Comparison of Limb Size of Transverse Coloplasty Pouch | NCT01071824

Studies
Comparison of Limb Size of Transverse Coloplasty Pouch

NCT01071824

Sponsor

Kantonsspital Liestal

Status

Unknown status

Last Update Posted

Aug 15, 2019Actual

Enrollment

52Estimated

Phase

Not Applicable

Conditions

Colon Cancer

Interventions

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

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2009

Primary Completion Date

Dec 2022Estimated

Completion Date

Dec 2023Estimated

First Submitted Date

Feb 18, 2010

First Submission Date that Met QC Criteria

Feb 18, 2010

First Posted Date

Feb 19, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 14, 2019

Last Update Posted Date

Aug 15, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Christoph A. Maurer, MD, Prof. Dr. med. Christoph A. Maurer, Kantonsspital LiestalPrincipal Investigator

Lead Sponsor

Kantonsspital LiestalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

52Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Transverse coloplasty pouch (Long limb)	Procedure	Transverse coloplasty pouch with long limb	Transverse coloplasty pouch (Long limb)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pouch function 4 month after closure of protective ileostomy.		4 month

Secondary Outcomes

Measure	Description	Time Frame
Pouch function 2 and 12 month respectively after closure of protective ileostomy.		1 year

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Christoph A. Maurer, Prof.	Contact	+41619252150		christoph.maurer@ksli.ch

Overall Officials

Name	Affiliation	Role
Christoph A Maurer, Prof	Kantonsspital Liestal	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
KS Liestal	Recruiting	Liestal	Basel-Landschaft	4410	Switzerland

Condition Browse Module

MeSH Terms

ID	Term
D003110	Colonic Neoplasms

Ancestor Terms

ID	Term
D015179	Colorectal Neoplasms
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided