To assess whether close rectal restorative proctocolectomy with IPAA has a better outcome regarding postoperative vaginal vasocongestion and reported psychological and sexual functioning then IPAA by TME restorative proctocolectomy.
ID
Source
Brief title
Condition
- Gastrointestinal inflammatory conditions
- Sexual function and fertility disorders
- Gastrointestinal therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary endpoint is the difference in VPA pre- and postoperatively. The results
are compared to those of the Plexlab study.
Secondary outcome
Secondary endpoints are differences in feelings of sexual arousal and estimated
lubrications pre- and postoperatively and difference in psychological- and
sexual functioning pre- en postoperatively. The results are compared to those
of the Plexlab study.
Background summary
Standard treatment for patients with refractory Ulcerative Colitis (UC) is
restorative proctocolectomy with ileo pouch anal anastomosis (IPAA). Sexual
dysfunction after IPAA is common. The most systematic physical reaction to
sexual stimulation is an increase in vaginal vasocongestion. This genital
response can be assessed using vaginal photoplethysmography. The Plexlab study
reported on 11 patients undergoing IPAA by total mesorectal excision (TME)
technique. A significant reduction in vaginal vasocongestion during sexual
stimulation postoperatively was reported. Subjective sexual arousal and
lubrication during the experiment and reported psychological and sexual
functioning pre- and postoperatively were similar. A different surgical
technique, the *close rectal* dissection, spares the mesorectum, thereby
preserving small nerve fibers. We hypothesize that the close rectal technique
leads to a better vaginal vasocongestion postoperatively than TME technique.
Study objective
To assess whether close rectal restorative proctocolectomy with IPAA has a
better outcome regarding postoperative vaginal vasocongestion and reported
psychological and sexual functioning then IPAA by TME restorative
proctocolectomy.
Study design
A single-centre comparative clinical study. Pre- and postoperative data will be
compared with data from the earlier Plexlab study
Study burden and risks
Patients will have to bring 2 preoperative visits to the experimental
laboratory of the department of Sexology. During the first visit the patient
will be introduced to the laboratory where the VPA measurements will be
demonstrated. In addition, a set of questionnaires must be completed. The
second visit will include the VPA measurements during visual and vibrotactile
sexual stimulation. Postoperatively the patient will bring one more visit to
the laboratory, where the VPA measurements will be repeated and another set of
questionnaires will be filled out. There is no risk or benefit involved for the
patients.
Meibergdreef 9
1100 DD Amsterdam Zuidoost
NL
Meibergdreef 9
1100 DD Amsterdam Zuidoost
NL
Listed location countries
Age
Inclusion criteria
Female patients
>17 years and pre menopausal
Ulcerative colitis
Scheduled for elective restorative procotocolectomy with IPAA; or
Scheduled for completion proctectomy with IPAA
Exclusion criteria
*Previous bowel resections other than emergency colectomy
Previous surgery on genitalia
Non elective surgery
Severe postoperative complications (e.g. anastomotic leakage, abscess, peritonitis)
Use of medication that might influence the sexual response (psychopharmaca, antihypertensives)
Diabetes Mellitus
Depression (measured by Beck Depression Inventory (BDI)- Scale)
History of sexual abuse
Pre-existence of sexual dysfunction
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 | NL34346.018.10 |