| Methods |
Randomised clinical trial. |
| Participants |
Country: Netherlands.
Number randomised: 80.
Post‐randomisation drop‐outs: 6 (7.5%).
Revised sample size: 74.
Average age: 44 years.
Women: 62 (83.8%).
Inclusion criteria
1. ASA status I ‐ II.
2. Age < 70 years.
3. Participants undergoing laparoscopic cholecystectomy for symptomatic gallstones.
4. Living within 50 km from the hospital.
5. Participants who had an adult willing to accompany them home and to stay with them for at least 24 hours.
Exclusion criteria
1. Obesity.
2. Extensive previous abdominal surgery.
3. Common bile duct stones.
4. Acute cholecystitis.
5. Pancreatitis. |
| Interventions |
Participants were randomly assigned to two groups.
Group 1: day‐case laparoscopic cholecystectomy (n = 37).
Group 2: overnight stay laparoscopic cholecystectomy (n = 37).
The LC procedures were performed during the morning. Discharge was allowed if participants required oral pain medication only, tolerated oral fluids, could walk to the lavatory, had passed urine spontaneously, and felt confident that they could manage at home. The decision about discharge was made by both the surgeon and the anaesthesiologist before 7 pm. |
| Outcomes |
The outcomes reported were morbidity, failed discharge (clearly reported for day‐surgery group but not for overnight stay group), hospital readmissions, quality of life (EuroQoL at 1 week), and return to work. |
| 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) |
Low risk |
Quote: "Patients were then randomly allocated, by opening a sealed envelope, to either the day‐care group or the clinical observation group."
Comment: Allocation concealment was probably performed adequately. |
| 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 |
Low risk |
Comment: Participants with acute cholecystitis, acute cholangitis or who postponed surgery because of lack of symptoms were excluded from both groups. This reflects the real‐life situation. These post‐randomisation drop‐outs will not cause bias due to missing outcome data. |
| Selective reporting (reporting bias) |
High risk |
Comment: Mortality was not reported explicitly. |
| Vested interest bias |
Low risk |
Quote: "Supported by a grant from the Richtlijnen Commissie AMC (Committee for Development of Clinical Guidelines)." |
