Prophylactic abdominal drainage for pancreatic surgery

Wei Zhang; Sirong He<sup>a</sup>; Yao Cheng; Jie Xia; Mingliang Lai; Nansheng Cheng; Zuojin Liu

doi:10.1002/14651858.CD010583.pub4

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Referencias

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ISRCTN04937707. Intra‐abdominal drainage for two days versus no drainage following pancreas resection. isrctn.com/ISRCTN04937707 (first received 27 June 2007).

Witzigmann H, Diener MK, Kienkötter S, Rossion I, Bruckner T, Werner B, et al. No need for routine drainage after pancreatic head resection: the dual‐center, randomized, controlled PANDRA trial. Annals of Surgery 2016;264(3):528‐37. [Trial registration #ISRCTN04937707]

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منابع مطالعات واردشده در این مرور
منابع مطالعات خارج‌شده از این مرور
منابع مطالعات در حال انجام
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منابع مطالعات واردشده در این مرور
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Cheng Y, Yang C, Lin Y, Lu J, Wu S, Zhou R, et al. Prophylactic abdominal drainage for pancreatic surgery. Cochrane Database of Systematic Reviews 2013, Issue 6. [DOI: 10.1002/14651858.CD010583]

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Characteristics of studies

Characteristics of included studies [ordered by study ID]

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estudios excluidos
estudios en curso

Bassi 2010

Methods	Randomized controlled trial
Participants	Country: Italy Number randomized: 114 Postrandomization dropout: 0 (0%) Mean age: 56.6 years Females: 55 (48.2%) Pancreatic cancer: 56 (49.1%) Biliary cancer: 2 (1.8%) Ampullary cancer: 7 (6.1%) Chronic pancreatitis: 3 (2.6%) Other: 46 (40.4%) Pancreaticoduodenectomy: 75 (65.8%) Distal pancreatectomy: 39 (34.2%) Other pancreatic surgery: 0 (0%) Inclusion criteria: Participants had undergone either pancreaticoduodenectomy (reconstruction by pancreaticojejunostomy) or distal pancreatectomy An amylase value in drains on postoperative day 1 < 5000 IU/L Exclusion criteria: Reconstruction of the pancreatic remnant by pancreaticogastrostomy Clinical suspicion of post‐pancreatectomy haemorrhage or re‐laparotomy within 72 hours from index operation Appearance of drain effluent or clinical suspect of biliary fistula within 72 hours of index operation Peripancreatic fluid collection > 5 cm (maximum diameter) at a routine transabdominal ultrasound performed
Interventions	Participants (N = 114) were randomly assigned to 1 of 2 groups Group 1: early drain removal (postoperative day 3; N = 57) Group 2: late drain removal (postoperative day 5 or later; N = 57)
Outcomes	Pancreatic fistula, abdominal complications, pulmonary complications, reoperation, length of hospital stay, hospital readmission, postoperative mortality, morbidity, and hospital costs
Notes	Two drainage tubes (Penrose drains) were placed in relation to the pancreatic and biliary anastomoses through separate skin incisions after pancreaticoduodenectomy. One drainage tube was placed in relation to the pancreatic stump through separate skin incisions after distal pancreatectomy.
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "eligible patients were randomized by a computer‐generated allocation schedule"
Allocation concealment (selection bias)	Unclear risk	Comment: no information provided
Blinding of outcome assessment (detection bias) All outcomes	High risk	Quote: "Masking: Open Label" in the protocol
Incomplete outcome data (attrition bias) All outcomes	Low risk	Comment: there were no postrandomization dropouts
Selective reporting (reporting bias)	Low risk	Comment: the study protocol was available (NCT00931554). All of the study's prespecified outcomes were reported.
Other bias	Low risk	Comment: the study appeared to be free of other sources of bias

Conlon 2001

Methods	Randomized controlled trial
Participants	Country: USA Number randomized: 179 Postrandomization dropout: 0 (0%) Mean age: 65.4 years Females: 90 (50.3%) Pancreatic cancer: 142 (79.3%) Biliary cancer: 3 (1.7%) Duodenal cancer: 10 (5.6%) Ampullary cancer: 24 (13.4%) Chronic pancreatitis: 0 (0%) Pancreaticoduodenectomy: 139 (77.7%) Distal pancreatectomy: 40 (22.3%) Other pancreatic surgery: 0 (0%) Inclusion criteria: Adults People with peripancreatic tumors People who had undergone either pancreaticoduodenectomy or distal pancreatectomy Exclusion criteria: People who had undergone a recent exploration before presentation People who had evidence of intra‐abdominal sepsis
Interventions	Participants (N = 179) were randomly assigned to 1 of 2 groups Group 1: drainage (N = 91) Group 2: no drainage (N = 88)
Outcomes	Mortality, morbidity, wound infection, intra‐abdominal infection, various postoperative complications, reoperation, additional radiological intervention, and length of hospital stay
Notes	Two drainage tubes (Jackson‐Pratt closed suction drains) were placed in relation to the pancreatic and biliary anastomoses through separate skin incisions after pancreaticoduodenectomy. One drainage tube was placed in relation to the pancreatic stump through separate skin incisions after distal pancreatectomy.
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Comment: no information provided
Allocation concealment (selection bias)	Unclear risk	Quote: "patients were randomized during surgery by the envelope method" Comment: no information was provided whether the envelope was opaque or not
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Comment: no information provided
Incomplete outcome data (attrition bias) All outcomes	Low risk	Comment: there were no postrandomization dropouts
Selective reporting (reporting bias)	Low risk	Comment: all of the study's prespecified outcomes in the method section were reported
Other bias	Low risk	Comment: the study appeared to be free of other sources of bias

