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Bowel, Urinary and Sexual Function After Laparoscopic Colorectal Surgery

This study has been completed.
Sponsor:
Information provided by:
Kyoto University
ClinicalTrials.gov Identifier:
NCT00451165
First received: March 22, 2007
Last updated: April 14, 2010
Last verified: January 2009
History of Changes
  Purpose

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.


Condition Intervention
Surgery, Laparoscopic
Sexual Dysfunction, Physiological
Colorectal Surgery
 Procedure: laparoscopic colorectal surgery

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Outcome Study of Bowel, Urinary and Sexual Function After Laparoscopic Colorectal Surgery, Using Questionnaire and Function Tests

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Kyoto University:

Enrollment: 36
Study Start Date: May 2007
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
colon Procedure: laparoscopic colorectal surgery
laparoscopic colorectal surgery
Other Name: endoscopic surgery
rectum Procedure: laparoscopic colorectal surgery
laparoscopic colorectal surgery
Other Name: endoscopic surgery

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 (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).

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Male patients who will receive laparoscopic colorectal surgery

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00451165

Locations
Japan
Kyoto University Hospital
Kyoto, Japan, 606-8507
Sponsors and Collaborators
Kyoto University
Investigators
Study Chair: Yoshiharu Sakai, Professor Kyoto University
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00451165     History of Changes
Other Study ID Numbers: E-282
Study First Received: March 22, 2007
Last Updated: April 14, 2010
Health Authority: Japan: Institutional Review Board

Keywords provided by Kyoto University:
Laparoscopic
Colon
Rectal
Surgery
 Urinary function
Sexual function
Bowel function
Male

Additional relevant MeSH terms:
Sexual Dysfunctions, Psychological
Sexual Dysfunction, Physiological
Sexual and Gender Disorders
 Mental Disorders
Genital Diseases, Male
Genital Diseases, Female

ClinicalTrials.gov processed this record on May 21, 2013