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Comparison of Limb Size of Transverse Coloplasty Pouch

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ClinicalTrials.gov Identifier: NCT01071824
Recruitment Status : Recruiting
First Posted : February 19, 2010
Last Update Posted : August 31, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment
Colon Cancer Procedure: Transverse coloplasty pouch (Long limb) Procedure: Transverse coloplasty pouch (Short limb)

Detailed Description:
No detailed description necessary, see brief summary.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Prospective Randomised Study for Comparison of the Size of Limb of Transverse Coloplasty Pouch After Low Rectal Resection With Total Mesorectal Excision
Study Start Date : June 2009
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2019
Arms and Interventions

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


Outcome Measures

Primary Outcome Measures :
  1. Pouch function 4 month after closure of protective ileostomy. [ Time Frame: 4 month ]

Secondary Outcome Measures :
  1. Pouch function 2 and 12 month respectively after closure of protective ileostomy. [ Time Frame: 1 year ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01071824


Contacts
Contact: Christoph A. Maurer, Prof. +41619252150 christoph.maurer@ksli.ch

Locations
Switzerland
KS Liestal Recruiting
Liestal, BL, Switzerland, 4410
Contact: Christoph A. Maurer, Prof.    +41619252150    christoph.maurer@ksli.ch   
Principal Investigator: Christoph A. Maurer, Prof MD         
Sponsors and Collaborators
Kantonsspital Liestal
Investigators
Principal Investigator: Christoph A Maurer, Prof Kantonsspital Liestal
More Information

Responsible Party: Christoph A. Maurer, MD, Prof. Dr. med. Christoph A. Maurer, Kantonsspital Liestal
ClinicalTrials.gov Identifier: NCT01071824     History of Changes
Other Study ID Numbers: 303/08
First Posted: February 19, 2010    Key Record Dates
Last Update Posted: August 31, 2017
Last Verified: August 2017

Keywords provided by Christoph A. Maurer, MD, Kantonsspital Liestal:
size
limb
transverse coloplasty pouch
rectal resection
mesorectal excision
treatment outcome