مقایسه بازسازی به روش Roux‐en‐Y در برابر Billroth‐I پس از انجام گاسترکتومی دیستال برای سرطان معده
Referencias
منابع مطالعات واردشده در این مرور
منابع مطالعات خارجشده از این مرور
منابع مطالعات در انتظار ارزیابی
منابع اضافی
Characteristics of studies
Characteristics of included studies [ordered by study ID]
| Study characteristics | ||
| Methods | RCT, single‐centre, Seoul, South Korea Aim: "To investigate the impact of RY in distal gastrectomy, which can provide a longer bypass length of the proximal jejunum than BI and BII" Inclusion period: 35 months, from July 2011 to May 2014 Timing of randomisation: before surgery Registered ID: NCT01375738 | |
| Participants | Number randomised: 44 Age: 20 to 80 Inclusion criteria: patients diagnosed with early gastric cancer and type 2 diabetes mellitus Exclusion criteria:
Stage: all participants were diagnosed as cT1N0 preoperatively, and stage IV patients were not included. | |
| Interventions | Roux‐en‐Y vs Billroth‐I Devices: linear staplers were used in each group. Approach: all participants underwent laparoscopic surgery. | |
| Outcomes | Primary outcome: blood sugar stabilisation after gastrectomy at 3 months after surgery by comparing the difference between fasting blood sugar and postprandial blood glucose, blood sugar stabilisation after gastrectomy. Questionnaire for quality of life was listed as 1 of the outcomes in a translated protocol attached to the article. | |
| Notes | All participants received diabetic medication. Funding source was not stated; 1 of the authors acquired some funding, however the relationship of the funder to the author was unclear. Conflict of interest: the authors have declared that no competing interests existed. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "computer‐generated randomisation" Comment: done |
| Allocation concealment (selection bias) | Unclear risk | Comment: not mentioned |
| Blinding of participants and personnel (performance bias) | High risk | Quote: "Neither patients nor investigators were masked to treatment assignment" |
| Blinding of outcome assessment (detection bias) | High risk | Comment: participants were not blinded for the outcome health‐related quality of life. |
| Incomplete outcome data (attrition bias) | Low risk | Comment: there were 2/22 (9.1%) cases of loss to follow‐up in each group according to adjuvant chemotherapy, but numbers were balanced. |
| Selective reporting (reporting bias) | High risk | Comment: the study was registered before enrolment, but the prespecified outcome of quality of life was not reported. |
| Other bias | High risk | Comment: there is an unreported alteration for the timing of primary endpoint measure. Timing of randomisation was before surgery. |
| Study characteristics | ||
| Methods | RCT, single‐centre, Rome, Italy Aim: to evaluate which of the 3 techniques guarantees the best functional results Inclusion period: between 1990 and 1995 Allocation: 3 arms Timing of randomisation: no information provided. | |
| Participants | Number randomised: 45 Age: not mentioned as inclusion criteria (observed range: 39 to 77) Inclusion criteria: benign diseases (whether peptic or duodenal ulcer) and malignant tumours in early stages (gastric carcinoma) Exclusion criteria: not mentioned Stage: amongst 45 participants analysed, 25 participants (55%) had benign diseases and 20 participants (45%) had early gastric carcinoma. | |
| Interventions | Roux‐en‐Y vs Billroth‐I vs Billroth‐II | |
| Outcomes | Gastro‐oesophageal reflux, dynamics of gastric emptying, and quality of life (GIQLI) | |
| Notes | Funding source: not mentioned Declaration of interests: no information provided. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Quote: "Randomizzato e stratificato" and "patients were assigned randomly to 3 homogenous clusters" Comment: no further information provided. |
| Allocation concealment (selection bias) | Unclear risk | Comment: not mentioned |
| Blinding of participants and personnel (performance bias) | High risk | Comment: not mentioned in the study reports, but it is theoretically impossible for surgeons to perform reconstruction without knowing the allocation |
| Blinding of outcome assessment (detection bias) | Unclear risk | Comment: not mentioned |
| Incomplete outcome data (attrition bias) | Unclear risk | Comment: missing participants were not described for quality of life. |
| Selective reporting (reporting bias) | Unclear risk | Comment: no information about study registration |
| Other bias | Unclear risk | Comment: insufficient information provided. |
| Study characteristics | ||
