Comparison of Limb Size of Transverse Coloplasty Pouch

This study is currently recruiting participants.
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

February 18, 2010
February 5, 2014
June 2009
December 2014   (final data collection date for primary outcome measure)
Pouch function 4 month after closure of protective ileostomy. [ Time Frame: 4 month ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01071824 on ClinicalTrials.gov Archive Site
Pouch function 2 and 12 month respectively after closure of protective ileostomy. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Comparison of Limb Size of Transverse Coloplasty Pouch
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.

No detailed description necessary, see brief summary.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Colon Cancer
  • Procedure: Transverse coloplasty pouch (Long limb)
    Transverse coloplasty pouch with long limb
  • Procedure: Transverse coloplasty pouch (Short limb)
    Transverse coloplasty pouch with short limb
  • Active Comparator: Transverse coloplasty pouch (Short limb)
    The short limb is the standard technique of transverse coloplasty pouch.
    Intervention: Procedure: Transverse coloplasty pouch (Short limb)
  • Experimental: Transverse coloplasty pouch (Long limb)
    The long limb relates to straight coloanal anastomosis.
    Intervention: Procedure: Transverse coloplasty pouch (Long limb)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
52
December 2015
December 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Christoph A. Maurer, Prof. +41619252150 christoph.maurer@ksli.ch
Switzerland
 
NCT01071824
303/08
Yes
Christoph A. Maurer, MD, Kantonsspital Liestal
Kantonsspital Liestal
Not Provided
Principal Investigator: Christoph A Maurer, Prof Kantonsspital Liestal
Kantonsspital Liestal
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP