NCT01071824

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2009

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

February 18, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 19, 2010

Completed
12.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

August 15, 2019

Status Verified

August 1, 2019

Enrollment Period

13.5 years

First QC Date

February 18, 2010

Last Update Submit

August 14, 2019

Conditions

Colon Cancer

Keywords

sizelimbtransverse coloplasty pouchrectal resectionmesorectal excisiontreatment outcome

Outcome Measures

Primary Outcomes (1)

  • Pouch function 4 month after closure of protective ileostomy.

    4 month

Secondary Outcomes (1)

  • Pouch function 2 and 12 month respectively after closure of protective ileostomy.

    1 year

Study Arms (2)

Transverse coloplasty pouch (Short limb)

ACTIVE COMPARATOR

The short limb is the standard technique of transverse coloplasty pouch.

Procedure: Transverse coloplasty pouch (Short limb)

Transverse coloplasty pouch (Long limb)

EXPERIMENTAL

The long limb relates to straight coloanal anastomosis.

Procedure: Transverse coloplasty pouch (Long limb)

Interventions

Transverse coloplasty pouch (Long limb)PROCEDURE

Transverse coloplasty pouch with long limb

Transverse coloplasty pouch (Long limb)
Transverse coloplasty pouch (Short limb)PROCEDURE

Transverse coloplasty pouch with short limb

Transverse coloplasty pouch (Short limb)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • all patients in need of rectal resection due to benign or malign disease
  • \>=18 years

You may not qualify if:

  • anamnestic rectal resection
  • life expectancy of less than 2 years
  • pregnancy
  • \<18 years
  • missing informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

KS Liestal

Liestal, Basel-Landschaft, 4410, Switzerland

RECRUITING

MeSH Terms

Conditions

Colonic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal Diseases

Study Officials

  • Christoph A Maurer, Prof

    Kantonsspital Liestal

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Christoph A. Maurer, Prof.

CONTACT

+41619252150christoph.maurer@ksli.ch

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. med. Christoph A. Maurer

Study Record Dates

First Submitted

February 18, 2010

First Posted

February 19, 2010

Study Start

June 1, 2009

Primary Completion

December 1, 2022

Study Completion

December 1, 2023

Last Updated

August 15, 2019

Record last verified: 2019-08

Locations

CH(1)