| Methods | RCT, single‐centre, Suwon, South Korea Aim: to assess the effect of R‐Y reconstruction on bile reflux as objectively as possible Inclusion period: 17 months, from July 2010 to November 2011 Allocation: parallel Timing of randomisation: before surgery Registered ID: NCT01142271 | |
| Participants | Number randomised: 118 Age: 25 to 74 Inclusion criteria: patients with gastric adenocarcinoma located in the middle or distal portion of the stomach Exclusion criteria: pregnancy, synchronous malignancy, and uncontrolled systemic disease Stage: amongst 114 participants analysed, 99 participants (86.8%) were in stage I. Stage IV patients were not included. | |
| Interventions | Roux‐en‐Y vs Billroth‐I Devices: circular staplers (29 mm in diameter) were used in each group. Approach: 91.4% and 87.5% of participants underwent laparoscopic resection in Roux‐en‐Y and Billroth‐I groups, respectively. | |
| Outcomes | Primary endpoint: reflux of bile content 6 months after surgery Secondary outcomes:
| |
| Notes | Funding source: a grant from the National R&D Program for Cancer Control, Ministry of Health and Welfare, Republic of Korea (1320270) Declaration of interests: no potential conflicts of interest reported. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Comment: the method of randomisation was not described. |
| Allocation concealment (selection bias) | Unclear risk | Comment: the method of concealment was not described. |
| Blinding of participants and personnel (performance bias) | High risk | Quote: "Surgeons and patients were not blinded" |
| Blinding of outcome assessment (detection bias) | High risk | Quote: "Investigators and data collectors were blinded" Comment: however, the outcome HRQoL was judged to be at high risk of bias because participants were not blinded. |
| Incomplete outcome data (attrition bias) | Unclear risk | Comment: follow‐up rates between intervention groups were imbalanced, and the reasons for missing data were described only as "lost to follow‐up". |
| Selective reporting (reporting bias) | Low risk | Comment: the study was registered before enrolment, and the prespecified outcomes were reported. |
| Other bias | High risk | Comment: timing of randomisation was before surgery, which may have influenced the procedure. |
| Study characteristics | ||
| Methods | RCT, single‐centre, Tokyo, Japan Aim: "To determine the clinical efficacy of Roux‐en‐Y reconstruction (RY) after distal gastrectomy" Inclusion period: 45 months, from January 2001 to September 2004 Allocation: parallel Timing of randomisation: preoperatively | |
| Participants | Number randomised: 50 Age: not clearly mentioned Inclusion criteria: patients who underwent distal gastrectomy for gastric cancer Exclusion criteria: not mentioned Stage: amongst 50 participants analysed, 23 participants (46%) were in stage I, and 1 participant (2.0%) was in stage IV. | |
| Interventions | Roux‐en‐Y vs Billroth‐I Devices: a circular stapler (28 mm in diameter) was used in Roux‐en‐Y group, and hand‐sewn suture (Gambee fashion) was done in Billroth‐I group. Approach: not mentioned | |
| Outcomes | Complications, intraoperative and postoperative course, postoperative nutritional status, and follow‐up endoscopy were evaluated. | |
| Notes | Funding source: not mentioned Declaration of interests: no information provided. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Quote: "Randomized preoperatively" Comment: no further information provided. |
| Allocation concealment (selection bias) | Unclear risk | Quote: "sealed envelop" Comment: no further information about opacity provided. |
| Blinding of participants and personnel (performance bias) | High risk | Comment: not mentioned in the study report, but it is theoretically impossible for surgeons to perform reconstruction without knowing the allocation |
| Blinding of outcome assessment (detection bias) | Unclear risk | Comment: no information provided. |
| Incomplete outcome data (attrition bias) | Low risk | Comment: the proportion of missing participants was low. |
| Selective reporting (reporting bias) | Unclear risk | Comment: not registered |
| Other bias | High risk | Comment: intraoperative randomisation was not employed. |
| Study characteristics | ||
| Methods | RCT, single‐centre, Seongnam, South Korea Aim: "To evaluate what is the best reconstruction method after distal gastrectomy" Inclusion period: March 2006 to August 2007 Allocation: 3 arms Timing of randomisation: not mentioned | |
