Bowel, Urinary and Sexual Function After Laparoscopic Colorectal Surgery

April 14, 2010 updated by: Kyoto University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

36

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Kyoto, Japan, 606-8507
        • Kyoto University hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Probability Sample

Study Population

Male patients who will receive laparoscopic colorectal surgery

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kyoto University

Investigators

  • Study Chair: Yoshiharu Sakai, Professor, Kyoto University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2007

Primary Completion (Actual)

April 1, 2010

Study Completion (Actual)

April 1, 2010

Study Registration Dates

First Submitted

March 22, 2007

First Submitted That Met QC Criteria

March 22, 2007

First Posted (Estimate)

March 23, 2007

Study Record Updates

Last Update Posted (Estimate)

April 15, 2010

Last Update Submitted That Met QC Criteria

April 14, 2010

Last Verified

January 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E-282

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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