Ambulatory Versus Inpatient Total Laparoscopic Hysterectomy in Trans Men: A Randomised Controlled Non-Inferiority Trial.

Abstract

This study investigates whether total laparoscopic hysterectomy in trans men can be safely performed as an ambulatory procedure without negatively impacting patient satisfaction with length of stay compared to inpatient surgery. Single-centre non-inferiority randomised controlled trial. Ghent University Hospital, Belgium. Trans men scheduled for total laparoscopic hysterectomy. Participants were randomly allocated to ambulatory surgery (intervention) or overnight stay (comparator). The main outcome was satisfaction with the length of hospital stay, measured on Day 7 postoperatively. Secondary outcomes were pain scores, analgesics use, quality of recovery, hospital anxiety and depression, complications, and readmission. One hundred trans men gave informed consent. Ninety-four underwent surgery (50 allocated inpatient and 44 ambulatory). The non-inferiority margin for the primary outcome was -20 on a 100-point VAS. Total laparoscopic hysterectomy as an ambulatory procedure was non-inferior to the inpatient setting regarding satisfaction with length of hospital stay after 1 week (mean difference 1.45; 95% CI: -6.71 to 9.61). There were lower pain scores in the ambulatory group, along with significantly more use of moderate analgesics on Days 1, 2, and 3 (resp. risk difference 0.35 (95% CI: 0.17-0.53), 0.32 (95% CI: 0.10-0.54), 0.31 (95% CI: 0.10-0.52)). The quality of recovery and hospital anxiety and depression scores were comparable between both groups. The readmission and postoperative complication rates were higher in the inpatient group. This study shows non-inferiority for patient satisfaction with length of hospital stay after hysterectomy in the ambulatory versus inpatient setting in a transgender population. ClinicalTrials.gov: NCT05393583.