vomiting or abdominal distention), then began a clear liquid diet, and advanced to a regular diet as tolerated.
All participants had an orogastric tube placed intraoperatively and removed at the completion of surgery.
Participants in either group who were unable to tolerate their diet were given nothing by mouth and received intravenous hydration until resolution of their symptoms, at which time they were restarted on a clear liquid diet and advanced as tolerated. A nasogastric tube was placed for intractable nausea, vomiting, or symptomatic abdominal distention.
Standard criteria for discharge were used for all study participants.

Outcomes

Gastrointestinal information
Morbidity (nausea, vomiting, abdominal distention, nasogastric tube use/duration)
Diet tolerance on 1st attempt of clear liquid and regular diet/ time to tolerance
Postoperative intervals (presence of bowel sounds, passage of flatus, start of clear liquid diet, start of regular diet)

Other morbidities (febrile morbidity, pneumonia, wound complications, atelectasis)

Hospital stay

Notes

Funding source: not reported

Conflicts of interest: not reported

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Quote: "patients were randomized using a computer‐generated random number list."

Comment: Computer‐generated sequence

Allocation concealment (selection bias)

Low risk

Comment: Sequentially numbered, opaque, sealed envelopes

Blinding of participants and personnel (performance bias)
All outcomes

High risk

Comment: Because of the study's context, the participants could not be blinded. The physicians taking care of the participants were aware of their study allocation. It is possible that some outcomes (hospital stay and subjective intestinal morbidities) were influenced by the lack of blinding.

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

Comment: The outcome assessors were not blinded (information from the study's author).

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Quote: "Five patients were nonevaluable, three in the early feeding group and two in the delayed feeding group. Of these, one patient in each group died of multiorgan system failure within 36 hours of surgery. The remaining patients had inoperable bowel obstructions, received gastrostomy tubes, and were placed on hospice care."

Comment: Reasons for missing outcome data unlikely to be related to true outcome. Also, the missing outcome data were balanced in numbers across groups, with similar reasons for missing data.

Selective reporting (reporting bias)

Unclear risk

The study protocol was not published in a protocol registry. However, the report included expected outcomes.

Steed 2002

Methods

A prospective randomised controlled study in a single institution. Participants were randomised by the clinic nurses according to a computer‐generated random number list. Power calculation was performed a priori.
Number of participants randomised: 107
Number of participants analysed: 96 (47 in the early group, 49 in the delayed feeding group); 7 women were excluded because of intraoperative injury of the gastrointestinal tract, and 4 were excluded because of self withdrawal.
Analysis: Available case analysis

Participants

Inclusion criteria: Gynaecologic oncology and uro‐gynaecology patients undergoing laparotomy; mean age: 50 years (early group), 52 years (delayed feeding group)
Underlying diagnosis of malignancy: 63.0% (early group), 54.0% (delayed feeding group)
No significant difference in baseline characteristics between the 2 groups including age, body mass index (BMI), race, malignancy, bowel preparation, procedure, type of incision, operating time, blood loss, need for blood transfusion, and placement of a suprapubic catheter. However, there were significantly more women in early group who received epidural analgesia for pain treatment (55% vs 37%).
Location: Royal Alexandra hospital, Edmonton, Alberta, Canada
Enrolment period: October 2000 to June 2001
Exclusion criteria: Pregnancy, postoperative intensive care unit admission, endotracheal or nasogastric intubations in the immediate postoperative period, perioperative hyperalimentation, history of gastrointestinal surgery (excluding appendectomy) or bowel obstruction, history of pelvic or abdominal radiation, and history of peritonitis

Interventions

Early group: Participants received clear fluids on the 1st postoperative day. After 500 ml of clear fluids was tolerated, a regular solid diet was given.
Delayed feeding group: Participants received nothing by mouth until at least 2 of the following signs of return of bowel function were present: 1) presence of bowel sounds; 2) passage of stool or flatus; 3) subjective hunger. They were then started on clear fluids, and advanced to a regular diet in a stepwise fashion.
If there was evidence of ileus (defined as > 2 episodes of emesis of at least 100 ml each within a 24‐hour time period, with associated abdominal distention and no bowel sounds), participants were treated with restriction of oral intake, intravenous fluids, and nasogastric suction, if necessary.
Discharge criteria included the tolerance of a solid diet, passing flatus, and the discontinuance of intravenous fluids and medications. Participants were not required to have had a bowel movement.

