feasability of a robot-assisted laparoscopic, single colpectomy in female-to-male transgenders who already had their uterus removed.
ID
Source
Brief title
Condition
- Vulvovaginal disorders (excl infections and inflammations)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Surgical complications during, right after or within 6 weeks after surgery and
long-term complications 3 months after surgery.
Secondary outcome
Voiding function, quality of life and experience after the surgery
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
feasability of a robot-assisted laparoscopic, single colpectomy in
female-to-male transgenders who already had their uterus removed.
Study design
a pilot cohort study comparing complication outcomes with a cohort of vaginal,
single colpectomy patients from a study.
Intervention
A robot-assisted laparoscopic, single colpectomy
Study burden and risks
The burden are laparoscopic incisions (vaginal surgery does not create any
abdominal scars) and time investment in filling out questionnaires of an
expected 20 minutes. 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.
Boelelaan 1117
Amsterdam 1081 HV
NL
Boelelaan 1117
Amsterdam 1081 HV
NL
Listed location countries
Age
Inclusion criteria
- 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
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL75085.029.20 |