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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
Kantonsspital Liestal
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
February 18, 2010
Last Updated
August 14, 2019
Sponsor
Kantonsspital Liestal
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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

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Comparison of Limb Size of Transverse Coloplasty Pouch

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