Outcomes

Hospital stay

Gastrointestinal information
Morbidity (incidence and episodes of postoperative ileus)
Time to tolerance of a solid diet

Other morbidities (wound infection, deep venous thrombosis, urinary tract infection, pneumonia, pulmonary oedema)

Notes

Funding source: not reported

Conflicts of interest: not reported

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Quote: "patients were prospectively randomized with a computer‐generated random number list."

Comment: Computer‐generated sequence

Allocation concealment (selection bias)

High risk

Comment: Open random number list

Blinding of participants and personnel (performance bias)
All outcomes

High risk

Comment: Because of the study's context, the participants could not be blinded. The physicians taking care of the participants were aware of their study allocation. It is possible that some outcomes (hospital stay and subjective intestinal morbidities) were influenced by the lack of blinding.

Blinding of outcome assessment (detection bias)
All outcomes

Low risk

Comment: The outcome assessors were blinded.

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Quote: "Seven women were excluded because of intraoperative injury of the gastrointestinal tract, and 4 patients were excluded because of self‐withdrawal."

Comment: Reasons for missing outcome data unlikely to be related to true outcome.

Selective reporting (reporting bias)

Unclear risk

The study protocol was not published in a protocol registry. However, the report included expected outcomes.

Characteristics of excluded studies [ordered by study ID]

Study

Reason for exclusion

Cutillo 1999

This study compared early feeding with nasogastric decompression after major gynaecologic oncology surgery, not early versus delayed (traditional) feeding schedule.

Delaney 2005

This study compared different doses of alvimopan and placebo after partial colectomy or simple/radical hysterectomy, not early versus delayed (traditional) feeding schedule.

Fanning 1999

This is a non‐comparative study on effects of aggressive postradical hysterectomy bowel stimulation, which consisted of milk of magnesia and bis colic suppositories.

Fanning 2011

This is a non‐comparative study that examined the effects of immediate postoperative feeding and bowel stimulation in 707 women who had major gynaecologic operations over a 5‐year period.

Feng 2008

This is a randomised controlled study that compared a semiliquid diet with clear feeds, both started at 6 hours after major abdominal gynaecological oncology surgery. The types of diet for early feeding were compared, not the timing.

Finan 1995

This study compared administration of water‐soluble, hyperosmolar, radio‐opaque contrast material and conventional management after gynaecologic surgery, not early versus delayed (traditional) feeding schedule.

Griffenberg 1997

This study compared a high‐fibre diet plan or their usual diet after radical hysterectomy, not early versus delayed (traditional) feeding schedule.

Kraus 2000

This is a non‐comparative study on effects of aggressive postradical hysterectomy bowel stimulation with oral 66% sodium phosphate solution.

MacMillan 2000

Participants had several different types of major gynaecologic surgeries, including abdominal and vaginal approaches, and were randomly allocated to feeding groups regardless of approach.

Pearl 2002

This study compared a regular diet with clear liquid as the first meal after intra‐abdominal gynaecologic oncology surgery, not early versus delayed (traditional) feeding schedule.

Schilder 1997

Although this prospective study compared early versus delayed (traditional) feeding after gynaecological surgery, the design was quasi‐randomisation.

Taguchi 2001

This study compared different doses of ADL 8‐2698, an investigational opioid antagonist and placebo after partial colectomy or simple hysterectomy, not early versus delayed (traditional) feeding schedule.

Terzioglu 2013

This is a randomised controlled study that compared 8 different combinations of postoperative interventions including gum chewing, early oral hydration, and early mobilisation following abdominal gynaecologic surgery.

