Comparison of Limb Size of Transverse Coloplasty Pouch

August 14, 2019 updated by: Christoph A. Maurer, MD, Kantonsspital Liestal

Prospective Randomised Study for Comparison of the Size of Limb of Transverse Coloplasty Pouch After Low Rectal Resection With Total Mesorectal Excision

The aim of the study is the comparison of pouch function with two different sizes of limb of transverse coloplasty pouch after rectal resection and total mesorectal excision.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

No detailed description necessary, see brief summary.

Study Type

Interventional

Enrollment (Anticipated)

52

Phase

  • Not Applicable

Contacts and Locations

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

Study Contact

Study Locations

  • Switzerland
    • BL
      • Liestal, BL, Switzerland, 4410
        • Recruiting
        • KS Liestal
        • Contact:
        • Principal Investigator:
          • Christoph A. Maurer, Prof MD

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • all patients in need of rectal resection due to benign or malign disease
  • >=18 years

Exclusion Criteria:

  • anamnestic rectal resection
  • life expectancy of less than 2 years
  • pregnancy
  • <18 years
  • missing informed consent

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Transverse coloplasty pouch (Short limb)
The short limb is the standard technique of transverse coloplasty pouch.
Procedure: Transverse coloplasty pouch (Short limb)
Transverse coloplasty pouch with short limb
Experimental: Transverse coloplasty pouch (Long limb)
The long limb relates to straight coloanal anastomosis.
Procedure: Transverse coloplasty pouch (Long limb)
Transverse coloplasty pouch with long limb

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pouch function 4 month after closure of protective ileostomy.
Time Frame: 4 month
4 month

Secondary Outcome Measures

Outcome Measure
Time Frame
Pouch function 2 and 12 month respectively after closure of protective ileostomy.
Time Frame: 1 year
1 year

Collaborators and Investigators

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

Sponsor

Kantonsspital Liestal

Investigators

  • Principal Investigator: Christoph A Maurer, Prof, Kantonsspital Liestal

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

June 1, 2009

Primary Completion (Anticipated)

December 1, 2022

Study Completion (Anticipated)

December 1, 2023

Study Registration Dates

First Submitted

February 18, 2010

First Submitted That Met QC Criteria

February 18, 2010

First Posted (Estimate)

February 19, 2010

Study Record Updates

Last Update Posted (Actual)

August 15, 2019

Last Update Submitted That Met QC Criteria

August 14, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 303/08

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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