Surgery, LaparoscopicNCT00451165
Bowel, Urinary and Sexual Function After Laparoscopic Colorectal Surgery
An observational study of Surgery, Laparoscopic and Sexual Dysfunction, Physiological, run by Kyoto University at 1 site in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 80 years, men only
- Conditions the study is for
- Surgery, Laparoscopic, Sexual Dysfunction, Physiological, Colorectal Surgery
- What is being tested?
- laparoscopic colorectal surgery
- Type of treatment
- Surgery or procedure
- How many people
- 36 participants
- Where
- 1 siteJapan
- Study dates
- May 2007to Apr 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Male patients who will receive laparoscopic colorectal surgery
Who may be able to join
- Male
- Laparoscopic right colon resection/laparoscopic rectal surgery
- 20-80 years old
- ECOG performance status (PS) 0-2
Who cannot join
- Emergent operation
- Previous proctectomy
- Severe urinary dysfunction
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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).
- Being tested
- laparoscopic colorectal surgery
- Keywords
- Laparoscopic, Colon, Rectal, Surgery, Urinary function, Sexual function, Bowel function, Male
- Medical subject headings
- Sexual Dysfunction, Physiological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laparoscopic colorectal surgeryProcedure or surgery
Also called endoscopic surgery
laparoscopic colorectal surgery
| Study group | Role | What they receive |
|---|---|---|
| colon | Not described Receives: Procedure: laparoscopic colorectal surgery | |
| rectum | Not described Receives: Procedure: laparoscopic colorectal surgery |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2007 (estimated)
- Study startMay 2007
- Primary completionApr 2010
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgery, LaparoscopicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kyoto University
- Sponsor type
- University, hospital or other
- Investigators
- Yoshiharu Sakai, Professor, Study chair, Kyoto University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00451165
- Sponsor's protocol ID
- E-282
- Status last verified
- Jan 2009
- First submitted
- 22 Mar 2007
- Last updated
- 15 Apr 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome Study of Bowel, Urinary and Sexual Function After Laparoscopic Colorectal Surgery, Using Questionnaire and Function Tests
- ClinicalTrials.gov ID
- NCT00451165
- Acronym / sponsor ID
- E-282
- Keywords
- Laparoscopic, Colon, Rectal, Surgery, Urinary function, Sexual function, Bowel function, Male
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Kyoto UniversityUniversity, hospital or other
- Study start
- May 2007
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 23 Mar 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 (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
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| colon | – | Procedure: laparoscopic colorectal surgery |
| rectum | – | Procedure: laparoscopic colorectal surgery |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Male patients who will receive laparoscopic colorectal surgery
Key inclusion criteria (4 listed)
- Male
- Laparoscopic right colon resection/laparoscopic rectal surgery
- 20-80 years old
- ECOG performance status (PS) 0-2
Key exclusion criteria (3 listed)
- Emergent operation
- Previous proctectomy
- Severe urinary dysfunction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| laparoscopic colorectal surgeryAlso: endoscopic surgerylaparoscopic colorectal surgery | Procedure or surgery | colon, rectum |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yoshiharu Sakai, Professor study chair
Kyoto University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Surgery, Laparoscopic and Sexual Dysfunction, Physiological, run by Kyoto University at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Apr 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2010; AzTrials last refreshed its copy on 31 Oct 2026.