Data and analyses

Open in table viewer
Comparison 1. Early versus delayed oral fluids and food after major abdominal gynaecologic surgery

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Postoperative ileus Show forest plot

5

Risk Ratio (M‐H, Fixed, 95% CI)

Subtotals only

Analysis 1.1

Comparison 1 Early versus delayed oral fluids and food after major abdominal gynaecologic surgery, Outcome 1 Postoperative ileus.

Comparison 1 Early versus delayed oral fluids and food after major abdominal gynaecologic surgery, Outcome 1 Postoperative ileus.

1.1 Postoperative ileus

3

279

Risk Ratio (M‐H, Fixed, 95% CI)

0.47 [0.17, 1.29]

1.2 Nausea and/or vomiting (fixed‐effect model)

4

484

Risk Ratio (M‐H, Fixed, 95% CI)

1.10 [0.88, 1.38]

1.3 Nausea

1

195

Risk Ratio (M‐H, Fixed, 95% CI)

1.79 [1.19, 2.71]

1.4 Vomiting

2

301

Risk Ratio (M‐H, Fixed, 95% CI)

0.86 [0.37, 2.00]

1.5 Abdominal distension

2

301

Risk Ratio (M‐H, Fixed, 95% CI)

1.07 [0.77, 1.47]

1.6 Postoperative placement of nasogastric tube

1

195

Risk Ratio (M‐H, Fixed, 95% CI)

0.48 [0.13, 1.80]

2 Time intervals (fixed‐effect model) [days] Show forest plot

4

Mean Difference (IV, Fixed, 95% CI)

Subtotals only

Analysis 1.2

Comparison 1 Early versus delayed oral fluids and food after major abdominal gynaecologic surgery, Outcome 2 Time intervals (fixed‐effect model) [days].

Comparison 1 Early versus delayed oral fluids and food after major abdominal gynaecologic surgery, Outcome 2 Time intervals (fixed‐effect model) [days].

2.1 Time to the presence of bowel sound (fixed‐effect model) [days]

2

338

Mean Difference (IV, Fixed, 95% CI)

‐0.29 [‐0.48, ‐0.11]

2.2 Time to the passage of flatus [days]

3

444

Mean Difference (IV, Fixed, 95% CI)

‐0.21 [‐0.40, ‐0.01]

2.3 Time to the first solid diet (fixed‐effect model) [days]

2

301

Mean Difference (IV, Fixed, 95% CI)

‐1.19 [‐1.34, ‐1.05]

2.4 Time to the first passage of stool [days]

2

249

Mean Difference (IV, Fixed, 95% CI)

‐0.25 [‐0.58, 0.09]

2.5 Hospital stay (fixed‐effect model) [days]

4

484

Mean Difference (IV, Fixed, 95% CI)

‐0.59 [‐0.83, ‐0.35]

3 Other major postoperative complications Show forest plot

4

1286

Risk Ratio (M‐H, Fixed, 95% CI)

0.80 [0.63, 1.01]

Analysis 1.3

Comparison 1 Early versus delayed oral fluids and food after major abdominal gynaecologic surgery, Outcome 3 Other major postoperative complications.

Comparison 1 Early versus delayed oral fluids and food after major abdominal gynaecologic surgery, Outcome 3 Other major postoperative complications.

3.1 Febrile morbidity

1

195

Risk Ratio (M‐H, Fixed, 95% CI)

0.98 [0.76, 1.27]

3.2 Infectious complications

2

183

Risk Ratio (M‐H, Fixed, 95% CI)

0.20 [0.05, 0.73]

3.3 Wound complications

4

474

Risk Ratio (M‐H, Fixed, 95% CI)

0.82 [0.50, 1.35]

3.4 Pneumonia

3

434

Risk Ratio (M‐H, Fixed, 95% CI)

0.35 [0.07, 1.73]

4 Satisfaction visual analog scale [mm] Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Subtotals only

Analysis 1.4

Comparison 1 Early versus delayed oral fluids and food after major abdominal gynaecologic surgery, Outcome 4 Satisfaction visual analog scale [mm].

Comparison 1 Early versus delayed oral fluids and food after major abdominal gynaecologic surgery, Outcome 4 Satisfaction visual analog scale [mm].