| Participants | Number randomised: 159 Age: not mentioned as inclusion criteria Inclusion criteria: patients who were diagnosed preoperatively with distal gastric cancer and who underwent curative resection Exclusion criteria: duodenal invasion, gastric outlet obstruction, or the possibility of excessive tension on the anastomotic site, all conditions that precluded the possibility of performing the Billroth I procedure Stage: no information provided. | |
| Interventions | Roux‐en‐Y vs Billroth‐I vs Billroth‐II Devices: a circular stapler (25 mm in diameter) was used in Billroth‐I group, and hand‐sewn suture was done in Roux‐en‐Y group. Approach: amongst 149 participants analysed, 75 participants (50%) underwent laparoscopic surgery. Amongst 96 participants who were allocated to R‐Y or B‐I groups and analysed, 50 participants (52%) underwent laparoscopic surgery. | |
| Outcomes | Primary endpoint: incidence of bile reflux according to reconstructive type after gastrectomy Secondary endpoint: differences in postoperative QoL and nutritional status of participants according to reconstruction type | |
| Notes | Funding source: the study was supported by grant 02‐2006‐021 from Seoul National University Bundang Hospital. Declaration of interests: all authors declared that they had no conflicts of interest or financial ties to disclose. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "Group allocation was determined by a computer‐generated random table" |
| Allocation concealment (selection bias) | Unclear risk | Comment: not mentioned |
| Blinding of participants and personnel (performance bias) | High risk | Quote: "The patient was also blinded to the type of operation performed" |
| Blinding of outcome assessment (detection bias) | High risk | Quote: "All medical documents were recorded without specifying the actual surgical approach" Comment: participants were blinded in answering patient‐reported outcome. However, it would seem to be impossible to make medical records whilst concealing the procedures actually performed (generally surgeons make surgical records). The blinding could have been broken, and the outcome measurement was likely to be influenced by lack of blinding. |
| Incomplete outcome data (attrition bias) | Unclear risk | Comment: missing participants, and the reasons for the missing data were not clearly described; also, the analysed number of participants was not mentioned for some outcomes. |
| Selective reporting (reporting bias) | Unclear risk | Comment: the study was not registered before enrolment, and prespecified outcomes were unclear. |
| Other bias | Unclear risk | Comment: no information on the timing of randomisation |
| Study characteristics | ||
| Methods | RCT, multicentre, Wakayama, Japan Publication type: full report Aim: to investigate the optimal procedure for reconstruction after distal gastrectomy in patients who had a Billroth I or Roux‐en‐Y procedure, with respect to long‐term QoL Inclusion period: from January 2009 to September 2010 Allocation: parallel Timing of randomisation: intraoperatively Registered ID: NCT01065688 | |
| Participants | Number randomised: 122 Age: 20 to 80 years Inclusion criteria:
Exclusion criteria:
Stage: amongst 122 participants randomised, 89 participants (73%) were in Stage IA or IB. Stage IV patients were not included. | |
| Interventions | Roux‐en‐Y vs Billroth‐I Devices: circular stapling devices were used in both group for anastomosis. Approach: amongst 122 participants randomised, 50 participants (41%) underwent laparoscopic resection. | |
| Outcomes | Primary endpoint: FACT‐Ga total score at 36 months after surgery Secondary endpoints:
| |
| Notes | Funding source: no information provided. Declaration of interests: the authors declared no conflict of interest. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "Computer‐generated random number pattern (block size 4)" |
| Allocation concealment (selection bias) | Low risk | Quote: "Central allocation by telephone" |
| Blinding of participants and personnel (performance bias) | High risk | Quote: "Patients were not blinded for the type of reconstruction" Comment: surgeons and participants were not blinded. |
| Blinding of outcome assessment (detection bias) | High risk | Quote: "All data on postoperative outcomes were collected by a trained coordinator and discussed by at least three surgeons, who were not blinded to the allocation" Comment: quality of life was reported by participants, who were not blinded. |
| Incomplete outcome data (attrition bias) | Unclear risk | Comment: missing participants for the outcome QoL were well balanced, although reasons for missing data were not clearly stated. |
| Selective reporting (reporting bias) | Low risk | Comment: this study was registered before enrolment, and the prespecified outcomes were reported. |
| Other bias | Low risk | Comment: there was no concern about other bias. |
