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Functional, aesthetic, and sensory postoperative complications of female genital gender affirmation surgery: A prospective study

Open AccessPublished:August 21, 2022DOI:https://doi.org/10.1016/j.bjps.2022.08.032

      Summary

      Background

      Female genital gender affirmation surgeries have increased in recent years. Prospective studies with homogeneous standardized techniques and outcomes assessment are scarce in the current literature.
      This study aims to: 1) report the functional, aesthetic, and sensory postoperative complications (POCs) of primary genital gender confirmation surgeries performed on transgender women and 2) compare functional and aesthetic POCs amongst three vaginoplasty techniques: inverted penile skin, penoscrotal skin graft, and pedicled intestinal flap vaginoplasty.

      Methods

      All (n = 84) consecutive transfemale individuals who underwent primary genital gender confirmation surgery from January 2015 to December 2016 at IMCLINIC were prospectively followed. Functional, aesthetic, and sensory POCs were registered according to the Clavien-Dindo POC classification.

      Results

      Functional POC rates after vaginoplasty at our centre were 19%, 12%, 13%, and 1% at short (one month), mid-early (three months), mid-late (six months), and long-term (one year) follow-up visits, respectively. None of them were severe complications (grades IV-V), 25% were grade III, and less than 20% were low-grade complications (grades I-II).
      Overall, aesthetic satisfaction was high (90%). The total number of secondary surgeries needed to satisfy the cosmetic outcome was 20 (aesthetic POC grade IIIb). No differences regarding functional or aesthetic complication rates amongst vaginoplasty techniques were encountered. Twelve months after surgery, 81% of patients had initiated sexual intercourse, and 96% reported clitoral sensitivity.

      Conclusions

      In our experience, female genital gender affirmation surgery is a feasible, low-complication surgery that offers high satisfaction in the long term. Further multicentric well-designed research is mandatory to improve outcomes.

      Keywords

      Introduction

      Gender dysphoria (GD) is a condition that many gender diverse people experience throughout their lives, and it refers to the discomfort or distress caused by the discrepancy between their gender identity and sex assigned at birth. Genital gender confirmation surgery (genital GCS) is one of the treatment options proposed for individuals seeking care for GD, and its demand has dramatically increased in recent years. It is estimated that 1:30,000 adults assigned male at birth and 1:100,000 adults assigned female at birth seek gender confirmation surgery in Europe.
      • Labanca T.
      • Mañero I.
      Vulvar condylomatosis after sex reassignment surgery in a male-to-female transsexual: complete response to imiquimod cream.
      For transgender women, genital GCS consists of the elimination of the male sexual organs (bilateral orchiectomy and penile disassembly) and the creation of a neovagina, a glans-derived sensate clitoris, labia majora and minora, and repositioning of urethral meatus at the female anatomical site. Several genital GCS techniques performed on transgender women have been described in literature.
      • Salim A.
      • Poh M.
      Gender-affirming penile inversion vaginoplasty.
      • Claes K.E.Y.
      • Pattyn P.
      • D'Arpa S.
      • et al.
      Male-to-female gender reassignment surgery: intestinal vaginoplasty.
      • Wangjiraniran B.
      • Selvaggi G.
      • Chokrungvaranont P.
      • et al.
      Male-to-female vaginoplasty: preecha's surgical technique.
      However, there is a lack of homogeneity in terms of surgical techniques and outcome measurements regarding functional and aesthetic results.
      • Horbach S.E.R.
      • Bouman M.-.B.
      • Smit J.M.
      • et al.
      Outcome of Vaginoplasty in Male-to-Female Transgenders: a Systematic Review of Surgical Techniques.
      ,
      • Sutcliffe P.A.
      • Dixon S.
      • Akehurst R.L.
      • et al.
      Evaluation of surgical procedures for sex reassignment: a systematic review.
      As the number of performed genital GCS have increased in recent years, a peak of incidence of postoperative complications (POCs) might be expected. For valuable quality assessment, outcome data should be obtained in a standardized, objective, and reproducible manner to allow comparison amongst different centers, different therapies, and within a centre over time.
      • Dindo D.
      • Demartines N.
      • Clavien P.-.A.
      Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey.
      Our study aims to prospectively analyse the POC rate of all primary genital GCS performed on transgender women at our centre from January 2015 to December 2016, using the Clavien-Dindo
      • Clavien P.A.
      • Barkun J.
      • de Oliveira M.L.
      • et al.
      The clavien-dindo classification of surgical complications: five-year experience.
      ,
      • Mitropoulus D.
      • Artibani W.
      • Biyani C.S.
      • et al.
      Validation of the Clavien-Dindo grading system in urology by the European association of Urology guidelines ad hoc panel.
      classification measurement tool, at short (0–1 month), mid-early (1–3 months), mid-late (3–6 months), and long-term (6–12 months) periods. We divided POCs into three categories: functional (nonsensory) complications, aesthetic complications, and sensory complications. Since the primary genital GCS performed on transgender women was either inverted penile skin vaginoplasty, penoscrotal skin graft vaginoplasty, or pedicled intestinal flap vaginoplasty, our secondary objective was to compare the functional and aesthetic POC rates amongst the different aforementioned vaginoplasty techniques.

