Adverse events associated with gender affirming vaginoplasty surgery

Abstract

Background: There is an abundance of reports on the surgical techniques for vaginoplasty surgery. However, careful review reveals a paucity of evidence-based data in addition to few reports on outcomes related to all of the varying techniques.

Objective: This study aimed to describe the perioperative adverse events related to vaginoplasty surgery for transgender women and to determine a threshold case number needed to reduce adverse events.

Study design: This was a retrospective study of all women who underwent vaginoplasty surgery for gender affirmation at a tertiary care center. All cases were performed by a single board-certified female pelvic medicine and reconstructive surgery specialist. Women were included if 6-month outcomes were available. Once patients were identified, perioperative data were collected. Comparisons of adverse events and perioperative outcomes were made between varying threshold case numbers to determine the case number needed to significantly reduce adverse events. An a priori review of the literature was done to determine the incidence of commonly reported adverse events, and these incidences were used as a frame of reference to determine a threshold case number needed to replicate these reported incidence rates. Once this threshold was determined, outcomes were compared between cases performed before and after this threshold.

Results: Between December 2015 and March 2019, 76 vaginoplasty surgeries were performed. Six-month outcomes data were available for all patients. Mean age and body mass index of all patients were 41 (±17) years and 27.3 (±5.1) kg/m², respectively. Median (range) time on hormone therapy preceding surgery was 36 (12-360) months, and 7.9% (6) of patients had undergone previous orchiectomy. Of the patients, 83.4% (71) underwent full-depth vaginoplasty, whereas the remaining patients underwent a zero-depth procedure. Median (range) surgical time was 210 (138-362) minutes. Median (range) follow-up for all patients was 12.5 (6-50) months. The incidence of any intraoperative adverse event was 2.6% (95% confidence interval, 1.8-4.1) for all patients, whereas the incidence of any immediate (<30 days) and delayed (>30 days and <6 months) postoperative event was 19% (95% confidence interval, 16.4-22.2) and 25% (95% confidence interval, 22.4-28.4), respectively. Performance of 50 cases was identified to be a threshold that reduced adverse events in both clinically and statistically significant ways. Cases performed after the first 50 cases had lower surgical times (187 (138-224) vs 240 (162-362) minutes, P<.0001), a lower incidence of delayed postoperative adverse events (15.4% vs 36%, P=.007), including a lower incidence of urinary stream abnormalities, introital stenosis, and the need for revision surgery. The incidence of intraoperative and immediate adverse events was not different between the groups.

Conclusion: The incidence of serious adverse events related to vaginoplasty surgery is low, whereas minor events are common. After a threshold of 50 vaginoplasty surgeries, these events were reduced, including the need for revision surgery.

Keywords: gender affirmation surgery; gender confirmation surgery; perioperative adverse events; sex reassignment surgery; transgender; vaginoplasty.