| Study characteristics | ||
| Methods | RCT, multicentre, Osaka, Japan Aim: "to evaluate QOL and dysfunction following B‐I and R‐Y reconstructions after distal gastrectomy" Inclusion period: between August 2005 and December 2008 Allocation: parallel Timing of randomisation: intraoperatively | |
| Participants | Number randomised: 332 Age: 20 to 90 years Inclusion criteria: histologically proven gastric cancer, ECOG performance status 0 to 1, and a lack of non‐curative surgical factors except for positive lavage of laparotomy Exclusion criteria: history of laparotomy, interstitial pneumonia, or pulmonary fibrosis, severe heart disease, liver cirrhosis or active hepatitis, chronic renal failure, severe diabetes (glycated haemoglobin >= 9.0%), severe reflux oesophagitis Stage: amongst 332 participants randomised, 263 participants (79%) were stage IA or IB. 5 participants (1.5%) were stage IV. | |
| Interventions | Roux‐en‐Y vs Billroth‐I Devices: hand‐sewn and automatic sutures were not regulated in this study. Approach: amongst 332 participants randomised, 62 participants (18.7%) underwent laparoscopic surgery. | |
| Outcomes |
| |
| Notes | Funding source: self‐funding (from registration data) | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "Minimaization method" Comment: probably done |
| Allocation concealment (selection bias) | Low risk | Quote: "At the data centre at Osaka Unviersity" Comment: central registration |
| Blinding of participants and personnel (performance bias) | High risk | Comment: not mentioned in the study reports, but it would be theoretically impossible for surgeons to perform reconstruction without knowing the allocation |
| Blinding of outcome assessment (detection bias) | Unclear risk | Comment: no information provided. |
| Incomplete outcome data (attrition bias) | Unclear risk | Comment: missing data were balanced between groups, but the reasons for attrition were not clearly reported, although reasons for exclusion were described. |
| Selective reporting (reporting bias) | Low risk | Comment: all the expected outcomes including every domain of QoL were reported. |
| Other bias | High risk | Comment: baseline imbalances may influence the outcome, as all 5 participants with stage IV disease were included in the Roux‐en‐Y group. |
| Study characteristics | ||
| Methods | RCT, single‐centre, Chengdu, China Aim: to compare the quality of life of patients undergoing Billroth‐I versus Roux‐en‐Y reconstruction after curative distal gastrectomy for gastric cancer Inclusion period: 37 months: May 2011 to May 2014 Allocation: parallel Timing of randomisation: intraoperatively Registered ID: ChiCTR‐TRC‐10001434 | |
| Participants | Number randomised: 140 Age: 20 to 80 years Inclusion criteria: patients with gastric adenocarcinoma with stages less than T4aN2M0 were included. The tumours were located at the lower third of stomach. Exclusion criteria: total gastrectomy, combined organ resection (except cholecystectomy), lymphoma or GIST, previous or synchronous malignancies, emergency cases, and neoadjuvant chemotherapy or radiotherapy Stage: amongst 140 participants randomised, 52 participants (37.1%) were in stage I and 7 participants (5.0%) were in stage IV. | |
| Interventions | Roux‐en‐Y vs Billroth‐I Devices: circular staplers (25 mm in diameter) were used in each group. A total of 36 participants (25.7%) underwent laparoscopic resection. Approach: amongst 140 participants randomised, 36 participants (25.7%) underwent laparoscopic resection. | |
| Outcomes | Primary endpoint: QoL (EORTC QLQ‐C30, EORTC QLQ‐STO22) Secondary endpoint: mortality, complication, and severity of postoperative gastritis | |
| Notes | Funding source: (1) National Natural Science Foundation of China (No. 81301867, 81372344); (2) Sichuan Province Youth Science & Technology Innovative Research Team (No. 2015TD0009); (3) 1. 3. 5 project for disciplines of excellence, West China Hospital, Sichuan University; (4) Te Scientific Research Program of Public Health Department of Sichuan Province, China (No. 120196) | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "random number table" |
| Allocation concealment (selection bias) | Low risk | Quote: "sealed in opaque envelop" Comment: probably done |
| Blinding of participants and personnel (performance bias) | High risk | Quote: "patients, surgeons, staffs who collected data and analysed outcomes were not blinded" |
| Blinding of outcome assessment (detection bias) | High risk | Quote: "Patients, surgeons, staffs who collected data and analysed outcomes were not blinded" Comment: patient‐reported outcome is at high risk of bias. |
