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ID
Source
Brief title
Health condition
Ulcerative colitis
Restorative proctocolectomy
Ileo pouch anal anastomosis
Sexual function
Colitis Ulcerosa
Proctocolectomie
Ileo anale pouch
Seksueel functioneren
Sponsors and support
Department of Surgery
Intervention
Outcome measures
Primary outcome
Primary study endpoints are the difference in VPA pre- and postoperatively for the close rectal group and the difference in VPA pre- and postoperatively for the close rectal and the TME groups compared.
Secondary outcome
Secondary endpoints are differences in feelings of sexual arousal and estimated lubrication pre- and postoperatively and difference in psychological- and sexual functioning pre- and postoperatively for the close rectal group and for the close rectal and the TME groups compared. These outcomes will be measured by means of the Subjective Self-Assessment Questionnaire (SSAQ), Female Sexual Function Index (FSFI), Female Sexual Distress Scale (FSDS), Short Form-36 (SF-36), Beck Depression Inventory (BDI) and Maudsley Marital Questionnaire (MMQ). Our other study parameters will include age, American Society of Anesthesiologists (ASA) classification, Body Mass Index (BMI), operating time, type of surgery (i.e. IPAA or IPAA with protecting loop ileostomy).
Background summary
Rationale:
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.
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, performed in the Netherlands. Pre- and postoperative data will be compared with data from the earlier Plexlab study.
Study population:
Adult female patients with UC and an indication for restorative proctocoletomy or completion proctectomy with IPAA.
Intervention:
VPA measurements in the experimental laboratory of the department of Sexology.
Main study parameters/endpoints:
Primary endpoint is the difference in VPA pre- and postoperatively. 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.
Study objective
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, now commonly used in our centre, 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 design
Patients will have one preoperative visit to the sexology outpatient clinic, where VPA measurement will take place and the questionnaires will be filled out. This will take place approximately 4 weeks preoperatively. The same measurement will be repeated one more time approximately 9 months postoperatively.
Intervention
This study is a comparative clinical study in which a group of female patients will undergo close rectal restorative proctocolectomy or completion proctectomy with IPAA. Pre- and postoperatively the patients will undergo vaginal pulse amplitude (VPA) measurements and fill out a set of questionnaires. Patient data will be compared with the patient data of the earlier Plexlab study, in which 11 patients underwent TME restorative prococolectomy or completion proctectomy with ileo anal pouch anastomosis.
Department of Surgery<br>
Meibergdreef 9
S.A.L. Bartels
Amsterdam 1105 AZ
The Netherlands
+31 (0)20 5663170
s.a.bartels@amc.uva.nl
Department of Surgery<br>
Meibergdreef 9
S.A.L. Bartels
Amsterdam 1105 AZ
The Netherlands
+31 (0)20 5663170
s.a.bartels@amc.uva.nl
Inclusion criteria
1. Female patients;
2. >17 years and pre menopausal;
3. Ulcerative colitis;
4. Scheduled for elective restorative procotocolectomy with IPAA; or;
5. Scheduled for completion proctectomy with IPAA.
Exclusion criteria
1. Previous bowel resections other than emergency colectomy;
2. Previous surgery on genitalia;
ï€3. Non elective surgery;
4. Severe postoperative complications (e.g. anastomotic leakage, abscess, peritonitis);
5. ï€Use of medication that might influence the sexual response (psychopharmaca, antihypertensives);
6. ï€Diabetes Mellitus;
7. ï€Depression (measured by Beck Depression Inventory (BDI)- Scale);
8. ï€History of sexual abuse;
9. ï€Pre-existence of sexual dysfunction.
Design
Recruitment
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 | NL2714 |
NTR-old | NTR2852 |
Other | METC AMC : 10/257 |
ISRCTN | ISRCTN wordt niet meer aangevraagd. |