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.