5 Nausea and/or vomiting (random‐effects model) Show forest plot

4

484

Risk Ratio (M‐H, Random, 95% CI)

1.03 [0.64, 1.67]

Analysis 1.5

Comparison 1 Early versus delayed oral fluids and food after major abdominal gynaecologic surgery, Outcome 5 Nausea and/or vomiting (random‐effects model).

Comparison 1 Early versus delayed oral fluids and food after major abdominal gynaecologic surgery, Outcome 5 Nausea and/or vomiting (random‐effects model).

6 Time to the presence of bowel sound (random‐effects model) [days] Show forest plot

2

338

Mean Difference (IV, Random, 95% CI)

‐0.32 [‐0.61, ‐0.03]

Analysis 1.6

Comparison 1 Early versus delayed oral fluids and food after major abdominal gynaecologic surgery, Outcome 6 Time to the presence of bowel sound (random‐effects model) [days].

Comparison 1 Early versus delayed oral fluids and food after major abdominal gynaecologic surgery, Outcome 6 Time to the presence of bowel sound (random‐effects model) [days].

7 Time to the first solid diet (random‐effects model) [days] Show forest plot

2

301

Mean Difference (IV, Random, 95% CI)

‐1.47 [‐2.26, ‐0.68]

Analysis 1.7

Comparison 1 Early versus delayed oral fluids and food after major abdominal gynaecologic surgery, Outcome 7 Time to the first solid diet (random‐effects model) [days].

Comparison 1 Early versus delayed oral fluids and food after major abdominal gynaecologic surgery, Outcome 7 Time to the first solid diet (random‐effects model) [days].

8 Hospital stay (random‐effects model) [days] Show forest plot

4

484

Mean Difference (IV, Random, 95% CI)

‐0.92 [‐1.53, ‐0.31]

Analysis 1.8

Comparison 1 Early versus delayed oral fluids and food after major abdominal gynaecologic surgery, Outcome 8 Hospital stay (random‐effects model) [days].

Comparison 1 Early versus delayed oral fluids and food after major abdominal gynaecologic surgery, Outcome 8 Hospital stay (random‐effects model) [days].

Study flow diagram.
Figuras y tablas -
Figure 1

Study flow diagram.

Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
Figuras y tablas -
Figure 2

Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.

Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
Figuras y tablas -
Figure 3

Risk of bias summary: review authors' judgements about each risk of bias item for each included study.

Comparison 1 Early versus delayed oral fluids and food after major abdominal gynaecologic surgery, Outcome 1 Postoperative ileus.
Figuras y tablas -
Analysis 1.1

Comparison 1 Early versus delayed oral fluids and food after major abdominal gynaecologic surgery, Outcome 1 Postoperative ileus.

Comparison 1 Early versus delayed oral fluids and food after major abdominal gynaecologic surgery, Outcome 2 Time intervals (fixed‐effect model) [days].
Figuras y tablas -
Analysis 1.2

Comparison 1 Early versus delayed oral fluids and food after major abdominal gynaecologic surgery, Outcome 2 Time intervals (fixed‐effect model) [days].

Comparison 1 Early versus delayed oral fluids and food after major abdominal gynaecologic surgery, Outcome 3 Other major postoperative complications.
Figuras y tablas -
Analysis 1.3

Comparison 1 Early versus delayed oral fluids and food after major abdominal gynaecologic surgery, Outcome 3 Other major postoperative complications.

Comparison 1 Early versus delayed oral fluids and food after major abdominal gynaecologic surgery, Outcome 4 Satisfaction visual analog scale [mm].
Figuras y tablas -
Analysis 1.4

Comparison 1 Early versus delayed oral fluids and food after major abdominal gynaecologic surgery, Outcome 4 Satisfaction visual analog scale [mm].

Comparison 1 Early versus delayed oral fluids and food after major abdominal gynaecologic surgery, Outcome 5 Nausea and/or vomiting (random‐effects model).
Figuras y tablas -
Analysis 1.5

Comparison 1 Early versus delayed oral fluids and food after major abdominal gynaecologic surgery, Outcome 5 Nausea and/or vomiting (random‐effects model).