      Materials/ patients and methods

      Study design and surgical technique

      We performed a prospective observational study in which all (n = 84) consecutive transfemale individuals who underwent primary genital GCS from January 2015 to December 2016 at IMCLINIC were included, after signing informed consent and following Helsinki Declaration principles and STROBE guidelines. The research protocol was approved by the local Ethical Committee with the reference number CEEAH 5689. Exclusion criteria were transfemale individuals younger than 18 years old. The Standards of Care of the World Professional Association for Transgender Health (WPATH) (version 7) were followed as a preoperative protocol. Transfemale individuals were prospectively followed at our Gender Unit, and every deviation from the normal postoperative course was registered and graded according to the Clavien-Dindo POC classification, during hospital admission (first week after surgery), and at short (one month), mid-early (three months), mid-late (six months), and long-term (one year) follow-up outpatient visits.
      We registered and defined “functional complication” as every complication related to the new organ's functionality, besides sensorial function. Considering that one of the most important outcomes after genital GCS is the female appearance, we defined aesthetic complication as the surgical need for further cosmetic refinement. Moreover, we considered a sensory or sensitive complication the lack of clitoral sensitivity at any of the follow-up visits.
      Transwomen were seen at our outpatient clinic, where a full physical examination and medical history including basic demographics were recorded at the preoperative visit, and they were advised to discontinue hormonal treatment three weeks prior to surgery. The indication of a specific vaginoplasty technique depended mainly on penis and perineal lengths. If the surgeon considered that penile skin would be sufficient to cover the entire neovagina, inverted skin vaginoplasty was considered as a primary surgery. Otherwise, they were offered a colovaginoplasty. Peno-scrotal skin grafts were used only if, during the initial surgery with the inverted penile skin technique, more skin was needed in order to achieve adequate vaginal depth. More in detail, to determine if bowel would be used, the following measurements and/or facts were considered: Skin elasticity after penectomy (intrasurgical measurement), the presence of circumcision scar, the amount of skin (redundancy) of balanopreputial sulcus, perineal dimensions/ raphe length, scrotal skin availability, and penis length and width.
      Transfemale individuals were admitted to the hospital the day before surgery and completed a low-residue diet and bowel preparation using an oral laxative solution (phospho-soda oral solution, Casen Recordati SL, Zaragoza, Spain). On the day of surgery, and prior to any skin incision, antibiotic prophylaxis (2 g cefazolin) was administered. Patients were placed in lithotomy position, and intermittent pneumatic compression was used to prevent deep venous thrombosis.
      All surgeries were performed using the same surgical technique as described in the literature,
      • Wangjiraniran B.
      • Selvaggi G.
      • Chokrungvaranont P.
      • et al.
      Male-to-female vaginoplasty: preecha's surgical technique.
      with very few surgical changes (Figure 1). In colovaginoplasty cases, the abdomen was entered through a left para-Pfannenstiel laparotomy incision. Next, a vascular pedicle of 18–25 cm large bowel segment (generally, sigmoid) was identified and harvested in an antimesenteric direction through the vagina. The proximal portion of the pedicled bowel segment was closed using interrupted vicryl 2/0 stitches, which became the neovagina's cuff. Next, intestinal continuity was restored by end-to-end anastomosis. The length of the colon segment depended on patient's anatomical variability, height, weight, and adipose tissue, and on the length of the meso’s vascular supply that should be harvested, fixed to the promontory, and derived to the external end of the neovagina.
      Figure 1
      Figure 1Vaginoplasty technique. 1a: A neurovascular bundle flap is dissected from the tip of the penis and elevated off the tunica, keeping the glans and preputial skin for clitoral and labia minora recreation. Afterwards, glans skin and prepuce are shaped to become neoclitoris and labia minora, respectively, following Preecha's described letter “M” pattern technique
      • Wangjiraniran B.
      • Selvaggi G.
      • Chokrungvaranont P.
      • et al.
      Male-to-female vaginoplasty: preecha's surgical technique.
      (using the “v" part to recreate the clitoris and anchoring the letter "M" legs -preputial skin- at both sides of the urethral anterior flap to recreate the labia minora). 1b: The proximal 4–5 cm of urethra are used as an anteriorly-based flap attached to the pubis, which not only minimizes meatal stenosis but also creates the illusion of vulvar vestibule due to its mucosal origin. The bulbospongiosus muscle is completely removed along with the bulbous part of the urethra to prevent bulbous swelling during sexual arousal.
      Figure 2
      Figure 2Sigmoid intestinal Vaginoplasty postoperative results. 2 a: Mid-term (six month) postoperative aspect of colon mucosa recreating the neovaginal canal after sigmoid intestinal vaginoplasty. 2 b: Long-term (one year) functional and aesthetic postoperative sigmoid intestinal vaginoplasty results.
      Figure 3
      Figure 3Penile inversion vaginoplasty postoperative results. 3a: Case 1: Long-term (one-year) functional and aesthetic postoperative penile inversion vaginoplasty results. 3b, 3c, and 3d: Case 2: Long-term (one-year) functional and aesthetic postoperative penile inversion vaginoplasty results. 3e: Case 3: Long-term (one-year) functional and aesthetic postoperative penile inversion vaginoplasty results. 3f: Case 4: Long-term (one-year) functional and aesthetic postoperative penile inversion vaginoplasty results.

      Postoperative period and follow-up

      After surgery, a compressive dressing was placed in order to prevent bleeding. A Foley catheter was left in place for seven days. During this period, transwomen received antibiotic prophylaxis with ciprofloxacin 500 mg/day po and tolterodine tartrate 2 mg/day po and anticoagulants with enoxaparin 40 mg/day throughout admission. On day seven after surgery, dilation protocol was started. Transwomen were given detailed instructions about the correct technique and frequency for self-dilations, performing the first dilation before being discharged. According to our clinic's protocol, transwomen were encouraged to perform dilations by themselves, at home three times a day for the first postoperative month, twice a day from the second to the sixth postoperative months, and once a day afterwards (unless engaging in frequent penetrative sex, when they may reduce or even stop dilations).
      Follow-up visits were scheduled on the first, third, and sixth postoperative months, and after that, on an annual basis. At these appointments, the surgeon assessed if any complications were encountered and recorded them according to the Clavien-Dindo POC classification. The surgeon checked to exclude vaginal stenosis and asked about clitoral sensitivity, the initiation and frequency of sexual intercourse or use of sex toys, and aesthetic satisfaction. Regarding neoclitoral sensitivity and orgasm achievement, tactile sensitivity was evaluated by Semmes-Weinstein monofilament test
      • Selvaggi G.
      • Monstrey S.
      • Ceulemans P.
      • et al.
      Genital sensitivity after sex reassignment surgery in transsexual patients.
      in the glans clitoris. Erogenous sensitivity was evaluated by questioning the patient about the presence or absence of orgasms during any sexual practice. If any transfemale individual could not attend the follow-up visit, the surgeon either rescheduled for another date or performed a telematic follow-up visit. We evaluated the overall POC rates, emphasizing high-grade complications (Grades ≥ III) as they represent higher transfemale individual risks and higher costs.

