| Methods |
Randomised clinical trial. |
| Participants |
Country: Thailand.
Number randomly assigned: 140.
Postrandomisation dropouts: zero (0%).
Revised sample size: 140.
Average age: 55 years.
Females: 111 (79.3%).
Successful completion of low pressure laparoscopic cholecystectomy: 68/70 (97.1%).
Intraoperative cholangiogram: not stated.
Inclusion criteria:
1. Adults with American Society of Anesthesiologists (ASA) physical status grade I or II.
2. Undergoing elective laparoscopic cholecystectomy for benign gall bladder.
Exclusion criteria:
1. Patients younger than 18 years.
2. Those who refused to give consent.
3. Inability to understand the research questionnaire.
4. Pregnancy.
5. Patients who were found to require additional procedures at surgery. |
| Interventions |
Participants were randomly assigned to different pressures of pneumoperitoneum.
Group 1: low pressure 7 mm Hg (n = 70).
Group 2: standard pressure 14 mm Hg (n = 70). |
| Outcomes |
Outcomes reported were mortality, morbidity, conversion to open cholecystectomy, operating time, and hospital stay. |
| Notes |
Study authors provided additional information in March 2013.
Reasons for postrandomisation dropouts: not stated. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Quote: "After induction of anesthesia, patients were randomized prospectively by computer generation." |
| Allocation concealment (selection bias) |
Low risk |
Quote: "Put a coded card (label pressure 7 mmHg or 14 mmHg as prospectively randomized by computer generation) in an opaque, sealed, and sequentially numbered envelope. Then open the envelope before surgery by surgeon (author replies)." |
| Blinding (performance bias and detection bias)
All outcomes |
Low risk |
Quote: "both the patients and healthcare providers were blinded. The outcome assessors were blinded as well (author replies)." |
| 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 not supported by any funding sources. We used our own budget (author replies)." |