Jiang 2016

Methods	Randomized controlled trial
Participants	Country: China Number randomized: 160 Postrandomization dropout: 0 (0%) Mean age: 59.6 years Females: 42 (26.3%) Pancreatic cancer: 53 (33.1%) Biliary cancer: 36 (22.5%) Duodenal cancer: 28 (17.5%) Ampullary cancer: 33 (20.6%) Chronic pancreatitis: 5 (3.1%) Pancreaticoduodenectomy: 160 (100%) Distal pancreatectomy: 0 (0%) Other pancreatic surgery: 0 (0%) Inclusion criteria: People with planned pancreaticoduodenectomy Exclusion criteria: People who had undergone explorative laparotomy People who had undergone distal pancreatectomy
Interventions	Participants (N = 160) were randomly assigned to 1 of 2 groups Group 1: active drain (N = 82) Group 2: passive drain (N = 78)
Outcomes	Mortality, morbidity, wound infection, intra‐abdominal infection, various postoperative complications, reoperation, readmission, additional radiological intervention, and length of hospital stay
Notes
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "we randomized our patients using a computer‐generated random number"
Allocation concealment (selection bias)	Unclear risk	Comment: no information provided
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Quote: "Patients were prospectively assigned a code and data were recorded in a database by two nurses" Comment: no information provided whether the 2 nurses were blinded
Incomplete outcome data (attrition bias) All outcomes	Low risk	Comment: there were no postrandomization dropouts
Selective reporting (reporting bias)	Low risk	Comment: all of the study's prespecified outcomes in the method section were reported
Other bias	Low risk	Comment: the study appeared to be free of other sources of bias

Van Buren 2014

Methods	Randomized controlled trial
Participants	Country: USA Number randomized: 137 Postrandomization dropout: 3 (2.2%) Mean age: 63.2 years Females: 62 (45.3%) Pancreatic cancer: 67 (48.9%) Biliary cancer: not mentioned Duodenal cancer: not mentioned Ampullary cancer: 17 (12.4%) Chronic pancreatitis: 15 (10.9%) Pancreaticoduodenectomy: 137 (100%) Distal pancreatectomy: 0 (0%) Other pancreatic surgery: 0 (0%) Inclusion criteria: The participant had a surgical indication for distal pancreatectomy In the opinion of the surgeon, the participant had no medical contraindications to pancreatectomy Aged ≥ 18 years The participant was willing to consent to randomization to the intraperitoneal drain or no drain group The participant was willing to comply with 90‐day follow‐up and answer quality‐of‐life questionnaires per protocol Exclusion criteria: People who refused to be randomized People who withdrew their consent before surgery People who were found to have unresectable disease at the time of exploration, or had an enucleation, or a total pancreatectomy rather than a pancreaticoduodenectomy
Interventions	Participants (N = 137) were randomly assigned to 1 of 2 groups Group 1: drainage (N = 68) Group 2: no drainage (N = 69)
Outcomes	Mortality, morbidity, wound infection, intra‐abdominal infection, various postoperative complications, reoperation, readmission, additional radiologic intervention, and length of hospital stay
Notes
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "Randomization was performed using a computerized randomization system at the coordinating center"
Allocation concealment (selection bias)	Unclear risk	Comment: no information provided
Blinding of outcome assessment (detection bias) All outcomes	High risk	Quote: "Masking: open label"
Incomplete outcome data (attrition bias) All outcomes	High risk	Quote: "There were 3 cases for which the randomization group assignment was inadvertently not followed"
Selective reporting (reporting bias)	Low risk	Comment: the study protocol was available (NCT01441492). All of the study's prespecified outcomes were reported.
Other bias	Low risk	Comment: the study appeared to be free of other sources of bias

