Quality of Life in Patients That Undergo J Pouch or Side to End Coloanal Anastomosis for Rectal Cancer
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
1 other identifier
interventional
46
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2009
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2009
CompletedFirst Submitted
Initial submission to the registry
May 25, 2010
CompletedFirst Posted
Study publicly available on registry
August 16, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedMay 9, 2018
May 1, 2018
7.8 years
May 25, 2010
May 8, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Improved function and capacity of the neorectum.
2 years from date of surgery
Study Arms (1)
J Pouch side to end
EXPERIMENTALColorectal surgery Function Quality of Life
Interventions
Eligibility Criteria
You may qualify if:
- 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 -
You may not qualify if:
- 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 -
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cleveland Clinic
Cleveland, Ohio, 44195, United States
Related Publications (1)
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.
PMID: 30921049DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Massarat Zutshi, MD
The Cleveland Clinic
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
May 25, 2010
First Posted
August 16, 2010
Study Start
March 1, 2009
Primary Completion
December 1, 2016
Study Completion
December 1, 2016
Last Updated
May 9, 2018
Record last verified: 2018-05
Data Sharing
- IPD Sharing
- Will not share