Dirksen 2001.
| Methods | Randomised clinical trial. | |
| Participants | Country: Netherlands. Number randomised: 94. Post‐randomisation drop‐outs: 8 (8.5%). Revised sample size: 86. Average age: 47 years. Women: 68 (79.1%). Inclusion criteria 1. Participants aged between 18 and 80 years having symptomatic gallstones. Exclusion criteria 1. Complicated gallstones. 2. Participants with an American Society of Anesthesiology [ASA] classification of III or IV. 3. Other interventions during operation. 4.No support at home until 24 hours after the operation. 5. Trip time between house and hospital longer than 30 minutes. 6. No good control of the Dutch language. 3. Participants with extensive previous abdominal surgery. 4. Clinical suspicion of common bile duct stones. 5. Acute cholecystitis. 6. Calcified gallbladder. | |
| Interventions | Participants were randomly assigned to two groups. Group 1: day‐case laparoscopic cholecystectomy (n = 42). Group 2: overnight stay laparoscopic cholecystectomy (n = 44). The discharge criteria were no or manageable nausea and/or vomitus, good pain control, spontaneous micturition and absence of a complication. | |
| Outcomes | The outcomes reported were short‐term mortality, morbidity, failed discharge, hospital readmissions, and quality of life (EUROQoL at 1 week). | |
| Notes | We attempted to contact the authors in February 2007 and September 2012. | |
| 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) | Unclear risk | Quote: "After informed license, patients were randomised to day‐surgery or clinical observation by the secretary with help of closed envelopes." Comment: Further details were not available. |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Comment: It is not possible to blind the participants for this comparison. |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Comment: This information was not available. |
| Incomplete outcome data (attrition bias) All outcomes | High risk | Comment: There were post‐randomisation drop‐outs which might have altered the effect estimates. |
| Selective reporting (reporting bias) | Low risk | Comment: All important outcomes (short‐term mortality and serious adverse events) were reported. |
| Vested interest bias | Unclear risk | Comment: This information was not available. |