Van Buren 2017

Methods	Randomized controlled trial
Participants	Country: USA and Canada Number randomized: 399 Postrandomization dropout: 55 (13.8%) Mean age: 61.0 years Females: 205 (60.0%) Pancreatic cancer: 171 (49.7%) Biliary cancer: not mentioned Duodenal cancer: not mentioned Ampullary cancer: not mentioned Chronic pancreatitis: 33 (9.6%) Pancreaticoduodenectomy: 0 (0%) Distal pancreatectomy: 344 (100%) Other pancreatic surgery: 0 (0%) Inclusion criteria: The participant had a surgical indication for distal pancreatectomy In the opinion of the surgeon, the participant had no medical contraindications to distal pancreatectomy Age ≥ 18 years The participant was willing to consent to randomization to the intraperitoneal drain or no drain group The participant was willing to comply with 30‐day and 60‐day follow‐up in the office and answer quality‐of‐life questionnaires per protocol The participant was willing to comply with 90‐day follow‐up by phone Exclusion criteria: People who refused to be randomized People who withdrew their consent before surgery People who were found to have unresectable disease at the time of exploration, or had an enucleation, or a total pancreatectomy rather than a pancreaticoduodenectomy People who required any type of pancreas resection other than a distal pancreatectomy In the opinion of the surgeon, the participant had medical contraindications to distal pancreatectomy Age < 18 years The subject was not willing to consent to randomization to the intraperitoneal drain or no drain group The subject was not willing to comply with 30‐day and 60‐day follow‐up in the office and answer quality‐of‐life questionnaires per protocol The subject was not willing to comply with 90‐day follow‐up by phone
Interventions	Participants (N = 399) were randomly assigned to 1 of 2 groups Group 1: drainage (N = 202) Group 2: no drainage (N = 197)
Outcomes	Mortality, morbidity, wound infection, intra‐abdominal infection, various postoperative complications, reoperation, readmission, additional radiologic intervention, length of hospital stay, and quality of life
Notes
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "Patients were randomized preoperatively to DP with or without intraperitoneal drain placement using a computerized randomization system at the coordinating center"
Allocation concealment (selection bias)	Unclear risk	Comment: no information provided
Blinding of outcome assessment (detection bias) All outcomes	High risk	Quote: "Masking: open label"
Incomplete outcome data (attrition bias) All outcomes	High risk	Quote: "There were 55 patients who were excluded from the study after randomization and were not followed. Four patients, 2 in each group, were lost to follow‐up and excluded from the analysis".
Selective reporting (reporting bias)	Low risk	Comment: the study protocol was available (NCT01441492). All of the study's prespecified outcomes were reported.
Other bias	Low risk	Comment: the study appeared to be free of other sources of bias

Witzigmann 2016

Methods	Randomized controlled trial
Participants	Country: Germany Number randomized: 438 Postrandomization dropout: 43 (2.2%) Mean age: 63.4 years Females: 139 (35.2%) Pancreatic cancer: 159 (40.3%) Biliary cancer: 23 (5.8%) Duodenal cancer: 5 (1.3%) Ampullary cancer: 19 (4.8%) Chronic pancreatitis: 101 (25.6%) Pancreaticoduodenectomy: 328 (83.0%) Distal pancreatectomy: 0 (0%) Other pancreatic surgery: 67 (17.0%) Inclusion criteria: Aged ≥ 18 years People planned for pancreatic head resection with pancreaticojejunal anastomosis for benign or malignant tumors, chronic pancreatitis, or other indications Exclusion criteria: People who underwent extended resection People who had a cardiac infarction within 6 months before operation Malignancy that had not responded to treatment within 5 years before operation Lack of compliance Pregnancy or lactation Participation in another trial that may interfere with the intervention or outcome
Interventions	Participants (N = 395) were randomly assigned to 1 of 2 groups Group 1: drainage (N = 202) Group 2: no drainage (N = 193)
Outcomes	Mortality, morbidity, wound infection, intra‐abdominal infection, various postoperative complications, reoperation, operation time, and length of hospital stay
Notes
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "A random list was created by GWT‐TUD Ltd"
Allocation concealment (selection bias)	Low risk	Quote: "The random allocation sequence was implemented by the use of sequentially numbered opaque envelopes"
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Comment: no information provided
Incomplete outcome data (attrition bias) All outcomes	High risk	Quote: "A total of 438 patients were randomized. Forty‐three patients (9.8%) were excluded because no pancreatic resection with consecutive pancreaticojejunal anastomosis was performed. Thus, the intention‐to‐treat population consisted of 395 patients". Comment: there are 43 postrandomization dropouts. The study did not perform an intention‐to‐treat analysis which included the 43 dropouts.
Selective reporting (reporting bias)	Low risk	Comment: the study protocol was available (ISRCTN04937707). All of the study's prespecified outcomes were reported.
Other bias	Low risk	Comment: the study appeared to be free of other sources of bias

DP: distal pancreatectomy; IU: international unit; N: number of participants.

