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

Primary Purpose

Rectal Cancer

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

J Pouch

About this trial

This is an interventional treatment trial for Rectal Cancer focused on measuring J pouch, colorectal, rectal cancer, coloplasty

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 -

Sites / Locations

Cleveland Clinic

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

J Pouch side to end

Arm Description

Colorectal surgery Function Quality of Life

Outcomes

Primary Outcome Measures

Improved function and capacity of the neorectum.

Secondary Outcome Measures

Full Information

NCT ID

NCT01182116

First Posted

May 25, 2010

Last Updated

May 8, 2018

Sponsor

The Cleveland Clinic

1. Study Identification

Unique Protocol Identification Number

NCT01182116

Brief Title

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

Official Title

A Randomized, Controlled Trial to Compare the Functional Outcome and Quality of Life in Patients With Low Rectal Cancer Who Undergo a J Pouch or a Side to End Coloanal Anastomosis

Study Type

Interventional

2. Study Status

Record Verification Date

May 2018

Overall Recruitment Status

Completed

Study Start Date

March 2009 (undefined)

Primary Completion Date

December 2016 (Actual)

Study Completion Date

December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

The Cleveland Clinic

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rectal Cancer

Keywords

J pouch, colorectal, rectal cancer, coloplasty

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

46 (Actual)

8. Arms, Groups, and Interventions

Arm Title

J Pouch side to end

Arm Type

Experimental

Arm Description

Colorectal surgery Function Quality of Life

Intervention Type

Procedure

Intervention Name(s)

J Pouch

Intervention Description

Comparing J pouch, side to end coloanal surgery

Primary Outcome Measure Information:

Title

Improved function and capacity of the neorectum.

Time Frame

2 years from date of surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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 -

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Massarat Zutshi, MD

Organizational Affiliation

The Cleveland Clinic

Official's Role

Principal Investigator

Facility Information:

Facility Name

Cleveland Clinic

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44195

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

30921049

Citation

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.

Results Reference

derived

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

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