| Incomplete outcome data (attrition bias) | Unclear risk | Comment: missing outcome data were balanced, but 34% of participants were lost in assessment of bile reflux, with no reasons provided. |
| Selective reporting (reporting bias) | Low risk | Comment: the study was registered before enrolment, and the prespecified outcomes were reported. |
| Other bias | High risk | Comment: imbalance in the proportion of participants who underwent postoperative chemotherapy may affect the outcome. |
BI: Billroth‐I
BII: Billroth‐II
BMI: body mass index
DAUGS20: Dysfunction After Upper Gastrointestinal Surgery 20
ECOG: Eastern Cooperative Oncology Group
EORTC QLQ‐C30: EORTC Core Quality of Life Questionnaire ‐ Core Questionnaire
EORTC QLQ‐STO22: EORTC Quality of Life Questionnaire ‐ Gastric Cancer Module
FACT‐Ga: Functional Assessment of Cancer Therapy‐Gastric
GIQLI: Gastrointestinal Quality of Life Index
GIST: gastrointestinal stromal tumour
HRQoL: health‐related quality of life
QoL: quality of life
RCT: randomised controlled trial
R‐Y: Roux‐en‐Y
Characteristics of excluded studies [ordered by study ID]
| Study | Reason for exclusion |
| Randomisation process was conditional. | |
| Randomisation process was conditional. |
Characteristics of studies awaiting classification [ordered by study ID]
| Methods | RCT, single‐centre, Wuhan, China Aim: to explore the efficacy of delta‐shaped Billroth‐I anastomosis in totally laparoscopic distal gastrectomy for digestive tract reconstruction Inclusion period: unknown Allocation: parallel Timing of randomisation: unknown Registered ID: unknown |
| Participants | Number randomised: 180 Age: not stated Inclusion criteria:
Exclusion criteria: preoperative chemotherapy or radiotherapy, patients with other severe liver or kidney dysfunction, and distant metastasis Stage: not reported |
| Interventions | Roux‐en‐Y vs Billroth‐I vs Billroth‐II Devices: delta‐shaped anastomosis using linear staplers was employed in Billroth‐I group. Hand‐sewn or using staplers was not regulated in Roux‐en‐Y group. Length from Treitz ligament to jejunojejunostomy was 15 cm, whilst length from jejunojejunostomy to gastrojejunostomy was approximately 50 cm. Approach: all participants underwent laparoscopic surgery. |
| Outcomes | Prespecified endpoints were not stated. Reported outcomes were as follows: length of hospital stay, operation time, volume of lymphatic drainage, intraoperative blood loss, time to anal exsufflation, hospitalisation length, distance between the proximal margin and the lesion, distance between the distal margin and the lesion, haemoglobin, pre‐albumin, total plasma protein, CD4, CD8, the CD4/CD8 ratio, incidence of postoperative infection, intestinal obstruction, anastomotic fistula, and reflux gastritis. |
| Notes | Study protocol was unavailable. The study was approved by the Institutional Review Board of the Ethics Committee in 2016. |
Data and analyses
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 1.1 Health‐related quality of life Show forest plot | 6 | 695 | Std. Mean Difference (IV, Random, 95% CI) | 0.04 [‐0.11, 0.18] |
| Analysis 1.1  Comparison 1: Roux‐en‐Y versus Billroth‐I reconstruction, Outcome 1: Health‐related quality of life | ||||
| 1.2 Incidence of anastomotic leakage Show forest plot | 5 | 711 | Risk Ratio (M‐H, Random, 95% CI) | 0.63 [0.16, 2.53] |
| Analysis 1.2  Comparison 1: Roux‐en‐Y versus Billroth‐I reconstruction, Outcome 2: Incidence of anastomotic leakage | ||||
| 1.3 Loss of body weight Show forest plot | 4 | 541 | Mean Difference (IV, Random, 95% CI) | 0.41 [‐0.77, 1.59] |
| Analysis 1.3  Comparison 1: Roux‐en‐Y versus Billroth‐I reconstruction, Outcome 3: Loss of body weight | ||||
| 1.4 Incidence of bile reflux Show forest plot | 4 | 399 | Risk Ratio (M‐H, Random, 95% CI) | 0.40 [0.25, 0.63] |
| Analysis 1.4  Comparison 1: Roux‐en‐Y versus Billroth‐I reconstruction, Outcome 4: Incidence of bile reflux | ||||
| 1.5 Length of hospital stay Show forest plot | 7 | 894 | Mean Difference (IV, Random, 95% CI) | 0.96 [0.16, 1.76] |
| Analysis 1.5  Comparison 1: Roux‐en‐Y versus Billroth‐I reconstruction, Outcome 5: Length of hospital stay | ||||
| 1.6 Postoperative morbidity Show forest plot | 7 | 891 | Risk Ratio (M‐H, Random, 95% CI) | 1.47 [1.02, 2.11] |
| Analysis 1.6  Comparison 1: Roux‐en‐Y versus Billroth‐I reconstruction, Outcome 6: Postoperative morbidity | ||||
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 2.1 Health‐related quality of life based on surgical approach Show forest plot | 6 | 695 | Std. Mean Difference (IV, Random, 95% CI) | 0.04 [‐0.11, 0.18] |
