Trial Comparing Early Laparoscopic Enterolysis Versus Nonoperative Management for High-grade SBO
Launched by YALE UNIVERSITY · Feb 22, 2016
Trial Information
Current as of May 21, 2025
Terminated
Keywords
ClinConnect Summary
Small bowel obstruction is a common disorder without a clearly superior management strategy. There are an estimated 300,000 surgeries performed annually with a health care expenditure burden in excess of 2.8 billion dollars. The investigators propose a new management paradigm including early laparoscopic management.
Contemporary management of SBO includes a trial of nonoperative management (TNOM) reportedly with resolution in upwards of 70% of patients.
Although it is one of the most common diagnosis for surgical admissions, there are few prospective, clinical trials to address the questi...
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • CT A/P showing high grade obstruction (all patients will obtain a CT A/P as per Level 1 recommendations based on EAST practice guidelines) .
- * High grade bowel obstruction is defined as:
- • Transition point
- • Distal small collapse with proximal dilatation
- • Small bowel feces sign
- • 50% difference in caliber change between proximal dilated bowel and distal decompressed bowel
- • Intra-abdominal free fluid without clinical signs of ischemia
- Exclusion Criteria:
- • Hemodynamic instability (SBP\<90)
- • Peritonitis
- • Enterocutaneous fistula
- • Cirrhosis
- • previous enterolysis (more than 1)
- • Contraindication to laparoscopic surgery
- • Pregnancy
About Yale University
Yale University, a prestigious Ivy League institution located in New Haven, Connecticut, is renowned for its commitment to advancing medical research and clinical innovation. With a rich history of academic excellence and a robust infrastructure for scientific inquiry, Yale serves as a leading sponsor for clinical trials aimed at improving patient care and developing new therapeutic approaches. The university's multidisciplinary teams of researchers and clinicians collaborate to conduct rigorous and ethical studies, leveraging cutting-edge technologies and methodologies to address critical health challenges. Through its dedication to fostering an environment of inquiry and discovery, Yale University plays a pivotal role in translating research findings into clinical practice, ultimately enhancing health outcomes for diverse populations.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
New Haven, Connecticut, United States
Patients applied
Trial Officials
Kevin Pei, MD
Principal Investigator
Yale University
Kimberly Davis, MD
Principal Investigator
Yale University
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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