      Statistical analysis

      The SPSS programme, version 2.0, for database and statistical analysis was used. The median and percentile 25/75 were used to describe quantitative variables. The difference between the qualitative variables was compared using the Fisher test. The quantitative variables were analysed using a nonparametric test (paired samples Wilcoxon test). All statistical tests were two-tailed. A p-value below 0.05 was considered statistically significant.

      Results

      Transwomen sample

      From January 2015 to December 2016, 84 transgender women underwent primary genital GCS at Ivan Mañero Institute of Plastic Surgery (IMCLINIC).
      These transwomen's medical history, surgical, and epidemiological characteristics are described in Table 1. The median age was 24 years (IQR 21–31). Prior to surgery, most transfemale individuals were noted to have a negative blood panel for infectious diseases. However, 2% were incidentally found to be positive for Hepatitis C and 4% for HIV. Ninety-two percent (77/84) had received hormonal treatment in the last one year (most of them with oestradiol valerate 4 mg/day and cyproterone acetate 50 mg/day). Transfemale individuals who were not under recent hormone treatment had discontinued it because of severe side effects or had decided to interrupt their hormone therapy. Twenty-five percent were smokers (21/84), and 50% of the cohort (42/84) had at least one aesthetic plastic surgery operation in the past. amongst them, augmentation mammaplasty and facial feminization were the most common performed procedures (32 and 10 patients, respectively).
      Table 1Transwomen's characteristics, surgery details, and intraoperative complications.
      Patient dataMedian (P25/ P75)n (%)
      Age (years)24 (21/31)
      Past medical history6 (7%)
      Hepatitis C2 (2%)
      HIV
      HIV = Human Immunodeficiency Virus
      3 (4%)
      Arterial hypertension1 (1%)
      Hormone treatment77 (92%)
      Smoking21 (25%)
      Surgical procedures (trans)42 (50%)
      Primary surgeryMedian (P25/ P75)n (%)
      PIV
      PIV = Penile Inversion Vaginoplasty.
      50 (60%)
      PIV with graft13 (15%)
      Colovaginoplasty21 (25%)
      Surgical times (minutes)240 (201/280)
      PIV230 (200/260)
      PIV with graft250 (225/300)
      Colovaginoplasty300 (270/309)
      Intraoperative complications11 (13%)
      Rectal injury3 (4%)
      Severe bleeding2 (2%)
      Prostate injury4 (5%)
      Inguinal hernia2 (2%)
      a HIV = Human Immunodeficiency Virus
      b PIV = Penile Inversion Vaginoplasty.

      Surgical procedure and intraoperative complications (Table 1)

      Fifty transwomen underwent vaginoplasty by inverted penile skin (60%), 13 transwomen peno-scrotal skin graft vaginoplasty (15%), and 21 patients pedicled intestinal flap vaginoplasty or colovaginoplasty (25%).
      Median surgical time was 240 min (IQR 201–280). Eleven (13%) intraoperative complications were reported (Table 1). All of them were treated during the first surgical procedure, and none of them increased the transwomen's hospital stay.

