Roux‐en‐Y versus Billroth‐I reconstruction after distal gastrectomy for gastric cancer

Daisuke Nishizaki; Riki Ganeko; Nobuaki Hoshino; Koya Hida; Kazutaka Obama; Toshi A Furukawa; Yoshiharu Sakai; Norio Watanabe

doi:10.1002/14651858.CD012998.pub2

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Figure 1

Study flow diagram.

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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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Figure 4

Forest plot of comparison: 1 Roux‐en‐Y versus Billroth‐I reconstruction, outcome: 1.1 Health‐related quality of life.

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Figure 5

Forest plot of comparison: 1 Roux‐en‐Y versus Billroth‐I reconstruction, outcome: 1.2 Incidence of anastomotic leakage.

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Figure 6

Forest plot of comparison: 1 Roux‐en‐Y versus Billroth‐I reconstruction, outcome: 1.3 Loss of body weight.

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Analysis 1.1

Comparison 1: Roux‐en‐Y versus Billroth‐I reconstruction, Outcome 1: Health‐related quality of life

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Analysis 1.2

Comparison 1: Roux‐en‐Y versus Billroth‐I reconstruction, Outcome 2: Incidence of anastomotic leakage

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Analysis 1.3

Comparison 1: Roux‐en‐Y versus Billroth‐I reconstruction, Outcome 3: Loss of body weight

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Analysis 1.4

Comparison 1: Roux‐en‐Y versus Billroth‐I reconstruction, Outcome 4: Incidence of bile reflux

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Analysis 1.5

Comparison 1: Roux‐en‐Y versus Billroth‐I reconstruction, Outcome 5: Length of hospital stay

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Analysis 1.6

Comparison 1: Roux‐en‐Y versus Billroth‐I reconstruction, Outcome 6: Postoperative morbidity

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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Summary of findings 1. Roux‐en‐Y compared to Billroth‐I after distal gastrectomy for gastric cancer

Outcomes	*Anticipated absolute effects^ (95% CI)**		Relative effect (95% CI)	№ of participants (studies)	Certainty of the evidence (GRADE)	Comments
Roux‐en‐Y compared to Billroth‐I after distal gastrectomy for gastric cancer
Patient or population: people undergoing distal gastrectomy for gastric cancer Setting: operating room in a hospital Intervention: Roux‐en‐Y Comparison: Billroth‐I
Outcomes	Risk with Billroth‐I	Risk with Roux‐en‐Y	Relative effect (95% CI)	№ of participants (studies)	Certainty of the evidence (GRADE)	Comments
Health‐related quality of life	‐	SMD 0.04 higher (0.11 lower to 0.18 higher)	‐	695 (6 RCTs)	⊕⊕⊝⊝ LOW^1,2	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 (2 to 36)	RR 0.63 (0.16 to 2.53)	711 (5 RCTs)	⊕⊝⊝⊝ VERY LOW^3,4
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 (0.77 smaller to 1.59 greater).	‐	541 (4 RCTs)	⊕⊕⊝⊝ LOW^3,5	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 (99 to 250)	RR 0.40 (0.25 to 0.63)	399 (4 RCTs)	⊕⊕⊕⊝ MODERATE⁶
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 (0.16 to 1.76 days longer).	‐	894 (7 RCTs)	⊕⊝⊝⊝ VERY LOW^3,7,8	Length of hospital stay is expressed in days, and ranges from 1 to infinite.
Postoperative morbidity	99 per 1000	146 per 1000 (101 to 209)	RR 1.47 (1.02 to 2.11)	891 (7 RCTs)	⊕⊕⊝⊝ LOW ^3,9
*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 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.
¹Downgraded one level due to imprecision; 95% CIs are compatible with both benefit and harm. ²Downgraded one level due to risk of bias; participants were not blinded despite this being a patient‐reported outcome. ³Downgraded one level due to risk of bias; surgeons were not blinded ⁴Downgraded by two levels due to imprecision; 95% CIs are wide due to rare events, with possibility of substantial harm and substantial benefit, suggesting very serious imprecision. ⁵Downgraded one level due to imprecision; small sample size — outcome included only four studies. ⁶Downgraded one level due to risk of bias; outcome assessors may not have been blinded. ⁷Downgraded one level due to risk of bias; incomplete reporting on the results indicating data are skewed. ⁸Downgraded one level due to inconsistency; substantial heterogeneity was observed. ⁹Downgraded one level due to inconsistency; possible inconsistencies in trial results due to different diagnostic criteria used to report complications.

Summary of findings 1. Roux‐en‐Y compared to Billroth‐I after distal gastrectomy for gastric cancer

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Table 1. Details of complications reported in included studies

Study	Roux‐en‐Y	Affected participants in Roux‐en‐Y	Billroth‐I	Affected participants in Billroth‐I
Choi 2017	1 Atelectasis 1 Bleeding	2/20	1 Atelectasis 1 Complicated fluid	2/20
Hur 2017	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
Yang 2017	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
Nakamura 2016	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
Lee 2012	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
Takiguchi 2012	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
Ishikawa 2005	3 Gastric stasis 1 Intestinal obstruction 1 Pneumonia 2 Anastomotic stricture	6/24	1 Leakage 1 Intestinal obstruction	2/26

Table 1. Details of complications reported in included studies

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Comparison 1. Roux‐en‐Y versus Billroth‐I reconstruction

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]

Comparison 1. Roux‐en‐Y versus Billroth‐I reconstruction

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Comparison 2. Subgroup analysis in Roux‐en‐Y versus Billroth‐I reconstruction

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]

Comparison 2. Subgroup analysis in Roux‐en‐Y versus Billroth‐I reconstruction

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Comparison 3. Sensitivity analysis in Roux‐en‐Y versus Billroth‐I reconstruction

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]

Comparison 3. Sensitivity analysis in Roux‐en‐Y versus Billroth‐I reconstruction

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