Effects on anorectal, urogenital and sexual functioning of operations of the rectum

Recruiting

• Conditions: C20; K51.0; Malignant neoplasm of rectum; Ulcerative (chronic) pancolitis

• Registration Number: DRKS00018082
• Lead Sponsor: Charité Campus Benjamin Franklin

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-03-08
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

adenocarcinoma of the rectum, 0-16 cm measured from anocutaneous line with histological proof. Planned operation with low anterior resection
or
intersphincteric resction by proven colitis ulcerosa

Age = 18 y

Exclusion Criteria

radiatio of pelvic region in medical history
metastasized or high grade carcinoma without surgical therapy
missing capacity of consent
complete urinary incontinence
complete fecal incontinence
familial adenomatous polyposis- associated carcinoma of rectum
emergency operations
rectal extirpation
operation without primary restored continuity

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in maximum urinary flow measured by uroflowmetry.

Secondary Outcome Measures

Name	Time	Method
deterioration of anorectal function measured by EORTC QLQ - C30 and -CR 29<br>function of pelvic muscles measured by Multiple Array Probe Leiden (MAPLe)<br>urogenital function measured by Uroflowmetry, International Consultation of Incontinence Questionnaire (ICIQ)<br>sexual function measured by Female Sexual Function Index (FSFI), International Index of Eredtile Function (IIEF), Derogatis Interview for Sexual Functioning (DISF)