Characteristics of excluded studies [ordered by study ID]

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estudios incluidos
estudios en curso

Study	Reason for exclusion
Adham 2013	A non‐randomized study
Behrman 2015	A non‐randomized study
Correa‐Gallego 2013	A non‐randomized study
Fisher 2011	A non‐randomized study
Giovinazzo 2011	A non‐randomized study
Heslin 1998	A non‐randomized study
Jeekel 1992	Case series
Kawai 2006	A non‐randomized study
Kunstman 2017	A non‐randomized study
Lee 2009	Randomized controlled trial about pancreatic duct drainage
Lim 2013	A non‐randomized study
Mehta 2013	A non‐randomized study
Paulus 2012	A non‐randomized study

Characteristics of ongoing studies [ordered by study ID]

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estudios incluidos
estudios excluidos

Čečka 2015

Trial name or title	DRAPA Trial ‐ Closed‐suction drains versus closed gravity drains in pancreatic surgery: study protocol for a randomized controlled trial
Methods	Randomized controlled trial
Participants	Country: Czech Republic Number of enrolment: 223 Inclusion criteria: People scheduled for primary pancreaticoduodenectomy or distal pancreatic resection in participating centers Aged ≥ 18 years Signed informed consent provided Exclusion criteria: No pancreatic resection performed: non‐resectable tumor Total pancreatectomy, central pancreatectomy, or enucleation Multivisceral resection Laparoscopic procedure Resection of the portal vein and reconstruction with a graft Lack of compliance, informed consent not provided, or refusal to participate
Interventions	Participants are randomly assigned to 1 or 2 groups Group 1: closed suction drain (active drain) Group 2: closed gravity drain (passive drain)
Outcomes	Primary outcome: rate of postoperative pancreatic fistula Secondary outcomes: postoperative morbidity, including wound infection, intra‐abdominal collections, delayed gastric emptying, postoperative hemorrhage, pneumonia, abdominal rupture, cardiac events, and neurological complications
Starting date	October 2013
Contact information	Principal investigator: Filip Čečka, Department of Surgery, University Hospital Hradec Kralove, Hradec Kralove, Czech Republic, 50005 Tel: +42049583 ext 4272 Email: [email protected]
Notes

Data and analyses

Open in table viewer

Comparison 1. Drain use versus no drain use

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Mortality (30 days) Show forest plot	3	711	Risk Ratio (M‐H, Random, 95% CI)	0.78 [0.31, 1.99]
Open in figure viewer Analysis 1.1 Comparison 1 Drain use versus no drain use, Outcome 1 Mortality (30 days).
2 Mortality (90 days) Show forest plot	2	478	Risk Ratio (M‐H, Random, 95% CI)	0.23 [0.06, 0.90]
Open in figure viewer Analysis 1.2 Comparison 1 Drain use versus no drain use, Outcome 2 Mortality (90 days).
3 Intra‐abdominal infection Show forest plot	4	1055	Risk Ratio (M‐H, Random, 95% CI)	0.97 [0.52, 1.80]
Open in figure viewer Analysis 1.3 Comparison 1 Drain use versus no drain use, Outcome 3 Intra‐abdominal infection.
4 Wound infection Show forest plot	4	1055	Risk Ratio (M‐H, Random, 95% CI)	0.98 [0.68, 1.41]
Open in figure viewer Analysis 1.4 Comparison 1 Drain use versus no drain use, Outcome 4 Wound infection.
5 Morbidity Show forest plot	4	1055	Risk Ratio (M‐H, Random, 95% CI)	1.03 [0.94, 1.13]
Open in figure viewer Analysis 1.5 Comparison 1 Drain use versus no drain use, Outcome 5 Morbidity.
6 Length of hospital stay (days) Show forest plot	3	711	Mean Difference (IV, Random, 95% CI)	‐0.66 [‐1.60, 0.29]
Open in figure viewer Analysis 1.6 Comparison 1 Drain use versus no drain use, Outcome 6 Length of hospital stay (days).
7 Additional open procedures for postoperative complications Show forest plot	4	1055	Risk Ratio (M‐H, Random, 95% CI)	1.33 [0.79, 2.23]
Open in figure viewer Analysis 1.7 Comparison 1 Drain use versus no drain use, Outcome 7 Additional open procedures for postoperative complications.
8 Additional radiological interventions for postoperative complications Show forest plot	3	660	Risk Ratio (M‐H, Random, 95% CI)	0.87 [0.40, 1.87]
Open in figure viewer Analysis 1.8 Comparison 1 Drain use versus no drain use, Outcome 8 Additional radiological interventions for postoperative complications.

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Comparison 2. Active drain versus passive drain

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Mortality (30 days) Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected
Open in figure viewer Analysis 2.1 Comparison 2 Active drain versus passive drain, Outcome 1 Mortality (30 days).
2 Intra‐abdominal infection Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected
Open in figure viewer Analysis 2.2 Comparison 2 Active drain versus passive drain, Outcome 2 Intra‐abdominal infection.
3 Wound infection Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected
Open in figure viewer Analysis 2.3 Comparison 2 Active drain versus passive drain, Outcome 3 Wound infection.
4 Morbidity Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected
Open in figure viewer Analysis 2.4 Comparison 2 Active drain versus passive drain, Outcome 4 Morbidity.
5 Length of hospital stay (days) Show forest plot	1		Mean Difference (IV, Random, 95% CI)	Totals not selected
Open in figure viewer Analysis 2.5 Comparison 2 Active drain versus passive drain, Outcome 5 Length of hospital stay (days).
6 Additional open procedures for postoperative complications Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected
Open in figure viewer Analysis 2.6 Comparison 2 Active drain versus passive drain, Outcome 6 Additional open procedures for postoperative complications.

