NCT00451165

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2007

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 22, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 23, 2007

Completed
1 month until next milestone

Study Start

First participant enrolled

May 1, 2007

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
Last Updated

April 15, 2010

Status Verified

January 1, 2009

Enrollment Period

2.9 years

First QC Date

March 22, 2007

Last Update Submit

April 14, 2010

Conditions

Surgery, LaparoscopicSexual Dysfunction, PhysiologicalColorectal Surgery

Keywords

LaparoscopicColonRectalSurgeryUrinary functionSexual functionBowel functionMale

Study Arms (2)

colon

Procedure: laparoscopic colorectal surgery

rectum

Procedure: laparoscopic colorectal surgery

Interventions

laparoscopic colorectal surgeryPROCEDURE

laparoscopic colorectal surgery

Also known as: endoscopic surgery
colonrectum

Eligibility Criteria

Age20 Years - 80 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Male patients who will receive laparoscopic colorectal surgery

You may qualify if:

  • Male
  • Laparoscopic right colon resection/laparoscopic rectal surgery
  • years old
  • ECOG performance status (PS) 0-2

You may not qualify if:

  • Emergent operation
  • Previous proctectomy
  • Severe urinary dysfunction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kyoto University Hospital

Kyoto, Kyoto, 606-8507, Japan

Location

MeSH Terms

Conditions

Sexual Dysfunction, Physiological

Interventions

Endoscopy

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, SurgicalDiagnostic Techniques and ProceduresDiagnosisMinimally Invasive Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Yoshiharu Sakai, Professor

    Kyoto University Hospital

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 22, 2007

First Posted

March 23, 2007

Study Start

May 1, 2007

Primary Completion

April 1, 2010

Study Completion

April 1, 2010

Last Updated

April 15, 2010

Record last verified: 2009-01

Locations

JP(1)