Quality of Life in Patients That Undergo J Pouch or Side... | NCT01182116

Studies
Quality of Life in Patients That Undergo J Pouch or Side to End Coloanal Anastomosis for Rectal Cancer

NCT01182116

Sponsor

The Cleveland Clinic

Status

Completed

Last Update Posted

May 9, 2018Actual

Enrollment

46Actual

Phase

Not Applicable

Conditions

Rectal Cancer

Interventions

J Pouch

Countries

United States

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

May 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2009

Primary Completion Date

Dec 2016Actual

Completion Date

Dec 2016Actual

First Submitted Date

May 25, 2010

First Submission Date that Met QC Criteria

Aug 13, 2010

First Posted Date

Aug 16, 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

May 8, 2018

Last Update Posted Date

May 9, 2018Actual

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 investigators hypothesis is that the patients who receive a side to end anastomosis have bowel outcome and quality of life that is equivalent to those who receive a J pouch.

Detailed Description

The side to end anastomosis has become popular in recent years as it is technically simple to construct. The difference between the Baker type(side to end) of anastomosis and the J pouch, is that no formal pouch is constructed in the side to end. It has one staple line and the anastomosis.

The investigators hypothesis is that the patients who receive a side to end anastomosis have bowel outcome and quality of life that is equivalent to those who receive a J pouch.

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

46Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
J Pouch side to end	Experimental	Colorectal surgery Function Quality of Life	Procedure: J Pouch

Interventions

Name	Type	Description	Arm Group Labels	Other Names
J Pouch	Procedure	Comparing J pouch, side to end coloanal surgery	J Pouch side to end

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Improved function and capacity of the neorectum.		2 years from date of surgery

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with distal rectal cancers who will be having an abdominal proctocolectomy with a low colorectal anastomosis within 4 cm of the dentate line or a coloanal anastomosis will be candidates for this study.
No evidence of distant metastatsis -

Exclusion Criteria: Stage IV rectal cancer

History of radiation to the pelvis ( eg. for uterine or prostatic cancer)
Evidence of synchronus or metachronus disease
H/o dementia
Prisoners
Women who are pregnant
History of previous Right Colectomy
History of inflammatory bowel disease -

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Massarat Zutshi, MD	The Cleveland Clinic	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cleveland Clinic		Cleveland	Ohio	44195	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
30921049	Derived	Parc Y, Ruppert R, Fuerst A, Golcher H, Zutshi M, Hull T, Tiret E, Hemminger F, Galandiuk S, Fender S, Weber K, Zimmerman A, Aiello A, Fazio V. Better Function With a Colonic J-Pouch or a Side-to-end Anastomosis?: A Randomized Controlled Trial to Compare the Complications, Functional Outcome, and Quality of Life in Patients With Low Rectal Cancer After a J-Pouch or a Side-to-end Anastomosis. Ann Surg. 2019 May;269(5):815-826. doi: 10.1097/SLA.0000000000003249.

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

ID	Term
D019738	Surgically-Created Structures
D004864	Equipment and Supplies