Open in table viewer

Comparison 3. Early versus late drain removal

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Morbidity Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected
Open in figure viewer Analysis 3.1 Comparison 3 Early versus late drain removal, Outcome 1 Morbidity.
2 Length of hospital stay (days) Show forest plot	1		Mean Difference (IV, Random, 95% CI)	Totals not selected
Open in figure viewer Analysis 3.2 Comparison 3 Early versus late drain removal, Outcome 2 Length of hospital stay (days).
3 Hospital costs (EUR) Show forest plot	1		Mean Difference (IV, Random, 95% CI)	Totals not selected
Open in figure viewer Analysis 3.3 Comparison 3 Early versus late drain removal, Outcome 3 Hospital costs (EUR).
4 Additional open procedures for postoperative complications Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected
Open in figure viewer Analysis 3.4 Comparison 3 Early versus late drain removal, Outcome 4 Additional open procedures for postoperative complications.

Open in table viewer

Comparison 4. Drain use versus no drain use sensitivity analysis for missing data

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Mortality (90 days) ‐ worst‐case scenario Show forest plot	2	536	Risk Ratio (M‐H, Random, 95% CI)	2.15 [0.05, 89.11]
Open in figure viewer Analysis 4.1 Comparison 4 Drain use versus no drain use sensitivity analysis for missing data, Outcome 1 Mortality (90 days) ‐ worst‐case scenario.
2 Mortality (90 days) ‐ best‐case scenario Show forest plot	2	536	Risk Ratio (M‐H, Random, 95% CI)	0.07 [0.00, 1.01]
Open in figure viewer Analysis 4.2 Comparison 4 Drain use versus no drain use sensitivity analysis for missing data, Outcome 2 Mortality (90 days) ‐ best‐case scenario.

Figure 1

Study flow diagram: 2018 review update

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Figure 2

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

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Figure 3

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

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Analysis 1.1

Comparison 1 Drain use versus no drain use, Outcome 1 Mortality (30 days).

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Analysis 1.2

Comparison 1 Drain use versus no drain use, Outcome 2 Mortality (90 days).

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Analysis 1.3

Comparison 1 Drain use versus no drain use, Outcome 3 Intra‐abdominal infection.

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Analysis 1.4

Comparison 1 Drain use versus no drain use, Outcome 4 Wound infection.

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Analysis 1.5

Comparison 1 Drain use versus no drain use, Outcome 5 Morbidity.

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Analysis 1.6

Comparison 1 Drain use versus no drain use, Outcome 6 Length of hospital stay (days).

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Analysis 1.7

Comparison 1 Drain use versus no drain use, Outcome 7 Additional open procedures for postoperative complications.

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Analysis 1.8

Comparison 1 Drain use versus no drain use, Outcome 8 Additional radiological interventions for postoperative complications.

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Analysis 2.1

Comparison 2 Active drain versus passive drain, Outcome 1 Mortality (30 days).

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Analysis 2.2

Comparison 2 Active drain versus passive drain, Outcome 2 Intra‐abdominal infection.

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Analysis 2.3

Comparison 2 Active drain versus passive drain, Outcome 3 Wound infection.

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Analysis 2.4

Comparison 2 Active drain versus passive drain, Outcome 4 Morbidity.

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Analysis 2.5

Comparison 2 Active drain versus passive drain, Outcome 5 Length of hospital stay (days).

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Analysis 2.6

Comparison 2 Active drain versus passive drain, Outcome 6 Additional open procedures for postoperative complications.

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Analysis 3.1

Comparison 3 Early versus late drain removal, Outcome 1 Morbidity.

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Analysis 3.2

Comparison 3 Early versus late drain removal, Outcome 2 Length of hospital stay (days).

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Analysis 3.3

Comparison 3 Early versus late drain removal, Outcome 3 Hospital costs (EUR).

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Analysis 3.4

Comparison 3 Early versus late drain removal, Outcome 4 Additional open procedures for postoperative complications.

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Analysis 4.1

Comparison 4 Drain use versus no drain use sensitivity analysis for missing data, Outcome 1 Mortality (90 days) ‐ worst‐case scenario.

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Analysis 4.2

Comparison 4 Drain use versus no drain use sensitivity analysis for missing data, Outcome 2 Mortality (90 days) ‐ best‐case scenario.

