Gender-Affirming Vaginoplasty: Reducing Complications

Surgeon experience is key to reducing adverse events

Numerous reports exist in the literature about techniques for vaginoplasty but data are lacking on outcomes of the procedures. A new analysis of cases performed at Cleveland Clinic helps fill that evidence gap and points to surgeon experience as the key factor in reducing adverse events.

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Maintaining transparency and improving outcomes

Published in The American Journal of Obstetrics and Gynecology, the retrospective study looked at outcomes of 76 vaginoplasty cases at the institution from December 2015 to March 2019. All the surgeries were performed by a single board-certified female pelvic medicine and reconstructive surgery specialist, Cecile A. Ferrando, MD, MPH, who also authored the article.

In Dr. Ferrando’s hands, 50 cases were the threshold after which adverse events were reduced in both clinically and statistically significant ways. Surgical times were lower (187 minutes [range 138-224] versus 240 minutes [range 162-362]; P < .0001), as was incidence of delayed postoperative adverse events (15.4% versus 36%, P = .001). That included fewer urinary stream abnormalities (7.7% versus 16.3%), less introital stenosis (3.9% versus 12%, P = .04), and less need for revision surgery (19.2% versus 44%, P=.004).

Controlling for patient age, history of smoking and diabetes did not change the outcomes. The patients in the study had a mean age and body mass index of 41 years and 27.3 kg/m2, respectively. Median time on hormone therapy before surgery was 36 months and 7.9% of patients had undergone previous orchiectomy.

The threshold of surgical cases after which adverse events decline

Interestingly, the only type of adverse event that was affected by case number and experience was the delayed adverse event, which is considered minor compared to intraoperative or immediate postoperative complications. The incidence of intraoperative complications was low in all cases, regardless of case number, and there was no difference in immediate adverse events comparing cases 51–76 with cases 1–50. This shows that in the right hands, this surgery is safe, and only minor adverse events improve with time and increased case number.

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“Once you get to a certain case number, both cosmetic and functional outcomes are improved,” says Dr. Ferrando, who is Program Director of the Female Pelvic Medicine and Reconstructive Surgery Fellowship and Director of Cleveland Clinic’s Center for Lesbian, Gay, Bisexual and Transgender (LGBTQ+) Care. “The decline in delayed postoperative events over time was expected, but it was drastic after the 50-case threshold — from 1 in 2 patients to 1 in 5 needing cosmetic revisions.”

The frame of reference for the threshold was a review of the literature to determine the incidence rates for adverse events commonly reported with vaginoplasty. The goal was to determine a threshold case number needed to replicate those rates and compare outcomes for Cleveland Clinic procedures performed before and after a surgeon achieved that number.

In 83.4% of the cases, a full-depth vaginoplasty was performed, and in 16.6% of cases, a zero-depth procedure was performed. Median follow-up was 12.5 months. Incidences of intraoperative, immediate (< 30 days) and delayed (> 30 days to < 6 months) adverse events were 2.6%, 19% and 25%, respectively. Most of the immediate adverse events were associated with postoperative wound issues, either incisional dehiscence or flap necrosis.

“The most common complications were delayed, including abnormal urinary stream and cosmetic complications,” says Dr. Ferrando. “They were managed with revision surgery 3–6 months after the original surgery.”

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The revision surgeries were done on an outpatient basis and included any combination of labiaplasty and/or clitoroplasty for cosmesis, introitoplasty surgery for vaginal introital narrowing, and urethroplasty for abnormal urinary stream resulting from urethral meatal scarring.

Subspecialty education for surgeons

In addition to the clinical ramifications of the 50-case threshold, it also should be considered in the context of surgeon education, says Dr. Ferrando. “This is a specialized procedure and 50 cases may be an appropriate threshold for postgraduate programs to require for trainees in order to support successful outcomes.” Starting this academic year, Cleveland Clinic is offering the first formal training program in transgender surgery for Ob/Gyn subspecialty graduates.

Regarding additional research on gender-affirming vaginoplasty in the near future, a study is being planned on outcomes of revision surgery, for which patients are often referred to Cleveland Clinic. In 5–10 years, Dr. Ferrando may attempt to replicate the present study, perhaps in patients who have undergone puberty suppression in childhood.

“Puberty suppression became popular in the mid-2000s so we’re only now starting to see adults seeking surgery who were exposed to it as teens. Their anatomy is very different,” she says. “We would also like to look at other subgroups, but we need a bigger cohort to do that. Above all, we want to continue to innovate this surgery and be transparent about our outcomes.”