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Sexual function after 'close rectal' ileo-anal pouch.


- candidate number9332
- NTR NumberNTR2852
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR13-apr-2011
- Secondary IDs10/257 METC AMC
- Public TitleSexual function after 'close rectal' ileo-anal pouch.
- Scientific TitleGenital and subjective sexual response in women after close rectal restorative proctocolectomy with ileal pouch anal anastomosis: A comparative clinical study.
- ACRONYMPLEXLAB 2
- hypothesisThe 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.
- Healt Condition(s) or Problem(s) studiedProctocolectomy, Ulcerative Colitis, Ileo pouch anal anastomosis, Sexual function
- Inclusion criteria1. 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 criteria1. Previous bowel resections other than emergency colectomy;
2. Previous surgery on genitalia;
3. Non elective surgery;
4. Severe postoperative complications (e.g. anastomotic leakage, abscess, peritonitis);
5. Use of medication that might influence the sexual response (psychopharmaca, antihypertensives);
6. Diabetes Mellitus;
7. Depression (measured by Beck Depression Inventory (BDI)- Scale);
8. History of sexual abuse;
9. Pre-existence of sexual dysfunction.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-jan-2011
- planned closingdate1-jun-2013
- Target number of participants18
- InterventionsThis 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.
- Primary outcomePrimary 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 outcomeSecondary 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).
- TimepointsPatients 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.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES S.A.L. Bartels
- CONTACT for SCIENTIFIC QUERIESProf. Dr. W.A. Bemelman
- Sponsor/Initiator Academic Medical Center (AMC), Department of Surgery
- Funding
(Source(s) of Monetary or Material Support)
Academic Medical Center (AMC)
- PublicationsN/A
- Brief summaryRationale:
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.
- Main changes (audit trail)
- RECORD13-apr-2011 - 25-apr-2011


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