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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 2010 by Kantonsspital Liestal.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Kantonsspital Liestal
ClinicalTrials.gov Identifier:
NCT01071824
First received: February 18, 2010
Last updated: NA
Last verified: February 2010
History: No changes posted
  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
Rectal Resection
 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 2011
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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: Long limb
The long limb relates to straight coloanal anastomosis.
 Procedure: Transverse coloplasty pouch (Long limb)
Transverse coloplasty pouch with long limb

  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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01071824

Contacts
Contact: Daniela A. Mueller, MSc/ EMBA +41619252154 daniela.mueller@ksli.ch

Locations
Switzerland
KS Liestal Recruiting
Liestal, BL, Switzerland, 4410
Contact: Daniela A. Mueller, MSc/ EMBA     +41619252154     daniela.mueller@ksli.ch    
Principal Investigator: Christoph A. Maurer, Prof MD            
Sponsors and Collaborators
Kantonsspital Liestal
  More Information

No publications provided

Responsible Party: Maurer Christoph A. / Prof. MD, KS Liestal
ClinicalTrials.gov Identifier: NCT01071824     History of Changes
Other Study ID Numbers: 303/08
Study First Received: February 18, 2010
Last Updated: February 18, 2010
Health Authority: Switzerland: Ethics Committee

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

ClinicalTrials.gov processed this record on May 22, 2013