Bowel, Urinary and Sexual Function After Laparoscopic Colorectal Surgery

Colorectal Surgery Clinical Trial

Official title:

Outcome Study of Bowel, Urinary and Sexual Function After Laparoscopic Colorectal Surgery, Using Questionnaire and Function Tests

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00451165
• Other study ID #: E-282
• Status: Completed
• Phase: N/A
• First received: March 22, 2007
• Last updated: April 14, 2010
• Start date: May 2007
• Est. completion date: April 2010

Study information

• Verified date: January 2009
• Source: Kyoto University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

Research Populations: Male patients scheduled for laparoscopic colorectal surgery

Study Method: Questionnaire and function tests

Hypothesis: A laparoscopic nerve-sparing operation is not inferior to reported open surgery in preserving urinary and sexual function.

Description:

There have been some reports that laparoscopically assisted rectal resection is associated with a higher rate of male sexual dysfunction compared with the open approach. But these reports are studied retrospectively.

We examine the frequency of bowel, urinary and sexual dysfunction prospectively in patients who received laparoscopic colorectal surgery.

We examine before operation, 7 days after, 3 months after, 6 months after and 12 months after operation, by questionnaires (International Index of Erectile Function (IIEF) 、Short Form-8 (SF8)、International Consultation on Incontinence Questionnaire-Short Form(ICIQ-SF)、International Prostate Symptom Score(IPSS)、Gastro-Intestinal Functional Outcome(GIFO)) and function tests (uroflowmetry and US).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: April 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

• Male

• Laparoscopic right colon resection/laparoscopic rectal surgery

• 20-80 years old

• ECOG performance status (PS) 0-2

Exclusion Criteria:

• Emergent operation

• Previous proctectomy

• Severe urinary dysfunction

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Colorectal Surgery
• Sexual Dysfunction, Physiological
• Surgery, Laparoscopic

Intervention

Procedure:
• laparoscopic colorectal surgery
laparoscopic colorectal surgery

Locations

Country	Name	City	State
Japan	Kyoto University Hospital	Kyoto

Sponsors (1)

Lead Sponsor	Collaborator
Kyoto University

Country where clinical trial is conducted

Japan,