| Analysis 2.1  Comparison 2: Subgroup analysis in Roux‐en‐Y versus Billroth‐I reconstruction, Outcome 1: Health‐related quality of life based on surgical approach | ||||
| 2.1.1 Open studies | 2 | 404 | Std. Mean Difference (IV, Random, 95% CI) | 0.15 [‐0.05, 0.34] |
| 2.1.2 Laparoscopic studies | 1 | 106 | Std. Mean Difference (IV, Random, 95% CI) | ‐0.21 [‐0.59, 0.17] |
| 2.1.3 Mixed and unknown studies | 3 | 185 | Std. Mean Difference (IV, Random, 95% CI) | ‐0.07 [‐0.35, 0.22] |
| 2.2 Loss of body weight based on surgical approach Show forest plot | 4 | 541 | Mean Difference (IV, Random, 95% CI) | 0.41 [‐0.77, 1.59] |
| Analysis 2.2  Comparison 2: Subgroup analysis in Roux‐en‐Y versus Billroth‐I reconstruction, Outcome 2: Loss of body weight based on surgical approach | ||||
| 2.2.1 Open studies | 1 | 332 | Mean Difference (IV, Random, 95% CI) | 0.60 [‐0.87, 2.07] |
| 2.2.2 Laparoscopic studies | 1 | 40 | Mean Difference (IV, Random, 95% CI) | ‐0.70 [‐4.48, 3.08] |
| 2.2.3 Mixed and unknown studies | 2 | 169 | Mean Difference (IV, Random, 95% CI) | 0.34 [‐2.01, 2.68] |
| 2.3 Health‐related quality of life based on cancer stage Show forest plot | 6 | 695 | Std. Mean Difference (IV, Random, 95% CI) | 0.04 [‐0.11, 0.18] |
| Analysis 2.3  Comparison 2: Subgroup analysis in Roux‐en‐Y versus Billroth‐I reconstruction, Outcome 3: Health‐related quality of life based on cancer stage | ||||
| 2.3.1 Early stage studies | 3 | 490 | Std. Mean Difference (IV, Random, 95% CI) | ‐0.02 [‐0.20, 0.17] |
| 2.3.2 Mixed and unknown studies | 3 | 205 | Std. Mean Difference (IV, Random, 95% CI) | 0.15 [‐0.13, 0.42] |
| 2.4 Loss of body weight based on cancer stage Show forest plot | 4 | 541 | Mean Difference (IV, Random, 95% CI) | 0.41 [‐0.77, 1.59] |
| Analysis 2.4  Comparison 2: Subgroup analysis in Roux‐en‐Y versus Billroth‐I reconstruction, Outcome 4: Loss of body weight based on cancer stage | ||||
| 2.4.1 Early stage studies | 3 | 491 | Mean Difference (IV, Random, 95% CI) | 0.37 [‐0.86, 1.59] |
| 2.4.2 Mixed and unknown studies | 1 | 50 | Mean Difference (IV, Random, 95% CI) | 0.90 [‐3.43, 5.23] |
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 3.1 Length of hospital stay in studies without skewed data Show forest plot | 5 | 722 | Mean Difference (IV, Random, 95% CI) | 0.62 [0.16, 1.09] |
| Analysis 3.1  Comparison 3: Sensitivity analysis in Roux‐en‐Y versus Billroth‐I reconstruction, Outcome 1: Length of hospital stay in studies without skewed data | ||||
| 3.2 Postoperative morbidity in studies in which use of Clavien‐Dindo classification was not unclear Show forest plot | 5 | 463 | Risk Ratio (M‐H, Random, 95% CI) | 1.39 [0.87, 2.24] |
| Analysis 3.2  Comparison 3: Sensitivity analysis in Roux‐en‐Y versus Billroth‐I reconstruction, Outcome 2: Postoperative morbidity in studies in which use of Clavien‐Dindo classification was not unclear | ||||
| 3.3 Incidence of anastomotic leakage with a fixed‐effect model Show forest plot | 5 | 711 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.61 [0.19, 1.93] |
| Analysis 3.3  Comparison 3: Sensitivity analysis in Roux‐en‐Y versus Billroth‐I reconstruction, Outcome 3: Incidence of anastomotic leakage with a fixed‐effect model | ||||
| 3.4 Health‐related quality of life in studies without benign disease patients Show forest plot | 5 | 665 | Std. Mean Difference (IV, Random, 95% CI) | 0.04 [‐0.12, 0.19] |
| Analysis 3.4  Comparison 3: Sensitivity analysis in Roux‐en‐Y versus Billroth‐I reconstruction, Outcome 4: Health‐related quality of life in studies without benign disease patients | ||||
| 3.5 Loss of body weight in studies not limited to diabetic patients Show forest plot | 3 | 501 | Mean Difference (IV, Random, 95% CI) | 0.53 [‐0.72, 1.77] |
| Analysis 3.5  Comparison 3: Sensitivity analysis in Roux‐en‐Y versus Billroth‐I reconstruction, Outcome 5: Loss of body weight in studies not limited to diabetic patients | ||||
| 3.6 Health‐related quality of life in studies without co‐intervention bias Show forest plot | 5 | 559 | Std. Mean Difference (IV, Random, 95% CI) | ‐0.01 [‐0.18, 0.15] |
| Analysis 3.6  Comparison 3: Sensitivity analysis in Roux‐en‐Y versus Billroth‐I reconstruction, Outcome 6: Health‐related quality of life in studies without co‐intervention bias | ||||
Study flow diagram.
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.
Forest plot of comparison: 1 Roux‐en‐Y versus Billroth‐I reconstruction, outcome: 1.1 Health‐related quality of life.
Forest plot of comparison: 1 Roux‐en‐Y versus Billroth‐I reconstruction, outcome: 1.2 Incidence of anastomotic leakage.
Forest plot of comparison: 1 Roux‐en‐Y versus Billroth‐I reconstruction, outcome: 1.3 Loss of body weight.
