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/m 2 , 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.
Vaginoplasty surgery is performed in transgender women who opt to surgically transition and undergo genital affirmation. The most commonly performed procedure is a modification of the penile inversion technique.
Why was this study conducted?
There is currently a paucity of evidence-based data and few reports on outcomes related to all of the varying techniques for vaginoplasty, and case thresholds for favorable outcomes have also never been described.
Key findings
In this study, the incidence of serious adverse events was low, whereas minor events were common, most of which were delayed. After a threshold of 50 vaginoplasty cases, these delayed events were reduced, including the need for revision surgery.
What does this add to what is known?
These data can help guide us as we continue to develop training programs for this type of surgery and can also help us with our patient counseling at the time of the informed consent process.
A MEDLINE review (2000–2019) reveals an abundance of reports on the surgical techniques for vaginoplasty surgery. However, careful review reveals a paucity of evidence-based data and few reports on outcomes related to all of the varying techniques. A recently published systematic review of 46 papers by Manrique et al indicated that the most commonly reported complications associated with vaginoplasty included vaginal stenosis and strictures, neovaginal prolapse, tissue necrosis, and neovaginal fistula. In the review, the authors also reported high rates of patient overall satisfaction with surgery and favorable functional and cosmetic outcomes.
Other reviews and observational studies have reported similar findings , and the take-home message is that this surgery is safe in the right hands and it is effective in improving quality of life parameters for transitioning patients. However, it is apparent that there is a lack of standardization in how data are collected in these patients, and hence, efforts must be put forth in the research community to better study this surgery.
Currently, there is an interest in learning how to perform vaginoplasty surgery because many medical centers have been incorporating transgender-specific care into their service lines. Historically, training for this type of surgery has been difficult to obtain for the following reasons: it is not specific to 1 subspecialty, there is no credentialing board for the surgery, and formal postgraduate surgical programs have only started to develop at a few centers. As surgical programs continue to evolve, the important question becomes, at what case threshold are cases performed safely, efficiently, and with favorable outcomes? This type of data can help guide us in how we train future surgeons and also provide us with information about the necessary “in practice” learning curve. This study aimed to review the experiences at our center and to describe perioperative adverse events related to vaginoplasty surgery performed for gender affirmation and to determine a threshold case number needed to reduce these events.
Materials and Methods
This was a retrospective study of all women who underwent vaginoplasty surgery for gender affirmation at a single tertiary care center between December 2015 and March 2019. Institutional Review Board approval was obtained for this study. Patients were identified by the Current Procedural Terminology codes used to bill for vaginoplasty surgery. All cases were performed by a single board-certified female pelvic medicine and reconstructive surgery (FPMRS) specialist. Women were included in the study if 6-month postoperative outcomes were available, which included an in-office visit and physical examination. Patients were also included if they underwent a full-depth vaginoplasty procedure (vulvoplasty with vaginal canal creation and grafting) or no-depth vaginoplasty surgery (vulvoplasty only). Decision to pursue 1 procedure over the other was made preoperatively and was a joint decision between the patient and surgeon based on the patient’s desire for vaginal penetrative intercourse, comorbid conditions, and acceptance of the risk associated with the vaginal canal portion of the surgery.
Once patients were identified, perioperative data, including preoperative patient characteristics, were collected from the system-wide electronic medical record. The 6-month office visit was standardized, and all patients underwent vulvovaginal examinations such as measurement of neovaginal length and an assessment of postoperative symptoms. All postoperative visits were performed by 1 of 2 providers.
Adverse events were defined as intraoperative, immediate (within 30 days of surgery) or delayed (after 30 days and within 6 months of surgery). Intraoperative adverse events included estimated blood loss ≥500 mL and/or need for transfusion, genitourinary injury, and rectal injury. Immediate adverse events included reoperation, readmission, urinary retention, genitourinary fistula, rectovaginal fistula, flap necrosis, incision dehiscence, and wound infection. Delayed adverse events included abnormal urinary stream, neovaginal stenosis, pelvic pain, and introital stenosis. The incidence of need for revision surgery (defined as elective, cosmetic, or functional revision) was also recorded.
