Comparison of Limb Size of Transverse Coloplasty Pouch
Primary Purpose
Colon Cancer
Status
Recruiting
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Transverse coloplasty pouch (Long limb)
Transverse coloplasty pouch (Short limb)
Sponsored by
About this trial
This is an interventional treatment trial for Colon Cancer focused on measuring size, limb, transverse coloplasty pouch, rectal resection, mesorectal excision, treatment outcome
Eligibility 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
Sites / Locations
- KS LiestalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Transverse coloplasty pouch (Short limb)
Transverse coloplasty pouch (Long limb)
Arm Description
The short limb is the standard technique of transverse coloplasty pouch.
The long limb relates to straight coloanal anastomosis.
Outcomes
Primary Outcome Measures
Pouch function 4 month after closure of protective ileostomy.
Secondary Outcome Measures
Pouch function 2 and 12 month respectively after closure of protective ileostomy.
Full Information
NCT ID
NCT01071824
First Posted
February 18, 2010
Last Updated
August 14, 2019
Sponsor
Kantonsspital Liestal
1. Study Identification
Unique Protocol Identification Number
NCT01071824
Brief Title
Comparison of Limb Size of Transverse Coloplasty Pouch
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 Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Recruiting
Study Start Date
June 2009 (undefined)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kantonsspital Liestal
4. Oversight
Data Monitoring Committee
Yes
5. 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.
Detailed Description
No detailed description necessary, see brief summary.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colon Cancer
Keywords
size, limb, transverse coloplasty pouch, rectal resection, mesorectal excision, treatment outcome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
52 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Transverse coloplasty pouch (Short limb)
Arm Type
Active Comparator
Arm Description
The short limb is the standard technique of transverse coloplasty pouch.
Arm Title
Transverse coloplasty pouch (Long limb)
Arm Type
Experimental
Arm Description
The long limb relates to straight coloanal anastomosis.
Intervention Type
Procedure
Intervention Name(s)
Transverse coloplasty pouch (Long limb)
Intervention Description
Transverse coloplasty pouch with long limb
Intervention Type
Procedure
Intervention Name(s)
Transverse coloplasty pouch (Short limb)
Intervention Description
Transverse coloplasty pouch with short limb
Primary Outcome Measure Information:
Title
Pouch function 4 month after closure of protective ileostomy.
Time Frame
4 month
Secondary Outcome Measure Information:
Title
Pouch function 2 and 12 month respectively after closure of protective ileostomy.
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christoph A. Maurer, Prof.
Phone
+41619252150
Email
christoph.maurer@ksli.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christoph A Maurer, Prof
Organizational Affiliation
Kantonsspital Liestal
Official's Role
Principal Investigator
Facility Information:
Facility Name
KS Liestal
City
Liestal
State/Province
BL
ZIP/Postal Code
4410
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christoph A. Maurer, Prof.
Phone
+41619252150
Email
christoph.maurer@ksli.ch
First Name & Middle Initial & Last Name & Degree
Christoph A. Maurer, Prof MD
12. IPD Sharing Statement
Learn more about this trial
Comparison of Limb Size of Transverse Coloplasty Pouch
We'll reach out to this number within 24 hrs