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Summary of findings for the main comparison. Drain use versus no drain use for pancreatic surgery

Drain use versus no drain use for pancreatic surgery
Patient or population: people undergoing elective open pancreatic resections Setting: hospital Intervention: drain use Comparison: no drain use
Outcomes	*Anticipated absolute effects^ (95% CI)**		Relative effect (95% CI)	No of participants (studies)	Certainty of the evidence (GRADE)	Comments
Outcomes	Risk with no drain use	Risk with drain use	Relative effect (95% CI)	No of participants (studies)	Certainty of the evidence (GRADE)	Comments
Mortality Follow‐up: 30 days	23 per 1000	18 per 1000 (7 to 46)	RR 0.78 (0.31 to 1.99)	1055 (4 studies)	⊕⊕⊕⊝ Moderate^1,2
Mortality Follow‐up: 90 days	42 per 1000	10 per 1000 (3 to 38)	RR 0.23 (0.06 to 0.90)	478 (2 studies)	⊕⊕⊕⊝ Moderate^1,2
Intra‐abdominal infection Follow‐up: 30 days	82 per 1000	80 per 1000 (43 to 148)	RR 0.97 (0.52 to 1.80)	1055 (4 studies)	⊕⊝⊝⊝ Very low^1,2,3,4
Wound infection Follow‐up: 30 days	99 per 1000	97 per 1000 (68 to 140)	RR 0.98 (0.68 to 1.41)	1055 (4 studies)	⊕⊕⊝⊝ Low^1,2,3
Drain‐related complications Follow‐up: 30 days	See comment	See comment	Not estimable	179 (1 study)	⊕⊕⊝⊝ Low^1,2,3	There was 1 drain‐related complication in the drainage group. The drainage tube was broken.
Morbidity Follow‐up: 30 days	597 per 1000	614 per 1000 (561 to 674)	RR 1.03 (0.94 to 1.13)	1055 (4 studies)	⊕⊕⊕⊝ Moderate^2,3
Length of hospital stay Follow‐up: 30 days	The mean length of hospital stay in the no drain groups was 13.8 days	The mean length of hospital stay in the drain groups was 0.66 days lower (1.6 lower to 0.29 higher)	MD ‐0.66 (‐1.60 to 0.29)	711 (3 studies)	⊕⊕⊕⊝ Moderate^2,3
Hospital costs Follow‐up: 30 days	Not reported
Additional open procedures for postoperative complications Follow‐up: 30 days	71 per 1000	94 per 1000 (56 to 158)	RR 1.33 (0.79 to 2.23)	1055 (4 studies)	⊕⊕⊝⊝ Low^1,2,3
Additional radiological interventions for postoperative complications Follow‐up: 30 days	121 per 1000	105 per 1000 (48 to 227)	RR 0.87 (0.40 to 1.87)	660 (3 studies)	⊕⊝⊝⊝ Very low^1,2,3,4
Pain Follow‐up: 30 days	Not reported
Quality of life Follow‐up: 30 days FACT‐PA questionnaire: scale 0 to 144, where higher values indicate better quality of life	The mean quality of life score in the no drain group was 104 points	The mean quality of life score in the drain groups was 105 points	Not estimable (see comment)	399 (1 study)	⊕⊕⊝⊝ Low^2,3,5	The study reported the mean quality of life score, without mentioning the standard deviation.
* The basis for the assumed risk was the control group proportion in the study. The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the control group and the relative effect of the intervention (and its 95% CI). CI: Confidence interval; RR: Risk ratio; MD: mean difference.
GRADE Working Group grades of evidence High certainty: We are very confident that the true effect lies close to that of the estimate of the effect Moderate certainty: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different Low certainty: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect Very low certainty: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect
¹ Downgraded one level for serious imprecision (very few events, confidence interval of risk ratio overlapped 0.75 and 1.25). ² Publication bias could not be assessed because of the few number of studies. ³ Downgraded one level for serious risk of bias. ⁴ Downgraded one level for serious heterogeneity. ⁵ Downgraded one level due to serious imprecision (total population size was less than 400).

Summary of findings for the main comparison. Drain use versus no drain use for pancreatic surgery

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Summary of findings 2. Active drain versus passive drain for pancreatic surgery