Comparison 1 Early versus delayed oral fluids and food after major abdominal gynaecologic surgery, Outcome 6 Time to the presence of bowel sound (random‐effects model) [days].
Figuras y tablas -
Analysis 1.6

Comparison 1 Early versus delayed oral fluids and food after major abdominal gynaecologic surgery, Outcome 6 Time to the presence of bowel sound (random‐effects model) [days].

Comparison 1 Early versus delayed oral fluids and food after major abdominal gynaecologic surgery, Outcome 7 Time to the first solid diet (random‐effects model) [days].
Figuras y tablas -
Analysis 1.7

Comparison 1 Early versus delayed oral fluids and food after major abdominal gynaecologic surgery, Outcome 7 Time to the first solid diet (random‐effects model) [days].

Comparison 1 Early versus delayed oral fluids and food after major abdominal gynaecologic surgery, Outcome 8 Hospital stay (random‐effects model) [days].
Figuras y tablas -
Analysis 1.8

Comparison 1 Early versus delayed oral fluids and food after major abdominal gynaecologic surgery, Outcome 8 Hospital stay (random‐effects model) [days].

Summary of findings for the main comparison. Early oral feeding compared to delayed oral feeding for women who had major abdominal gynaecologic surgery

Early oral feeding compared to delayed oral feeding for women who had major abdominal gynaecologic surgery

Patient or population: Women who had major abdominal gynaecologic surgery
Settings: University hospital/cancer centre
Intervention: Early oral feeding
Comparison: Delayed (traditional) oral feeding

Outcomes

Illustrative comparative risks* (95% CI)

Relative effect
(95% CI)

No of Participants
(studies)

Quality of the evidence
(GRADE)

Comments

Assumed risk

Corresponding risk

Delayed oral feeding

Early oral feeding

Postoperative ileus

77 per 1000

36 per 1000
(13 to 99)

RR 0.47
(0.17 to 1.29)

279
(3 studies)

⊕⊕⊕⊝
moderate1

Nausea or vomiting or both

352 per 1000

363 per 1000
(225 to 588)

RR 1.03
(0.64 to 1.67)

484
(4 studies)

⊕⊕⊕⊝
moderate2

Random effects model, deployed because of substantial heterogeneity between studies (I2> 50%)

Time to bowel sounds [days]

The mean time to the presence of bowel sound [days] in the intervention groups was
0.32 lower
(0.61 to 0.03 lower)

338
(2 studies)

⊕⊕⊕⊝
moderate3

Random effects model, deployed because of substantial heterogeneity between studies (I2> 50%)

Time to the passage of flatus [days]

The mean time to the passage of flatus [days] in the intervention groups was
0.21 lower
(0.4 to 0.01 lower)

444
(3 studies)

⊕⊕⊕⊕
high

Time to the first solid diet [days]

The mean time to the first solid diet [days] in the intervention groups was
1.47 lower
(2.26 to 0.68 lower)

301
(2 studies)

⊕⊕⊕⊝
moderate3

Random effects model, deployed because of substantial heterogeneity between studies (I2> 50%)

Time to first passage of stool [days]

The mean time to first passage of stool [days] in the intervention groups was
0.25 lower
(0.58 lower to 0.09 higher)

249
(2 studies)

⊕⊕⊕⊝
moderate3

Hospital stay [days]

The mean hospital stay [days] in the intervention groups was
0.92 lower
(1.53 to 0.31 lower)

484
(4 studies)

⊕⊕⊕⊝
moderate4

Random effects model, deployed because of substantial heterogeneity between studies (I2> 50%)

*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
CI: Confidence interval; RR: Risk ratio;

GRADE Working Group grades of evidence
High quality: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: We are very uncertain about the estimate.

1 For the three studies contributing data, all were at high risk of performance bias, two were at unclear risk of detection bias, and one was at high risk of selection bias (no allocation concealment).
2 For the four studies contributing data, all were at high risk of performance bias and unclear risk of detection bias.
3 This outcome may be influenced by the high risk of performance bias in the two studies that contributed data.

