Methods
Protocol and
guidance
This review was conducted in accordance to Preferred Reporting Items for
Systematic Reviews and Meta-Analysis (PRISMA)
guidelines30 and registered (May 19, 2021) in PROSPERO
(CRD42021249785).
Eligibility criteria
Inclusion criteria : (i) original paper on surgical, complete
neovagina creation; (ii) English; (iii) peer reviewed publication; (iv)
discuss anatomy with complications, complaints, satisfaction, sexual
functioning or Quality of Life; (v) ≥ 6 months Follow Up; (vi) ≥ 10
MRKH- or MtF-patients of (vii) ≥ 18 years during surgery.
Exclusion criteria : (i) unspecified technique, vaginoplasty as
non-primary (or combined with other) treatment; (ii) merged results of
patient types and/or control group; (iii) or merged vaginoplasty
technique results.
Search
strategy
A strategic, bibliography search in Medline, EMBASE, Web of Science and
Scopus was performed by a medical information specialist (R.d.V.), on
publications up to October 6, 2022 (Figure S1). The PICO-search (with
MeSH and closely related terms), looked for Transgender personsand MRKH-patients (P articipants), Sex reassignment
surgery and vaginoplasty (I ntervention), andneovagina combined with anatomy , complications ,complaints , satisfaction , sexual function orQuality of Life (O utcome). The reference ‘snowballing’
method and a Google Scholar search on initial 200 hits were performed
(J.S.). A Mendeley 1.19.4 database was formed after duplicate removal.
Study
selection
Two researchers (J.S. and F.G.) screened titles and abstract for
eligibility with EndNote 20.1 and assessed remaining articles
independently for full content. Discrepancies were resolved with a third
reviewer (J.H.).
Data
extraction
Data from included studies were extracted according to a predefined
standard. Neovagina depth and surgery duration were pooled per surgical
technique. Quantity of reported complications and complaints were
categorized as hemorrhage (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 and excessive mucous production, (genital) pain,
(vaginal) hair growth, fecal- and urinary issues with Clavien-Dindo
classification.31,32 Patient-reported anatomical and
aesthetic satisfaction, overall dissatisfaction and experienced regret
were assessed. Sexual function included dyspareunia, experienced (erotic
and orgasmic) sensation, sexual activity (sexually active patients) and
satisfactory-graded sex life. Standardized questionnaires for aesthetics
(Female Genital Self-Image Scale; FGSIS) and Quality of Life (QoL) were
assessed but not included in the meta-analysis.
Risk of bias and quality of
evidence
Methodological quality of included
studies was assessed without filtering33,34 by the
Newcastle Ottawa Scale (NOS).35 Potential bias was
identified through the National Heart, Lung, and Blood Institute (NIH)
Study Quality Assessment Tool for Observational Cohort and
Cross-sectional Studies.11Checklist 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), surgery duration and anatomy were pooled bymetan , with 95% confidence interval (CI) and DerSimonian and
Laird random-effect size calculation.36 Complications,
complaints, satisfaction and sexual function were pooled bymetaprop , with 95% Wilson CI and DerSimonian and Laird
random-effects,37 after variance stabilization by
Freeman-Tukey double-arcsine-transformation and heterogeneity
determination by I-square measures.38