      Postoperative complications (Table 2, Table 3, Table 4, Table 5, Table 6)

      Short-Term (One-Month) follow-up

      Functional outcomes

      During the first 30 postoperative days, 16 functional POCs (19% rate) were recorded: amongst them, eight were grade II complications, one was grade IIIa, and seven were grade IIIb. amongst high-grade complications (grades III and above), one (1%) suffered postoperative ileus and needed a nasogastric tube (grade IIIa), four transwomen (5%) had haematoma requiring surgical drainage under anaesthesia (grade IIIb), one patient (1%) had a rectovaginal fistula (which was repaired in another surgery, requiring an ileostomy on discharge: complication grade IIIb “d”), and two (2%) suffered from neovaginal flap necrosis and underwent a secondary surgery with pedicled intestinal flap vaginoplasty (grade IIIb) (Table 2).
      Table 2Description of POCs
      POC = Postoperative Complication.
      at short, mid, and long-term follow-up.
      POC 1st monthn = 16/84 (19%)TreatmentPOC grade (Clavien-Dindo)POC grade n (%)
      Urethral bleeding1Compressive bandageIIII = 8 (10%)
      Abscess3Antibiotic and wound careII
      Wound dehiscence3Antibiotic and wound careII
      Psychiatric crisis1Anxiolytics and Psychiatric evaluationII
      postoperative ileus1nasogastric tubeiiiaiiia = 1 (1%)
      haematoma4surgical drainage under anaesthesiaiiibiiib = 7 (8%)
      Rectovaginal fistula1Fistula correction and ileostomyIIIb (d)
      Neovaginal necrosis2ColovaginoplastyIIIb
      POC 3rd monthn = 10/84 (12%)TreatmentPOC gradePOC grade n (%)
      Urinary infection4AntibioticsIIII = 4 (5%)
      Clitoral necrosis1Surgical repairIIIbIIIb = 6 (7%)
      Vaginal stenosis4Surgical dilationIIIb
      Ileostomy1End-to-end anastomosisIIIb
      POC 6th monthn = 11/84 (13%)TreatmentPOC gradePOC grade n (%)
      Vulvar HPV
      HPV = Human Papilloma Virus.
      1Imiquimod 2% creamIIII = 4 (5%)
      Recurrent UTI
      UTI = Urinary Tract Infection.
      3Antibiotic + Urodynamic studyII
      Vaginal stenosis7Surgical dilationIIIbIIIb = 7 (8%)
      POC 12th monthn = 1/84 (1%)TreatmentPOC gradePOC grade n (%)
      Vaginal stenosis1ColovaginoplastyIIIbIIIb = 1 (1%)
      a POC = Postoperative Complication.
      b HPV = Human Papilloma Virus.
      c UTI = Urinary Tract Infection.

      Aesthetic outcomes

      In the short-term follow-up period, we did not record the transwomen's aesthetic perception due to normal postoperative inflammation.

      Sensory function and sexual satisfaction

      A total of 74 out of 84 transwomen (88%) had clitoral sensitivity at the short-term follow-up visit (Table 6).
      All included transwomen denied having started sexual intercourse along the first postoperative month, following surgeons' recommendations.

      Mid-Term follow-up

      Mid-Early term (Three-Month) follow-up

      Functional outcomes

      At the third-month follow-up visit, 10 functional POCs were recorded (12%), corresponding to four grade II complications (5%), and six grade IIIb complications (7%) (Table 2).

      Aesthetic outcomes

      In the mid-term follow-up period, a total of eight transwomen (10%) reported aesthetic complaints, requiring another surgical intervention (Table 3).
      Table 3Functional and aesthetic POC
      POC = Postoperative Complication.
      rates at short, mid, and long-term follow-up.
      Follow-upFUNCTIONAL
      Types of functional POCs have been described in detail in Table 2.
      POC
      AESTHETIC
      Aesthetic POCs referred to the surgical necessity of revision cosmetic surgery. They were all ambulatory minor surgeries—20 surgeries; mainly labiaplasties (16 surgeries), followed by clitoroplasties (4 surgeries)—with positive outcomes.
      POC
      30 days19%-
      - = Not measured.
      3 months12%10%
      6 months13%13%
      12 months1%1%
      a POC = Postoperative Complication.
      b Types of functional POCs have been described in detail in Table 2.
      c Aesthetic POCs referred to the surgical necessity of revision cosmetic surgery. They were all ambulatory minor surgeries—20 surgeries; mainly labiaplasties (16 surgeries), followed by clitoroplasties (4 surgeries)—with positive outcomes.
      d - = Not measured.