Active drain versus passive drain for pancreatic surgery
Patient or population: people undergoing elective open pancreatic resections Setting: hospital Intervention: active drain Comparison: passive drain
Outcomes	*Anticipated absolute effects^ (95% CI)**		Relative effect (95% CI)	No of participants (studies)	Quality of the evidence (GRADE)	Comments
Outcomes	Risk with passive drain	Risk with active drain	Relative effect (95% CI)	No of participants (studies)	Quality of the evidence (GRADE)	Comments
Mortality Follow‐up: 30 days	1 per 1000	3 per 1000 (0 to 69)	RR 2.86 (0.12 to 69.06)	160 (1 study)	⊕⊕⊝⊝ Low^1,2	There were no events in the control arm. A risk of "1 per 1000" was chosen for illustration. RR was calculated using a correction factor and should be interpreted with caution.
Mortality Follow‐up: 90 days	Not reported
Intra‐abdominal infection Follow‐up: 30 days	26 per 1000	5 per 1000 (0 to 100)	RR 0.19 (0.01 to 3.90)	160 (1 study)	⊕⊝⊝⊝ Very low^1,2,3
Wound infection Follow‐up: 30 days	90 per 1000	61 per 1000 (21 to 184)	RR 0.68 (0.23 to 2.05)	160 (1 study)	⊕⊝⊝⊝ Very low^1,2,3
Drain‐related complications Follow‐up: 30 days	Not reported
Morbidity Follow‐up: 30 days	321 per 1000	218 per 1000 (131 to 369)	RR 0.68 (0.41 to 1.15)	160 (1 study)	⊕⊕⊝⊝ Low^2,3,4
Length of hospital stay Follow‐up: 30 days	The mean length of hospital stay in the passive drain group was 14.5 days	The mean length of hospital stay in the active drain group was 1.90 days lower (3.67 days to 0.13 days lower)	MD ‐1.90 (‐3.67 to ‐0.13)	160 (1 study)	⊕⊕⊝⊝ Low^2,3,5
Hospital costs Follow‐up: 30 days	Not reported
Additional open procedures for postoperative complications Follow‐up: 30 days	77 per 1000	12 per 1000 (2 to 99)	RR 0.16 (0.02 to 1.29)	160 (1 study)	⊕⊝⊝⊝ Very low^1,2,3
Additional radiological interventions for postoperative complications Follow‐up: 30 days	Not reported
Pain Follow‐up: 30 days	Not reported
Quality of life Follow‐up: 30 days	Not reported
* The basis for the assumed risk was the control group proportion in the study. The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the control group and the relative effect of the intervention (and its 95% CI). CI: confidence interval; MD: mean difference; 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 Downgraded two levels for very serious imprecision (small sample sizes, very few events, confidence intervals of risk ratios overlapped 0.75 and 1.25). ² Publication bias could not be assessed because of the few number of studies. ³ Downgraded one level for serious risk of bias. ⁴ Downgraded one level for serious imprecision (small sample sizes, very few events). ⁵ Downgraded one level due to serious imprecision (total population size was less than 400).

Summary of findings 2. Active drain versus passive drain for pancreatic surgery

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Summary of findings 3. Early versus late drain removal for pancreatic surgery

Early versus late drain removal for pancreatic surgery
Patient or population: people undergoing elective open pancreatic resections Setting: hospital Intervention: early drain removal Comparison: late drain removal
Outcomes	*Anticipated absolute effects^ (95% CI)**		Relative effect (95% CI)	No of participants (studies)	Quality of the evidence (GRADE)	Comments
	Risk with late drain removal	Risk with early drain removal
Mortality Follow‐up: 30 days	There was no mortality in either group.			114 (1 study)	⊕⊕⊕⊝ Moderate^1,2
Mortality Follow‐up: 90 days	Not reported
Intra‐abdominal infection Follow‐up: 30 days	Not reported
Wound infection Follow‐up: 30 days	Not reported
Drain‐related complications Follow‐up: 30 days	Not reported
Morbidity Follow‐up: 30 days	614 per 1000	387 per 1000 (264 to 571)	RR 0.63 (0.43 to 0.93)	114 (1 study)	⊕⊕⊝⊝ Low^1,2,3
Length of hospital stay Follow‐up: 30 days	The mean length of hospital stay in the late removal group was 10.8 days	The mean length of hospital stay in the early removal group was 2.1 days lower (4.17 days to 0.03 days lower)	MD ‐2.10 (‐4.17 to ‐0.03)	114 (1 study)	⊕⊕⊝⊝ Low^1,3,4
Hospital costs Follow‐up: 30 days	The mean hospital costs in the late removal group was EUR 12140.00	The mean hospital costs in the early removal group was EUR 2069 lower (EUR 3872.26 lower to EUR 265.74 lower)	MD ‐2069.00 (‐3872.26 to ‐265.74)	114 (1 study)	⊕⊕⊝⊝ Low^1,3,4
Additional open procedures for postoperative complications Follow‐up: 30 days	18 per 1000	6 per 1000 (0 to 141)	RR 0.33 (0.01 to 8.01)	114 (1 study)	⊕⊝⊝⊝ Very low^1,3,5
Additional radiological interventions for postoperative complications Follow‐up: 30 days	Not reported
Pain Follow‐up: 30 days	Not reported
Quality of life Follow‐up: 30 days	Not reported
* The basis for the assumed risk was the control group proportion in the study. The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the control group and the relative effect of the intervention (and its 95% CI). CI: confidence interval; MD: mean difference; 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 Publication bias could not be assessed because of the few number of studies. ² Downgraded one level for serious imprecision (small sample sizes, very few events). ³ Downgraded one level due to serious risk of bias. ⁴ Downgraded one level due to serious imprecision (total population size was fewer than 400). ⁵ Downgraded two levels for very serious imprecision (small sample sizes, very few events, confidence intervals of risk ratios overlapped 0.75 and 1.25).

