Methods
Protocol and
guidance
This review was conducted in accordance to Preferred Reporting Items for
Systematic Reviews and Meta-Analysis (PRISMA)
guidelines.46 The protocol was registered (May 19,
2021) in PROSPERO (CRD42021249785).
Eligibility criteria
Studies had to meet all inclusion criteria : (i) original paper
on surgical, complete neovagina creation; (ii) written in English; (iii)
a peer reviewed journal publication; (iv) discuss anatomical outcome,
Quality of Life, satisfaction, sexual functioning, complications and/or
complaints; (v) ≥ 6 months Follow Up; (vi) patients ≥ 18 years during
surgery; (vii) and ≥ 10 MRKHS patients or transwomen. Study exclusion
for one or more satisfied Exclusion criteria : (i) unspecified
surgical technique, vaginoplasty combined with other treatment or as
non-primary surgery; (ii) merged results of patient and control group or
of different patient types; (iii) or merged results of different
vaginoplasty techniques.
Search
strategy
A strategic, three-step search was performed in bibliographic databases
Medline, EMBASE, Web of Science and Scopus (Core Collection) by a
medical information specialist (R.d.V.), to identify relevant
publications up to March 8, 2022. This PICO-search with (MeSH) terms
(including synonyms and closely related words), looked forTransgender persons and MRKH patients (P articipants),Sex reassignment surgery and vaginoplasty(I ntervention), and neovagina combined with anatomy,
satisfaction, sexual function, Quality of Life, complaints or
complications (O utcome). Next, references were screened
(‘snowball’ method) and a ‘related search’ on initial 200 Google Scholar
hits was performed by a PhD candidate (J.S.). Duplicates were removed
and a Mendeley 1.19.4 (Mendeley Ltd.) database was formed. The searches
are included (Figure S12).
Study
selection
Two researchers (J.S. and F.G.) independently screened titles and
abstract for eligibility criteria using EndNote Library 20.1, with with
discrepancies resolved by a third reviewer. Remaining articles were
assessed independently for full content. Disagreements were resolved
through discussion between the two authors.
Data
extraction
Data from included studies was extracted according to a predefined
standard. Neovagina lengths and operation times were pooled per surgical
technique. Complications were reported as number of events and
categorized hemorrhagic (transfusion and hematoma), gastrointestinal
(rectal injury and recto-vaginal fistula), vaginal prolapse, tissue
necrosis (of urethra, glans, clitoris and labia), (meatal or neovaginal)
stenosis and revisions. Complaints included excessive mucous production,
(genital) pain, (vaginal) hair growth, fecal- and urinary issues.
Patient-reported satisfaction with anatomy and aesthetics, overall
dissatisfaction and experienced regret were assessed. Sexual function
included dyspareunia (pain during intercourse), experienced (erotic and
orgasmic) sensation, sexual activity and satisfactory-graded sex life.
Standardized questionnaires for aesthetics (Female Genital Self-Image
Scale; FGSIS) and QoL were assessed separately and not included in the
meta-analysis. Information was correlated and presented.
Risk of bias and quality of
evidence
Methodological quality, for
critical evaluation and not for methodological
filtering,47,48 of included studies was assessed
through the Newcastle Ottawa Scale (NOS).49 Potential
bias was identified through the National Heart, Lung, and Blood
Institute (NIH) Study Quality Assessment Tool for Observational Cohort
and Cross-sectional Studies11Checklist at
www.nhlbi.nih.gov/health-topics/study-quality-assessment-tools..
Data
synthesis
By statistical analysis in Stata version 14.0 (StataCorp LLC, College
Station, TX), operation times and anatomy were pooled by metan ,
with 95% confidence interval (CI) and effect size calculation by
DerSimonian and Laird random-effects.50 Complications,
complaints, satisfaction and sexual function were pooled bymetaprop , with 95% Wilson CI and DerSimonian and Laird
random-effects,51 after variance stabilization by
Freeman-Tukey double-arcsine-transformation and heterogeneity
determination by I-square measures.52