4 This outcome may be influenced by the high risk of performance bias in all studies that provided data.

Figuras y tablas -
Summary of findings for the main comparison. Early oral feeding compared to delayed oral feeding for women who had major abdominal gynaecologic surgery
Comparison 1. Early versus delayed oral fluids and food after major abdominal gynaecologic surgery

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Postoperative ileus Show forest plot

5

Risk Ratio (M‐H, Fixed, 95% CI)

Subtotals only

1.1 Postoperative ileus

3

279

Risk Ratio (M‐H, Fixed, 95% CI)

0.47 [0.17, 1.29]

1.2 Nausea and/or vomiting (fixed‐effect model)

4

484

Risk Ratio (M‐H, Fixed, 95% CI)

1.10 [0.88, 1.38]

1.3 Nausea

1

195

Risk Ratio (M‐H, Fixed, 95% CI)

1.79 [1.19, 2.71]

1.4 Vomiting

2

301

Risk Ratio (M‐H, Fixed, 95% CI)

0.86 [0.37, 2.00]

1.5 Abdominal distension

2

301

Risk Ratio (M‐H, Fixed, 95% CI)

1.07 [0.77, 1.47]

1.6 Postoperative placement of nasogastric tube

1

195

Risk Ratio (M‐H, Fixed, 95% CI)

0.48 [0.13, 1.80]

2 Time intervals (fixed‐effect model) [days] Show forest plot

4

Mean Difference (IV, Fixed, 95% CI)

Subtotals only

2.1 Time to the presence of bowel sound (fixed‐effect model) [days]

2

338

Mean Difference (IV, Fixed, 95% CI)

‐0.29 [‐0.48, ‐0.11]

2.2 Time to the passage of flatus [days]

3

444

Mean Difference (IV, Fixed, 95% CI)

‐0.21 [‐0.40, ‐0.01]

2.3 Time to the first solid diet (fixed‐effect model) [days]

2

301

Mean Difference (IV, Fixed, 95% CI)

‐1.19 [‐1.34, ‐1.05]

2.4 Time to the first passage of stool [days]

2

249

Mean Difference (IV, Fixed, 95% CI)

‐0.25 [‐0.58, 0.09]

2.5 Hospital stay (fixed‐effect model) [days]

4

484

Mean Difference (IV, Fixed, 95% CI)

‐0.59 [‐0.83, ‐0.35]

3 Other major postoperative complications Show forest plot

4

1286

Risk Ratio (M‐H, Fixed, 95% CI)

0.80 [0.63, 1.01]

3.1 Febrile morbidity

1

195

Risk Ratio (M‐H, Fixed, 95% CI)

0.98 [0.76, 1.27]

3.2 Infectious complications

2

183

Risk Ratio (M‐H, Fixed, 95% CI)

0.20 [0.05, 0.73]

3.3 Wound complications

4

474

Risk Ratio (M‐H, Fixed, 95% CI)

0.82 [0.50, 1.35]

3.4 Pneumonia

3

434

Risk Ratio (M‐H, Fixed, 95% CI)

0.35 [0.07, 1.73]

4 Satisfaction visual analog scale [mm] Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Subtotals only

5 Nausea and/or vomiting (random‐effects model) Show forest plot

4

484

Risk Ratio (M‐H, Random, 95% CI)

1.03 [0.64, 1.67]

6 Time to the presence of bowel sound (random‐effects model) [days] Show forest plot

2

338

Mean Difference (IV, Random, 95% CI)

‐0.32 [‐0.61, ‐0.03]

7 Time to the first solid diet (random‐effects model) [days] Show forest plot

2

301

Mean Difference (IV, Random, 95% CI)

‐1.47 [‐2.26, ‐0.68]

8 Hospital stay (random‐effects model) [days] Show forest plot

4

484

Mean Difference (IV, Random, 95% CI)

‐0.92 [‐1.53, ‐0.31]

Figuras y tablas -
Comparison 1. Early versus delayed oral fluids and food after major abdominal gynaecologic surgery