Observational Analysis of the Cause of Leaks When Bowel is Cut and Reconnected
Prospective Assessment of Anastomotic Leak
1 other identifier
observational
1,077
1 country
1
Brief Summary
The purpose of this study is to identify the cause of leaks that sometimes occur after a section of the bowel is removed and reconnected. Certain staplers from the operating room will be collected and sent to a third party (ECRI Institute) to be examined for defects. The patient's charts will be analyzed for medical issues that may contribute to leaks after surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2013
Longer than P75 for all trials
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
October 1, 2013
CompletedFirst Submitted
Initial submission to the registry
June 26, 2014
CompletedFirst Posted
Study publicly available on registry
June 30, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2018
CompletedFebruary 5, 2018
February 1, 2018
4.3 years
June 26, 2014
February 2, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
All cause bowel leaks after surgery
one week post-operation
All cause bowel leaks after surgery
one month post-operation
Secondary Outcomes (4)
Reoperation
1 year post operation
Sepsis
1 year post operation
Length of hospital stay
1 year post operation
Mortality
1 year post operation
Study Arms (2)
Subjects over age 18
Subjects undergoing non-emergent small bowel or large bowel surgery and reconnection of bowel that are over the age of 18
Subjects age 15-17
Subjects undergoing non-emergent small bowel or large bowel surgery and reconnection of bowel that are age 15-17 with one permission of one parent.
Eligibility Criteria
Patients who are scheduled to have a small or large bowel surgery and reconnection of bowel will be selected from the operating room schedule at Icahn School of Medicine at Mount Sinai.
You may qualify if:
- Subject must be scheduled for non-emergent small or large bowel surgery and reconnection of bowel at Icahn School of Medicine at Mount Sinai
- Subjects must be able and willing to provide informed consent
- Subjects must be 18 years or above OR 15-17 with permission of one parent
- English and Spanish speaking patients will be included in this study
You may not qualify if:
- Subject who are less than 15 years of age
- Subject who are scheduled for emergent surgery, precluding the capacity to give informed consent
- Subjects who are diagnosed with obstructed or perforated colon cancer
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Icahn School of Medicine at Mount Sinailead
- ECRI Institutecollaborator
- Medtronic - MITGcollaborator
Study Sites (1)
Icahn School of Medicine at Mount Sinai
New York, New York, 10029, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Celia Divino, M.D. FACS
Icahn School of Medicine at Mount Sinai
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 26, 2014
First Posted
June 30, 2014
Study Start
October 1, 2013
Primary Completion
January 31, 2018
Study Completion
January 31, 2018
Last Updated
February 5, 2018
Record last verified: 2018-02