      Sensory function and sexual satisfaction

      Results are described in Table 6.

      Mid-Late term (Six-Month) follow-up

      Functional outcomes

      At the six-month follow-up, we recorded 11 functional POCs (13%): four of them (5%) were grade II complications, and seven (8%) were grade IIIb complications. All these IIIb (high-grade) complications were vaginal stenosis that required surgical dilation (Table 2). All affected transwomen failed to accomplish the recommended regular preventive dilation regimen.

      Aesthetic outcomes

      At the six-month follow-up, 11 transwomen underwent an aesthetic refinement surgical procedure (13%) (Table 3).

      Sensory function and sexual satisfaction

      Results are detailed in Table 6.

      Long-Term (12-Month) follow-up

      Functional outcomes

      At the 12-month follow-up, one functional IIIb POC (1%) was recorded, corresponding to vaginal stenosis that required colovaginoplasty for its correction (Table 2). It is important to mention that she had undergone a surgical dilation at the sixth postoperative month and was still not complying with our recommended ambulatory self-dilation protocol.

      Aesthetic outcomes (Figures 2 and 3)

      At the 12-month follow-up, one transfemale individual required aesthetic surgical correction of the labia (1%) (Table 3).

      Sensory function and sexual satisfaction

      At the 12th postoperative month, 96% of transwomen (81/84) reported having clitoral sensitivity, while 81% (68/84) admitted to having initiated sexual intercourse (Table 6).
      Most of the transwomen reported satisfactory sexual intercourse. However, few colovaginoplasty transwomen occasionally referred to sexual intercourse-associated spastic neovaginal contractions or spasms, which are under study.

      Comparison amongst different surgical techniques

      No significant differences were found regarding functional and aesthetic POCs amongst the three different genital GCS performed techniques at any of the different follow-up time-points of the study (Tables 4 and 5).
      Table 4Functional POCs
      POC = Postoperative Complication.
      at short, mid, and long-term follow-up: Comparison amongst vaginoplasty techniques.
      Follow-upFUNCTIONAL POC
      POC = Postoperative Complication.
      (n,%)
      p value
      PIV
      PIV = Penile Inversion Vaginoplasty.
      (n = 50)
      PIV with graft (n = 13)Colovaginoplasty (n = 21)
      30 days9 (18%)2 (15%)5 (24%)0.858
      3 months4 (8%)2 (15%)4 (19%)0.321
      6 months6 (12%)2 (15%)3 (14%)0.907
      12 months01 (7%)00.133
      a POC = Postoperative Complication.
      b PIV = Penile Inversion Vaginoplasty.
      Table 5Aesthetic POCs
      POC = Postoperative Complication.
      at short, mid, and long-term follow-up: Comparison amongst vaginoplasty techniques.
      Follow-upAESTHETIC POC
      POC = Postoperative Complication.
      (n,%)
      p value
      PIV
      PIV = Penile Inversion Vaginoplasty.
      (n = 50)
      PIV with graft (n = 13)Colovaginoplasty (n = 21)
      3 months3 (18%)3 (23%)2 (9.5%)0.118
      6 months6 (12%)3 (23%)2 (9.5%)0.531
      12 months001 (4%)0.467
      a POC = Postoperative Complication.
      b PIV = Penile Inversion Vaginoplasty.
      Table 6Sensory POCs
      POC = Postoperative Complication.
      at short, mid, and long-term follow-up. Clitoral sensitivity and initiation of sexual intercourse (n = 84).
      Follow-upCLITORAL SENSITIVITY
      Meaning erogenous sensation as patient-reported experienced orgasm.
      SENSORY POC (%)Initiation of sexual intercourse n (%)
      YES (n) (%)NO (n)
      1 month741012%0
      3 months78 (92%)68%53 (63%)
      6 months80 (95%)45%62 (74%)
      12 months81 (96%)34%68 (81%)
      low asterisk Meaning erogenous sensation as patient-reported experienced orgasm.
      a POC = Postoperative Complication.

