Same-day discharge after laparoscopic hysterectomy for benign/premalignant disease: A multicentre randomised controlled trial

Abstract

Objective: To evaluate whether physical function and quality of life was influenced by discharge on the same-day after a total laparoscopic hysterectomy. Design: Multicentre non-inferiority randomised controlled trial. Setting: Five teaching hospitals and two university hospitals in the Netherlands. Population: Patients undergoing laparoscopic hysterectomy for benign or premalignant disease. Methods: Following informed consent, participants were allocated 1:1 either to same-day discharge (SDD) or next-day discharge (NDD). Main Outcome Measures: The primary outcome was physical function at 7 days after surgery measured by the Patient Reported Outcomes Measurement Information System (PROMIS) Physical Function short Form 10A. Secondary outcomes were physical function and quality of life at 1 and 3 days and 6 weeks after surgery measured with PROMIS short Form 10A and the EuroQol questionnaire (EQ-5D-5L). Results: Two hundred and five patients were included of whom 105 were allocated to SDD and 100 to NDD. Physical function 7 days after surgery was 35.95 in the SDD group and 35.63 in the control group (mean difference 0.32; 95% CI [0.07–0.57]). As the upper limit of the 95% CI does not exceed the non-inferiority margin of 4 points, non-inferiority of SDD could be demonstrated. No difference in physical function nor quality of life on Days 1 and 3 and 6 weeks could be found. Conclusion: This research demonstrates same-day discharge after laparoscopic hysterectomy is non-inferior to next day discharge in physical function 7 days after surgery.