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

Genital and subjective sexual response in women after close rectal restorative proctocolectomy with ileal pouch anal anastomosis: A comparative clinical study.

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON29187

Enrollment

Registered

2011-04-13

Start date

2011-01-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ulcerative colitis Restorative proctocolectomy Ileo pouch anal anastomosis Sexual function Colitis Ulcerosa Proctocolectomie Ileo anale pouch Seksueel functioneren

Interventions

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 p

Eligibility

Inclusion criteria

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

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 outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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).	—

Measure

Time frame

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).

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Contacts

Public ContactS.A.L. Bartels

Academic Medical Center Department of Surgery Meibergdreef 9

s.a.bartels@amc.uva.nl+31 (0)20 5663170

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)