At the time of study design, a cursory review of the electronic medical records revealed that all delayed adverse events occurred within 6 months of the index surgery; hence this follow-up period was chosen as the inclusion criteria for the study, with the additional advantage that all patients are seen for a 6-month postoperative visit and examination as part of our routine practice. Although not all revision surgeries were performed within the 6-month follow-up period, all of them were identified as needed and planned during that time.
An a priori review of the literature , was performed 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. The following incidence rates were used: fistula (rectovaginal, genitourinary), 1% to 2%; vaginal and introital stenosis and strictures, 10% to 20%; tissue necrosis, 1% to 5%; cosmetic revision, 10% to 20%; and urinary stream abnormalities, 5% to 10%. In addition, an informal query of surgeons who perform these surgeries regularly was done to determine a case time threshold that could be considered an “efficient” time to perform these surgeries. This median (range) case time was determined to be 180 (120–240) minutes. For the purposes of this study, case time was defined as time of incision to time of incision closed and dressing applied.
Comparisons of adverse events and perioperative outcomes were made between varying threshold case numbers using increments of 10 (eg, >20, >30, >40, >50) to determine the case number needed to reduce adverse events in a clinically significant way, to reach previously published incidence rates, and to reduce median (range) case time to 180 (120–240) minutes. Once this threshold was determined, outcomes were compared between cases performed before and after this threshold. This study was mostly descriptive. Continuous data were presented as mean (±standard deviation) and median (range). Categorical data were presented as % (n) or n (%). Comparisons of outcomes were done using the Mann–Whitney U test for continuous variables and the chi-square test for categorical variables. Logistic regression was used to control for any variables found to be significant on univariate analysis or clinically significant during analysis planning. P ≤.05 was considered statistically significant. JMP software version 14.0 was used for all statistical analyses.
Results
Between December 2015 and March 2019, vaginoplasty was performed in 76 (n) cases. Outcomes data for 6 months were available for all patients. Patient characteristics are presented in Table 1 . Mean age and body mass index of all patients were 41 (±17) years and 27.3 (±5.1) kg/m 2 , respectively. Median 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 (5) underwent a zero-depth procedure (no neovagina, vulva only). Median surgical time for the entire cohort was 210 (138–362) minutes. Median follow-up for all patients was 12.5 (6–50) months.
| All patients n=76 | Cases 1–50 n=50 | Cases 51–76 n=26 | P value | |
|---|---|---|---|---|
| Age, y | 41 (17) | 44 (16) | 35 (16) | .02 a |
| BMI, kg/m 2 | 27.3 (5.1) | 27.8 (5.4) | 26.3 (4.4) | .22 |
| Tobacco use | 10.5 (8) | 8.2 (4) | 14.8 (4) | .37 |
| HIV | 2.6 (2) | 2.0 (1) | 3.7 (1) | .66 |
| Diabetes | 6.6 (5) | 8.2 (4) | 3.7 (1) | .45 |
| Cardiac disease | 14.5 (11) | 18.4 (9) | 7.4 (2) | .19 |
| COPD, asthma | 3.9 (3) | 6.1 (3) | 0 (0) | .19 |
| Previous prostate surgery | 5.3 (4) | 8.1 (4) | 0 (0) | .13 |
| Previous orchiectomy | 7.9 (6) | 10.2 (5) | 3.7 (1) | .31 |
| Hormone therapy, mo | 36 (12–360) | 36 (12–360) | 42 (12–108) | .47 |
| Type of vaginoplasty | .45 | |||
| Full depth | 83.4 (71) | 92.0 (46) | 96.2 (25) | |
| No depth | 6.6 (5) | 8.0 (4) | 3.8 (1) | |
| Follow-up, mo | 12.5 (6–50) | 14 (6–50) | 6 (6–13) | .001 a |
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