Comparison of Limb Size of Transverse Coloplasty Pouch

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2014 by Kantonsspital Liestal.
Recruitment status was  Recruiting
Information provided by (Responsible Party):
Christoph A. Maurer, MD, Kantonsspital Liestal Identifier:
First received: February 18, 2010
Last updated: February 5, 2014
Last verified: February 2014
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 Intervention
Colon Cancer
Procedure: Transverse coloplasty pouch (Long limb)
Procedure: Transverse coloplasty pouch (Short limb)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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

Further study details as provided by Kantonsspital Liestal:

Primary Outcome Measures:
  • Pouch function 4 month after closure of protective ileostomy. [ Time Frame: 4 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pouch function 2 and 12 month respectively after closure of protective ileostomy. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 52
Study Start Date: June 2009
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01071824

Contact: Christoph A. Maurer, Prof. +41619252150

KS Liestal Recruiting
Liestal, BL, Switzerland, 4410
Contact: Christoph A. Maurer, Prof.    +41619252150   
Principal Investigator: Christoph A. Maurer, Prof MD         
Sponsors and Collaborators
Kantonsspital Liestal
Principal Investigator: Christoph A Maurer, Prof Kantonsspital Liestal
  More Information

Responsible Party: Christoph A. Maurer, MD, Prof. Dr. med. Christoph A. Maurer, Kantonsspital Liestal Identifier: NCT01071824     History of Changes
Other Study ID Numbers: 303/08 
Study First Received: February 18, 2010
Last Updated: February 5, 2014
Health Authority: Switzerland: Ethikkommission

Keywords provided by Kantonsspital Liestal:
transverse coloplasty pouch
rectal resection
mesorectal excision
treatment outcome processed this record on May 23, 2016