      Discussion

      At our single institution, we found less than 20% of functional POCs after female genital gender affirmation surgery. Severe life-threatening complications (Grades IV and V in the Clavien-Dindo classification) were not encountered in our cohort. However, female genital gender affirmation surgery is a complex surgery. A recent review by Claes K.E.Y. et al.
      • Claes K.E.Y.
      • Pattyn P.
      • D'Arpa S.
      • et al.
      Male-to-female gender reassignment surgery: intestinal vaginoplasty.
      describes severe complications such as necrotizing fasciitis, intestinal necrosis, bilateral lower extremity compartment syndrome, intraluminal abscess, and neoplasia after pedicled intestinal vaginoplasty. In our study, we did not find any urethral meatal stenosis, which is considered the most frequent complication after penile inversion vaginoplasty in a meta-analysis by Dreher PC et al
      • Dreher P.C.
      • Edwards D.
      • Hager S.
      • et al.
      Complications of the neovagina in male-to-female transgender surgery: a systematic review and meta-analysis with discussion of management.
      . The majority of female genital GCS POCs that were found in our cohort were labelled as grade III in the Clavien-Dindo classification and required additional repair surgery. Neovagina stenosis, one of the most prevalent complications after vaginoplasty,
      • Ferrando C.A.
      Vaginoplasty complications.
      was also found in some of our transfemale individuals (all of them corresponding to penile inversion vaginoplasties) after the third month of surgery; all cases were resolved by surgical dilation, but one had recurrence, and colovaginoplasty was performed as a secondary procedure. All neovagina stenosis complications found in our study after female genital GCS were associated with noncompliance to the self-dilation protocol regimen. In our experience, strict adherence to this protocol is mandatory for proper maintenance of neovagina diameter and length and is recommended lifelong if the transfemale individual does not have frequent penetrative sex with an anatomical phallus or other instruments/sex toys. Similar to other studies, functional nonsensory complications were the most frequent complications after female genital GCS in our cohort, followed by aesthetic complications.
      • Raigosa M.
      • Avvedimento S.
      • Yoon T.S.
      • et al.
      Male- to- female genital reassignment surgery: a retrospective review of surgical technique and complications in 60 patients.
      One of the limitations of this study was that all genital GCS were performed by a single experienced surgeon. This might be interpreted as a bias, considering that there was no surgeon variability, leading to a theoretical lower percentage of functional POCs, which could be attributed to the surgeon's experience and not to the procedure itself. On the other hand, this fact implied a homogeneous sample and methodology to ensure consistent measurements in a prospective manner, which constituted a major strength in this study. Indeed, the prospective design and objective classification outcomes tool used in this research were both advantageous, as most of the published reports on this topic are retrospective,
      • Raigosa M.
      • Avvedimento S.
      • Yoon T.S.
      • et al.
      Male- to- female genital reassignment surgery: a retrospective review of surgical technique and complications in 60 patients.
      • Rossi Neto R.
      • Hintz F.
      • Krege S.
      • et al.
      Gender reassignment surgery-a 13 year review of surgical outcomes.
      • Cristofari S.
      • Bertrand B.
      • Leuzzi S.
      • et al.
      Postoperative complications of male to female sex reassignment surgery: a 10-year French retrospective study.
      with heterogeneous techniques and nonstandardized or even subjective outcome reporting tools, and overall with scarce scientific evidence and therefore limited quality. However, proper consensus on outcomes measurement after genital GCS is still required and might be the focus of future research.
      Another limitation of our prospective study might be the short follow-up period, which was one year.
      • Lindqvist E.K.
      • Sigurjonsson H.
      • Möllermark C.
      • et al.
      Quality of life improves early after gender reassignment surgery in transgender women.
      Although the most severe complications appeared during the first postoperative months and there were only 1% of functional and aesthetic complications at the end of the first year after surgery, we plan to increase the follow-up study period in order to detect long-term complications, aiming to achieve a new analysis with this cohort of transfemale individuals in subsequent years. The short follow-up period in combination with not a large enough population size could explain why we found no statistically significant differences amongst the three vaginoplasty techniques at any of the different follow-up time points of the study. According to other authors
      • Cristofari S.
      • Bertrand B.
      • Leuzzi S.
      • et al.
      Postoperative complications of male to female sex reassignment surgery: a 10-year French retrospective study.
      ,
      • Salgado C.J.
      • Nugent A.
      • Kuhn J.
      • et al.
      Primary sigmoid vaginoplasty in transwomen: technique and outcomes.
      • Bouman M.B.
      • van Zeijl M.C.T.
      • Buncamper M.E.
      • et al.
      Intestinal vaginoplasty revisited: a review of surgical techniques, complications and sexual function.
      • Van Der Sluis W.B.
      • Bouman M.B.
      • Buncamper M.E.
      • et al.
      Revision vaginoplasty: a comparison of surgical outcomes of laparoscopic intestinal versus perineal full-thickness skin graft vaginoplasty.
      and to our 20 year long experience, intestinal vaginoplasty (especially sigmoid colovaginoplasty, which is the intestinal vaginoplasty we usually perform at our clinic) may arise as the gold standard vaginoplasty technique, but further research is necessary to shed more light on this controversial arena in the literature.
      As another limitation of our study, all our pedicled intestinal vaginoplasties were performed as open surgeries and not by laparoscopy or even robotic surgery; comparing open and laparoscopic colovaginoplasties would also be of great interest. It has been reported that total laparoscopic sigmoid vaginoplasty has lower mortality rates than open vaginoplasty,
      • Claes K.E.Y.
      • Pattyn P.
      • D'Arpa S.
      • et al.
      Male-to-female gender reassignment surgery: intestinal vaginoplasty.
      but more research on that topic is also required.
      In comparison with other published reports, to our knowledge, this is the first study to use the Clavien-Dindo classification objective tool to prospectively report female genital GCS POC rates. Other strengths of our study were the high number of surgeries performed in two consecutive years and the postoperative serial outcomes measurements at different time points of the study period, which provided information about the time-related frequency of POCs after genital GCS.
      We consider that consensus regarding the correct classification of POCs in a field that lacks standardized surgical and postoperative protocols is mandatory for quality healthcare. Furthermore, it may facilitate the evaluation and comparison of surgical outcomes amongst different surgeons, centers, and techniques, and for one single centre or surgeon throughout time. Moreover, it could also be useful for teaching and educational purposes.

