NCT01125111

Brief Summary

The clinical study of making the evidence with application of Da vinci-Robot assisted low anterior resection in rectal cancer

Trial Health

100
On Track

Trial Health Score

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

Enrollment
69

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2009

Shorter than P25 for all trials

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

Study Start

First participant enrolled

June 1, 2009

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 10, 2010

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 18, 2010

Completed
Last Updated

May 18, 2010

Status Verified

May 1, 2010

Enrollment Period

9 months

First QC Date

May 10, 2010

Last Update Submit

May 17, 2010

Conditions

Rectal Cancer

Outcome Measures

Primary Outcomes (1)

  • The difference in 1 month between two surgical methods in terms of Bladder function.

    The robotic surgery for rectal cancer seemed to be associated with a much earlier recovery of normal voiding and sexual function compared to those of laparoscopic surgery although it needs to be verified by larger prospective comparative studies

    1 month

Secondary Outcomes (2)

  • The difference in 3 months between two surgical methods in tems of Sexual function.

    3 months

  • The serial change of Bladder and sexual function according to times, in each operation method.

Study Arms (2)

robotic surgery group

Procedure: surgery(robot versus laparoscopy)

laparoscopic surgery group

Procedure: surgery(robot versus laparoscopy)

Interventions

surgery(robot versus laparoscopy)PROCEDURE
laparoscopic surgery grouprobotic surgery group

Eligibility Criteria

Age45 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The patients who visit Severance Hospital for rectal cancer

You may qualify if:

  • \> age \> 20
  • Rectal cancer
  • Non-distance metastasis
  • Agree with this study

You may not qualify if:

  • Benign prostate hyperplasia
  • Previous history of urinary bladder or prostate gland operation
  • Severe erectile dysfunction
  • Defined as patients whose erectile scores were less than 10 in a preoperative questionnaire of the International Index of Erectile Function (IIEF)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Nam Kyu Kim

    Department of Surgery, Yonsei University College of Medicine, Seoul, Korea

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

May 10, 2010

First Posted

May 18, 2010

Study Start

June 1, 2009

Primary Completion

March 1, 2010

Study Completion

March 1, 2010

Last Updated

May 18, 2010

Record last verified: 2010-05