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Bowel, Urinary and Sexual Function After Laparoscopic Colorectal Surgery

Sponsor
Kyoto University (Other)
Overall Status
Completed
CT.gov ID
NCT00451165
Collaborator
(none)
36
Enrollment
1
Location
35
Duration (Months)
1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: laparoscopic colorectal 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).

Study Design

Study Type:
Observational
Actual Enrollment :
36 participants
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
Study Start Date :
May 1, 2007
Actual Primary Completion Date :
Apr 1, 2010
Actual Study Completion Date :
Apr 1, 2010

Arms and Interventions

Arm Intervention/Treatment
colon

Procedure: laparoscopic colorectal surgery
laparoscopic colorectal surgery
Other Names:
  • endoscopic surgery

    		•
    rectum

    Procedure: laparoscopic colorectal surgery
    laparoscopic colorectal surgery
    Other Names:
  • endoscopic surgery

    		•

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      20 Years to 80 Years
      Sexes Eligible for Study:
      Male
      Accepts Healthy Volunteers:
      No
      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

      Locations

      Site City State Country Postal Code
      1 Kyoto University Hospital Kyoto Japan 606-8507

      Sponsors and Collaborators

      • Kyoto University

      Investigators

      • Study Chair: Yoshiharu Sakai, Professor, Kyoto University

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      , ,
      ClinicalTrials.gov Identifier:
      NCT00451165
      Other Study ID Numbers:
      • E-282
      First Posted:
      Mar 23, 2007
      Last Update Posted:
      Apr 15, 2010
      Last Verified:
      Jan 1, 2009
      Keywords provided by , ,
      Laparoscopic
      Colon
      Rectal
      Surgery
      Urinary function
      Sexual function
      Bowel function
      Male
      Additional relevant MeSH terms:
      Sexual Dysfunction, Physiological

      Study Results

      No Results Posted as of Apr 15, 2010