      Conclusion

      At our single institution, we found less than 20% of functional POCs after female genital GCS at short, mid, and long-term follow-up periods. Aesthetic complications were reported in less than 15% of the cases. At 12 months postop, only 1% of the transwomen reported functional or aesthetic complications, with initiation of satisfactory sexual intercourse in most transwomen and restored clitoral sensory function in 96% of them. In our prospective cohort, we did not find any differences in functional or aesthetic POC rates between the three offered female genital GCS; that is, penile skin vaginoplasty, penoscrotal skin graft vaginoplasty, and pedicled intestinal flap vaginoplasty. In our experience, female genital GCS is a feasible, low-complication surgery that offers high transwoman satisfaction in the long-term.
      Establishing a standardized validated tool for measuring postoperative POCs after genital GCS may increase scientific evidence to compare and standardize surgical procedures and outcomes worldwide in genital GCS, limiting healthcare costs and improving medical care. Further well-designed research is strongly required to provide new updated efficient evidence-based clinical guidelines to improve the quality of life of transgender and gender diverse people.

      Declaration of Competing Interest

      None declared.

      Funding

      None.

      Ethical approval

      The research protocol was approved by the local Ethical Committee with the reference number CEEAH 5689.
      Research informed consent and Photo Patient Consent was obtained.

      Acknowledgements

      The authors acknowledge all professionals at IMCLINIC and especially all transwomen who participated in this research, as well as their families for their continuing support.

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