Comparison 1: Roux‐en‐Y versus Billroth‐I reconstruction, Outcome 1: Health‐related quality of life
Comparison 1: Roux‐en‐Y versus Billroth‐I reconstruction, Outcome 2: Incidence of anastomotic leakage
Comparison 1: Roux‐en‐Y versus Billroth‐I reconstruction, Outcome 3: Loss of body weight
Comparison 1: Roux‐en‐Y versus Billroth‐I reconstruction, Outcome 4: Incidence of bile reflux
Comparison 1: Roux‐en‐Y versus Billroth‐I reconstruction, Outcome 5: Length of hospital stay
Comparison 1: Roux‐en‐Y versus Billroth‐I reconstruction, Outcome 6: Postoperative morbidity
Comparison 2: Subgroup analysis in Roux‐en‐Y versus Billroth‐I reconstruction, Outcome 1: Health‐related quality of life based on surgical approach
Comparison 2: Subgroup analysis in Roux‐en‐Y versus Billroth‐I reconstruction, Outcome 2: Loss of body weight based on surgical approach
Comparison 2: Subgroup analysis in Roux‐en‐Y versus Billroth‐I reconstruction, Outcome 3: Health‐related quality of life based on cancer stage
Comparison 2: Subgroup analysis in Roux‐en‐Y versus Billroth‐I reconstruction, Outcome 4: Loss of body weight based on cancer stage
Comparison 3: Sensitivity analysis in Roux‐en‐Y versus Billroth‐I reconstruction, Outcome 1: Length of hospital stay in studies without skewed data
Comparison 3: Sensitivity analysis in Roux‐en‐Y versus Billroth‐I reconstruction, Outcome 2: Postoperative morbidity in studies in which use of Clavien‐Dindo classification was not unclear
Comparison 3: Sensitivity analysis in Roux‐en‐Y versus Billroth‐I reconstruction, Outcome 3: Incidence of anastomotic leakage with a fixed‐effect model
Comparison 3: Sensitivity analysis in Roux‐en‐Y versus Billroth‐I reconstruction, Outcome 4: Health‐related quality of life in studies without benign disease patients
Comparison 3: Sensitivity analysis in Roux‐en‐Y versus Billroth‐I reconstruction, Outcome 5: Loss of body weight in studies not limited to diabetic patients
Comparison 3: Sensitivity analysis in Roux‐en‐Y versus Billroth‐I reconstruction, Outcome 6: Health‐related quality of life in studies without co‐intervention bias
| Roux‐en‐Y compared to Billroth‐I after distal gastrectomy for gastric cancer | ||||||
| Patient or population: people undergoing distal gastrectomy for gastric cancer | ||||||
| Outcomes | Anticipated absolute effects* (95% CI) | Relative effect | № of participants | Certainty of the evidence | Comments | |
|---|---|---|---|---|---|---|
| Risk with Billroth‐I | Risk with Roux‐en‐Y | |||||
| Health‐related quality of life | ‐ | SMD 0.04 higher | ‐ | 695 | ⊕⊕⊝⊝ | Regarding the effect size of the SMD, 0.2 represents a small effect, 0.5 a moderate effect, and 0.8 a large effect (Cohen 1988). Converting an SMD of 0.04 into a global health status score of EORTC QLQ‐C30, Roux‐en‐Y may increase it by 0.56 points (95% CI −1.53 to 2.50) (Murad 2019). |
| Incidence of anastomotic leakage | 14 per 1000 | 9 per 1000 | RR 0.63 | 711 | ⊕⊝⊝⊝ | |
| Loss of body weight | The mean loss of body weight ranged from 8 to 9 percent. | The mean loss of body weight was 0.41% greater | ‐ | 541 | ⊕⊕⊝⊝ | Loss of body weight is expressed as a percentage (e.g. if a person of 50 kg becomes 40 kg, the loss of body weight is 20%). Weight loss can theoretically range from negative infinity to 100%, but weight gain is uncommon after gastrectomy, and weight loss of more than 50% is also uncommon. The observed values are therefore usually expected to fall within the range of 0 to 50%. |
| Incidence of bile reflux | 397 per 1000 | 159 per 1000 | RR 0.40 | 399 | ⊕⊕⊕⊝ | |
| Length of hospital stay | The mean length of hospital stay ranged from 7 to 23 days. | The mean length of hospital stay was 0.96 days longer | ‐ | 894 | ⊕⊝⊝⊝ | Length of hospital stay is expressed in days, and ranges from 1 to infinite. |
| Postoperative morbidity | 99 per 1000 | 146 per 1000 | RR 1.47 | 891 | ⊕⊕⊝⊝ | |
| *The risk in the intervention group (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; EORTC QLQ‐C30: EORTC Core Quality of Life Questionnaire ‐ Core Questionnaire; RCT: randomised controlled trial; RR: risk ratio; SMD: standardised mean difference | ||||||
| GRADE Working Group grades of evidence | ||||||
| 1Downgraded one level due to imprecision; 95% CIs are compatible with both benefit and harm. | ||||||
| Study | Roux‐en‐Y | Affected participants in Roux‐en‐Y | Billroth‐I | Affected participants in Billroth‐I |
|---|---|---|---|---|
| 1 Atelectasis 1 Bleeding | 2/20 | 1 Atelectasis 1 Complicated fluid | 2/20 | |
| 3 Postoperative ileus 1 Pneumonia 1 Leakage 1 Wound seroma 1 Voiding difficulty | 6/58 | 1 Postoperative ileus 1 Pneumonia 1 Intra‐abdominal fluid 1 Cholecystitis 1 Voiding difficulty 2 Unknown fever | 7/56 | |
