Bowel, Urinary and Sexual Function After Laparoscopic Colorectal Surgery

NCT ID: NCT00451165

Last Updated: 2010-04-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

36 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-05-31

Study Completion Date

2010-04-30

Brief Summary

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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

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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).

Conditions

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Surgery, Laparoscopic Sexual Dysfunction, Physiological Colorectal Surgery

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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colon

laparoscopic colorectal surgery

Intervention Type PROCEDURE

laparoscopic colorectal surgery

rectum

laparoscopic colorectal surgery

Intervention Type PROCEDURE

laparoscopic colorectal surgery

Interventions

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laparoscopic colorectal surgery

laparoscopic colorectal surgery

Intervention Type PROCEDURE

Other Intervention Names

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endoscopic surgery

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Kyoto University

OTHER

Sponsor Role lead

Principal Investigators

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Yoshiharu Sakai, Professor

Role: STUDY_CHAIR

Kyoto University Hospital

Locations

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Kyoto University Hospital

Kyoto, Kyoto, Japan

Site Status

Countries

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Japan

Other Identifiers

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E-282

Identifier Type: -

Identifier Source: org_study_id

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