Summary of findings for the main comparison. Summary of findings in the analysed outcomes.
| Laparoscopic‐endoscopic rendezvous versus preoperative endoscopic sphincterotomy in people undergoing laparoscopic cholecystectomy for stones in the gallbladder and common bile duct | ||||||
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Population: patients with stones in the gallbladder and common bile duct undergoing laparoscopic cholecystectomy
Settings: inpatients
Intervention: laparoscopic‐endoscopic rendezvous (LERV) Control: preoperative endoscopic sphincterotomy | ||||||
| Outcomes | Anticipated absolute effects* (95% CI) | Relative effect (95% CI) | № of participants (studies) | Quality of the evidence (GRADE) | Comments | |
| Risk with preoperative endoscopic sphincterotomy | Risk with laparoscopic‐endoscopic rendezvous | |||||
| Overall mortality (30‐day postoperative; procedure‐ and non‐procedure related) |
Study population | 516 (5 RCTs) | ⊕⊕⊝⊝ LOW 1,2 | Only 1 death in 1 trial reported, in the LERV group | ||
| 0 per 1000 | 0 per 1000 (0 to 0) | |||||
| Overall morbidity (30‐day postoperative; procedure‐ and non‐procedure related) |
Study population | RR 0.59 (0.29 to 1.20) | 433 (4 RCTs) | ⊕⊕⊝⊝ LOW 1,3 | No trials defined overall morbidity in the methods section. | |
| 142 per 1000 | 84 per 1000 (41 to 169) | |||||
| Moderate | ||||||
| 128 per 1000 | 75 per 1000 (37 to 152) | |||||
| Failure of primary clearance | Study population | RR 0.55 (0.22 to 1.38) | 516 (5 RCTs) | ⊕⊝⊝⊝ VERY LOW 1,3,4 | ||
| 131 per 1000 | 72 per 1000 (29 to 181) | |||||
| Moderate | ||||||
| 102 per 1000 | 56 per 1000 (22 to 141) | |||||
| Clinical postoperative pancreatitis | Study population | RR 0.31 (0.09 to 1.14) | 516 (5 RCTs) | ⊕⊕⊝⊝ LOW 1,3 | ||
| 73 per 1000 | 23 per 1000 (7 to 84) | |||||
| Moderate | ||||||
| 100 per 1000 | 31 per 1000 (9 to 114) | |||||
| Operative time | The mean operative time in the control groups was 88.6 minutes | The mean operative time in the LEVR groups was 34.07 minutes higher (11.41 to 56.74 higher) | MD: 34.07 (11.41 to 56.74) | 313 (3 RCTs) | ⊕⊝⊝⊝ VERY LOW 1,3,5 | TSA: 23.07 (15.32 to ‐30.81) |
| Length of hospital stay | The mean length of hospital stay in the control groups was 7.5 days | The mean length of hospital stay in the LEVR groups was 3.01 days shorter (3.51 to 2.5 days shorter) | MD: ‐3.01 (‐3.51 to ‐2.50) | 515 (5 RCTs) | ⊕⊕⊝⊝ LOW 1,3 | TSA: ‐2.87 (3.66 to ‐2.07) |
| *The risk in the intervention (LEVR) group (and its 95% CI) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: Confidence interval; RR: Risk ratio; OR: Odds ratio; RCT: randomised clinical trial; TSA: Trial Sequential Analysis | ||||||
| GRADE Working Group grades of evidence High quality: We are very confident that the true effect lies close to that of the estimate of the effect Moderate quality: 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 quality: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect Very low quality: 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 due to risk of bias: high risk of performance and detection bias in all the trials, unclear risk of selection bias in two trials, unclear risk of selective reporting in three trials and high risk in one trial, unclear risk of for‐profit bias in four trials 2Downgraded one level due to imprecision: very low event rate 3Downgraded one level due to imprecision: few trials with few participants 4Downgraded one level due to inconsistency: high heterogeneity among trials ( I² = 58%) 5Downgraded one level due to inconsistency: very high heterogeneity among trials ( I² = 93%)