| 10 Pulmonary complications 1 Acute cholecystitis 2 Superficial surgical site infection 2 Intra‐abdominal infection 1 Adhesive ileus 1 Acute urinary retention 1 Gastroplegia | 14/70 | 10 Pulmonary complications 1 Acute cholecystitis 1 Acute urinary retention 1 Gastroplegia | 11/70 | |
| 4 Delayed gastric emptying 1 Pancreatic fistula 2 Anastomotic stricture 1 Pancreatic fistula 1 Postoperative bleeding | 9/59 | 1 Surgical site infection 2 Anastomotic leakage 1 Anastomotic stricture | 4/60 | |
| 1 Anastomotic leakage 2 Gastorojejunostomy outlet obstruction 2 Intra‐abdominal abscess 1 Deep vein thrombosis | 6/47 | 2 Bleeding 1 Wound problem 1 Chyle leakage | 4/49 | |
| 3 Pancreatic fistula 3 Abdominal abscess 2 Bowel obstruction 2 Postoperative pancreatitis 2 Surgical site infection 2 Anastomotic stricture | 23/169 | 2 Pancreatic fistula 2 Anastomotic leakage 3 Abdominal abscess 1 Bowel obstruction 2 Postoperative pancreatitis 3 Surgical site infection 3 Anastomotic stricture | 14/163 | |
| 3 Gastric stasis 1 Intestinal obstruction 1 Pneumonia 2 Anastomotic stricture | 6/24 | 1 Leakage 1 Intestinal obstruction | 2/26 |
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 1.1 Health‐related quality of life Show forest plot | 6 | 695 | Std. Mean Difference (IV, Random, 95% CI) | 0.04 [‐0.11, 0.18] |
| 1.2 Incidence of anastomotic leakage Show forest plot | 5 | 711 | Risk Ratio (M‐H, Random, 95% CI) | 0.63 [0.16, 2.53] |
| 1.3 Loss of body weight Show forest plot | 4 | 541 | Mean Difference (IV, Random, 95% CI) | 0.41 [‐0.77, 1.59] |
| 1.4 Incidence of bile reflux Show forest plot | 4 | 399 | Risk Ratio (M‐H, Random, 95% CI) | 0.40 [0.25, 0.63] |
| 1.5 Length of hospital stay Show forest plot | 7 | 894 | Mean Difference (IV, Random, 95% CI) | 0.96 [0.16, 1.76] |
| 1.6 Postoperative morbidity Show forest plot | 7 | 891 | Risk Ratio (M‐H, Random, 95% CI) | 1.47 [1.02, 2.11] |
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 2.1 Health‐related quality of life based on surgical approach Show forest plot | 6 | 695 | Std. Mean Difference (IV, Random, 95% CI) | 0.04 [‐0.11, 0.18] |
| 2.1.1 Open studies | 2 | 404 | Std. Mean Difference (IV, Random, 95% CI) | 0.15 [‐0.05, 0.34] |
| 2.1.2 Laparoscopic studies | 1 | 106 | Std. Mean Difference (IV, Random, 95% CI) | ‐0.21 [‐0.59, 0.17] |
| 2.1.3 Mixed and unknown studies | 3 | 185 | Std. Mean Difference (IV, Random, 95% CI) | ‐0.07 [‐0.35, 0.22] |
| 2.2 Loss of body weight based on surgical approach Show forest plot | 4 | 541 | Mean Difference (IV, Random, 95% CI) | 0.41 [‐0.77, 1.59] |
| 2.2.1 Open studies | 1 | 332 | Mean Difference (IV, Random, 95% CI) | 0.60 [‐0.87, 2.07] |
| 2.2.2 Laparoscopic studies | 1 | 40 | Mean Difference (IV, Random, 95% CI) | ‐0.70 [‐4.48, 3.08] |
| 2.2.3 Mixed and unknown studies | 2 | 169 | Mean Difference (IV, Random, 95% CI) | 0.34 [‐2.01, 2.68] |
| 2.3 Health‐related quality of life based on cancer stage Show forest plot | 6 | 695 | Std. Mean Difference (IV, Random, 95% CI) | 0.04 [‐0.11, 0.18] |
| 2.3.1 Early stage studies | 3 | 490 | Std. Mean Difference (IV, Random, 95% CI) | ‐0.02 [‐0.20, 0.17] |
| 2.3.2 Mixed and unknown studies | 3 | 205 | Std. Mean Difference (IV, Random, 95% CI) | 0.15 [‐0.13, 0.42] |
| 2.4 Loss of body weight based on cancer stage Show forest plot | 4 | 541 | Mean Difference (IV, Random, 95% CI) | 0.41 [‐0.77, 1.59] |
| 2.4.1 Early stage studies | 3 | 491 | Mean Difference (IV, Random, 95% CI) | 0.37 [‐0.86, 1.59] |
| 2.4.2 Mixed and unknown studies | 1 | 50 | Mean Difference (IV, Random, 95% CI) | 0.90 [‐3.43, 5.23] |
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 3.1 Length of hospital stay in studies without skewed data Show forest plot | 5 | 722 | Mean Difference (IV, Random, 95% CI) | 0.62 [0.16, 1.09] |
| 3.2 Postoperative morbidity in studies in which use of Clavien‐Dindo classification was not unclear Show forest plot | 5 | 463 | Risk Ratio (M‐H, Random, 95% CI) | 1.39 [0.87, 2.24] |
| 3.3 Incidence of anastomotic leakage with a fixed‐effect model Show forest plot | 5 | 711 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.61 [0.19, 1.93] |
| 3.4 Health‐related quality of life in studies without benign disease patients Show forest plot | 5 | 665 | Std. Mean Difference (IV, Random, 95% CI) | 0.04 [‐0.12, 0.19] |
| 3.5 Loss of body weight in studies not limited to diabetic patients Show forest plot | 3 | 501 | Mean Difference (IV, Random, 95% CI) | 0.53 [‐0.72, 1.77] |
| 3.6 Health‐related quality of life in studies without co‐intervention bias Show forest plot | 5 | 559 | Std. Mean Difference (IV, Random, 95% CI) | ‐0.01 [‐0.18, 0.15] |