Summary of findings 3. Early versus late drain removal for pancreatic surgery

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Comparison 1. Drain use versus no drain use

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Mortality (30 days) Show forest plot	3	711	Risk Ratio (M‐H, Random, 95% CI)	0.78 [0.31, 1.99]

2 Mortality (90 days) Show forest plot	2	478	Risk Ratio (M‐H, Random, 95% CI)	0.23 [0.06, 0.90]

3 Intra‐abdominal infection Show forest plot	4	1055	Risk Ratio (M‐H, Random, 95% CI)	0.97 [0.52, 1.80]

4 Wound infection Show forest plot	4	1055	Risk Ratio (M‐H, Random, 95% CI)	0.98 [0.68, 1.41]

5 Morbidity Show forest plot	4	1055	Risk Ratio (M‐H, Random, 95% CI)	1.03 [0.94, 1.13]

6 Length of hospital stay (days) Show forest plot	3	711	Mean Difference (IV, Random, 95% CI)	‐0.66 [‐1.60, 0.29]

7 Additional open procedures for postoperative complications Show forest plot	4	1055	Risk Ratio (M‐H, Random, 95% CI)	1.33 [0.79, 2.23]

8 Additional radiological interventions for postoperative complications Show forest plot	3	660	Risk Ratio (M‐H, Random, 95% CI)	0.87 [0.40, 1.87]

Comparison 1. Drain use versus no drain use

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Comparison 2. Active drain versus passive drain

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Mortality (30 days) Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

2 Intra‐abdominal infection Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

3 Wound infection Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

4 Morbidity Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

5 Length of hospital stay (days) Show forest plot	1		Mean Difference (IV, Random, 95% CI)	Totals not selected

6 Additional open procedures for postoperative complications Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

Comparison 2. Active drain versus passive drain

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Comparison 3. Early versus late drain removal

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Morbidity Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

2 Length of hospital stay (days) Show forest plot	1		Mean Difference (IV, Random, 95% CI)	Totals not selected

3 Hospital costs (EUR) Show forest plot	1		Mean Difference (IV, Random, 95% CI)	Totals not selected

4 Additional open procedures for postoperative complications Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

Comparison 3. Early versus late drain removal

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Comparison 4. Drain use versus no drain use sensitivity analysis for missing data

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Mortality (90 days) ‐ worst‐case scenario Show forest plot	2	536	Risk Ratio (M‐H, Random, 95% CI)	2.15 [0.05, 89.11]

2 Mortality (90 days) ‐ best‐case scenario Show forest plot	2	536	Risk Ratio (M‐H, Random, 95% CI)	0.07 [0.00, 1.01]

Comparison 4. Drain use versus no drain use sensitivity analysis for missing data

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Referencias

منابع مطالعات واردشده در این مرور

Bassi 2010 {published data only}

Conlon 2001 {published data only}

Jiang 2016 {published data only}

Van Buren 2014 {published data only}

Van Buren 2017 {published data only}

Witzigmann 2016 {published data only}

منابع مطالعات خارج‌شده از این مرور

Adham 2013 {published data only}

Behrman 2015 {published data only}

Correa‐Gallego 2013 {published data only}

Fisher 2011 {published data only}

Giovinazzo 2011 {published data only}

Heslin 1998 {published data only}

Jeekel 1992 {published data only}

Kawai 2006 {published data only}

Kunstman 2017 {published data only}

Lee 2009 {published data only}

Lim 2013 {published data only}

Mehta 2013 {published data only}

Paulus 2012 {published data only}

منابع مطالعات در حال انجام

Čečka 2015 {published data only}

منابع اضافی

Allen 2011

Anderson 2006

Andrén‐Sandberg 2011

Bassi 2017

Bornman 2001

Braganza 2011

Cameron‐Strange 1985

Charoenkwan 2017

Cheng 2014

Cheng 2015

Cheng 2016a

Cheng 2017

Clavien 2009

Connor 2005

Diener 2011

Dindo 2004

Dragovich 2017

Durai 2009

Forman 2011

Garg 2004

Gates 2013

GRADEpro GDT [Computer program]

Gurusamy 2007a

Gurusamy 2007b

Gurusamy 2013a

Gurusamy 2013b

Hackert 2011

Halloran 2002

Henkus 1999

Higgins 2003

Higgins 2011

Hüttner 2017

Inoue 2011

ISRCTN04937707

Kamisawa 2016

Kleeff 2017

Lowenfels 2006

Lévy 2006

Makama 2010

Memon 2001

Moher 2009

NCT00931554

NCT01441492

Nomura 1998

Parker 2007

Reed 1992

Reeves 2011

RevMan 2014 [Computer program]

Rolph 2004

Sahu 2008

Samraj 2007

Spanier 2008

Srivastava 2007