Koc 2005.
Methods | Randomised clinical trial. | |
Participants | Country: Turkey.
Number randomly assigned: 53.
Postrandomisation dropouts: three (5.7%).
Revised sample size: 50. Mean age: 47 years. Females: 41 (82%). Inclusion criteria: 1. Elective laparoscopic cholecystectomy for symptomatic gall stones. 2. ASA I to III. Exclusion criteria: 1. Acute cholecystitis or acute pancreatitis. 2. Common bile duct exploration or another surgical procedure. 3. Treatment with drugs that influence neurohormonal parameters. |
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Interventions | Participants were randomly assigned to different pressures of pneumoperitoneum. Group 1: low pressure 10 mm Hg (n = 25). Group 2: standard pressure 15 mm Hg (n = 25). | |
Outcomes | The outcome reported was operating time. | |
Notes | Reason for postrandomisation dropout: conversion to open cholecystectomy
(group not stated). Attempts to contact the trial authors in February 2008 were unsuccessful. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Comment: This information was not available. |
Allocation concealment (selection bias) | Low risk | Quote: "...patients were randomized to low‐ or high‐pressure pneumoperitoneum groups by closed envelope method in the operating room prior to surgery." |
Blinding (performance bias and detection bias) All outcomes | High risk | Quote: "...a short‐form MGQ (SF‐MGQ) was obtained from all patients by a research assistant who was blind to the group allocation of the patients." Comment: Assessor blinding of primary outcomes was not performed, and so the blinding is inadequate in this trial. |
Incomplete outcome data (attrition bias) All outcomes | High risk | Comment: Three postrandomisation dropouts were due to conversion to open cholecystectomy. |
Selective reporting (reporting bias) | High risk | Comment: Important outcomes such as mortality and morbidity were not reported. |
For‐profit bias? | Unclear risk | Comment: This information was not available. |