Viewing Study NCT00451165



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Study NCT ID: NCT00451165
Status: COMPLETED
Last Update Posted: 2010-04-15
First Post: 2007-03-22

Brief Title: Bowel Urinary and Sexual Function After Laparoscopic Colorectal Surgery
Sponsor: Kyoto University
Organization: Kyoto University Hospital

Study Overview

Official Title: Outcome Study of Bowel Urinary and Sexual Function After Laparoscopic Colorectal Surgery Using Questionnaire and Function Tests
Status: COMPLETED
Status Verified Date: 2009-01
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief 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
Detailed 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 SF8International Consultation on Incontinence Questionnaire-Short FormICIQ-SFInternational Prostate Symptom ScoreIPSSGastro-Intestinal Functional OutcomeGIFO and function tests uroflowmetry and US

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None