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ID
Source
Brief title
Health condition
genderdysphoria
Sponsors and support
Intervention
Outcome measures
Primary outcome
Major and minor complications during, directly after, within 6 weeks or within 3 months after surgery.Complications that are expected as part of this outcome are:
Subcutaneous insufflation; urinary tract injury; intestinal injury; conversion to vaginal surgery; haemorrhage (bloodloss >1000ml); urinary tract infection; urinary retention; fistula; wound infection; fever eci
Secondary outcome
Surgical outcomes: blood loss, surgery time, console time
Post-surgery outcomes: hospital stay, need for prolonged catheterisation, and/or clean intermittend intermittent catheterization (the patient catheterizes himself) because of post voiding residue after surgery
IPSS* and uroflowmetry (pre and postoperative)
Patient outcomes: quality of life (SF36), satisfaction
Background summary
During sex change surgery from female-to-male a colpectomy (removal of the vagina) is performed to lower the risk of complications after phallo- or metadoioplastic (the surgical addition of a penis) with urethral lengthening. Until recently, the colpectomy was performed vaginally after the removal of the uterus. Recently, we have described a robot-assisted laparoscopic method to remove the uterus and vagina in one surgery. We have seen a drastic decrease in complications comparing the vaginal colpectomy with the robot-assisted laparoscopic colpectomy combined with hysterectomy (the extended colpectomy). But until now, transmen who had their uterus already removed had only one option: vaginal colpectomy. Yet, it is possible to perform a robot-assisted laparoscopic colpectomy after hysterectomy (the single colpectomy) and this is performed in New York already. With this pilot study we will determine 1) feasibility of the robot-assisted laparoscopic single colpectomy and 2) ethical accountability of a future randomised controlled trial comparing vaginal colpectomy with the single robot-assisted laparoscopic colpectomy.
Study objective
Previous studies show that the robot-assisted laparoscopic, extended colpectomy has lower risks on surgical complications. Therefore, we hypothese that single colpectomy will also lower the risks for the participating patient.
Study design
- Perioperatively; - 6 weeks & 3months postopertively
Intervention
Robot-assisted laparoscopic colpectomy
Inclusion criteria
- age 18-80
- female-to-male transgender
- indication for colpectomy (urethral lengthening, vaginal dysphoria, complaints as vaginal discharge)
- previous hysterectomy
Exclusion criteria
- colpectomy because of other reasons then gender dysphoria
- contra-indication for laparoscopic surgery
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| NTR-new | NL9303 |
| Other | Amsterdam UMC : 2021.0062 |