Chok 2006.
Methods | Randomised clinical trial. | |
Participants | Country: China.
Number randomly assigned: 40.
Postrandomisation dropouts: zero.
Revised sample size: 40. Mean age: 47 years. Females: 24 (60%). Inclusion criteria: 1. Symptomatic cholelithiasis with or without complications. 2. Elective outpatient cholecystectomy. 3. ASA I or II. 4. Age < 70 years. |
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Interventions | Participants were randomly assigned to different pressures of pneumoperitoneum. Group 1: low pressure 7 mm Hg (n = 20). Group 2: standard pressure 12 mm Hg (n = 20). | |
Outcomes | Outcomes reported were mortality, morbidity, conversion to open cholecystectomy, and operating time. | |
Notes | Trial authors provided additional information in February 2008 and March 2013. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "The random sequence is from random number table (author replies)." |
Allocation concealment (selection bias) | Low risk | Quote: "Randomization was performed preoperatively at the pre‐anesthetic clinic by drawing consecutive sealed and numbered envelopes by an independent third party (author replies)." |
Blinding (performance bias and detection bias) All outcomes | High risk | Quote: "A preset questionnaire was completed on postoperative days 1 and 3 through telephone by the nursing staff, who were blinded to the randomization results (author replies)." 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 | Low risk | Comment: No postrandomisation dropouts were reported. |
Selective reporting (reporting bias) | Low risk | Comment: Important outcomes such as mortality and morbidity were reported. |
For‐profit bias? | Low risk | Quote: "This study was funded by the Tung Wah Group of Hospitals (TWGHs) Research Fund‐Research Project." |