Clinical trial NCT02178228: Observational Analysis of the Cause of Leaks When Bowel is Cut and Reconnected
Official title: Prospective Assessment of Anastomotic Leak
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anastomotic Leaks
Keywords: Anastomotic Leaks
Bowel Resection
Postoperative Complication
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
Collaborators: name: ECRI Institute
name: Medtronic - MITG
First posted: 2014-06-30
Enrollment: 1077
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

Detailed description: The objective of this study is to identify peri-operative factors that contribute to leaks after a portion of the bowel has been cut and reconnected. Most specifically, the role of staplers in this reconnection of the bowels will be evaluated. The research will take place at Icahn School of Medicine where there is an extremely high volume of operations involving small bowel and large bowel being cut and reconnected. Patients will be recruited based on inclusion and exclusion criteria and 500 subjects are expected to be enrolled in the study. The surgery will be performed in a standard fashion as indicated by diagnosis, location of disease, patient condition, and surgeon preference. No changes to the surgical procedure will be mandated by the research protocol. This is purely an observational study with no changes to the standard of care. The patients will be followed throughout the course of the their hospital stay for the scheduled surgery up to one week and one month after the procedure to gather laboratory data and any complications incurred due to the surgery. No patient specimen will be stored. The staplers used in the procedure will be collected, stored in sterile plastic container, information about the staplers will be recorded, and then discarded after 30 days in the usual manner that the operating room staff employs to discard the staplers. Subjects lost to follow-up after the procedure will be withdrawn from the study.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: All cause bowel leaks after surgery
timeFrame: one week post-operation
measure: All cause bowel leaks after surgery
timeFrame: one month post-operation
Secondary outcomes:
measure: Reoperation
timeFrame: 1 year post operation
measure: Sepsis
timeFrame: 1 year post operation
measure: Length of hospital stay
timeFrame: 1 year post operation
measure: Mortality
timeFrame: 1 year post operation
Other outcomes:
Locations:
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Celia Divino, M.D. FACS
role: PRINCIPAL_INVESTIGATOR
References: