Comparison of Limb Size of Transverse Coloplasty Pouch

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Kantonsspital Liestal
Sponsor:
Information provided by (Responsible Party):
Christoph A. Maurer, MD, Kantonsspital Liestal
ClinicalTrials.gov Identifier:
NCT01071824
First received: February 18, 2010
Last updated: February 5, 2014
Last verified: February 2014
  Purpose

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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 ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: February 18, 2010
Last Updated: February 5, 2014
Health Authority: Switzerland: Ethikkommission

Keywords provided by Kantonsspital Liestal:
size
limb
transverse coloplasty pouch
rectal resection
mesorectal excision
treatment outcome

ClinicalTrials.gov processed this record on October 16, 2014