Trial Comparing Early Laparoscopic Enterolysis Versus Nonoperative Management for High-grade SBO

Prospective, Randomized Trial Comparing Early Laparoscopic Enterolysis Versus a Time-limited Trial of Nonoperative Management for High-grade Small Bowel Obstruction

The goal is to assess the appropriateness of the standard practice of a trial of nonoperative management for high grade small bowel obstruction (currently up to 72 hours based on available literature). The investigator will offer early laparoscopic enterolysis (within 24 hours of admission) as the comparator group.

Study Overview

• Status: Terminated
• Conditions: Small Bowel Obstruction
• Intervention / Treatment: Procedure: Early laparoscopic enterolysis; Procedure: nonoperative management

Detailed Description

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 question surgical timing. Additionally, there are no prospective, randomized trials comparing early laparoscopy versus TNOM for high grade SBO. The hypothesis is that early laparoscopic enterolysis will result in decreased overall complications, shorter length of stay, decreased health care cost, and lower conversion rate to open laparotomy.

• Study Type: Interventional
• Enrollment (Actual): 3
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Yale New Haven Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Early laparoscopic enterolysis; Patient randomized to the early laparoscopy arm will undergo diagnostic laparoscopy within 24 hours of admission (depending on surgeon and operating room availability). Standard laparoscopy will be performed including supine positioning, sequential compression devices, and appropriate pre-incision antibiotics. Trocar placement will be at the surgeon's discretion and as appropriate for the patient's previous incisions. The necessity for conversion will be left to the discretion of the attending surgeon. Post operative management will conform to the standards of care. Nasogastric tubes will not be routinely placed.	Procedure: Early laparoscopic enterolysis; The surgeon will make about 3-4 small incisions in the participant's abdomen. A port (nozzle) is inserted into one of the slits, and carbon dioxide gas inflates the abdomen. A laparoscope is inserted through another port. The laparoscope looks like a telescope with a light and camera on the end so the surgeon can see inside the abdomen. Surgical instruments are placed in the other small openings and used to cut the scar tissue in order to relieve the obstruction. After all this has been accomplished, the carbon dioxide is released out of the abdomen through the slits, and then these sites are closed with sutures or staples, or covered with glue-like bandage and steri-strips.
Active Comparator: trial of nonoperative management; Patients randomized to the trial of nonoperative management arm will undergo standard therapy including nil per os (NPO), nasogastric decompression only if actively vomiting, intravenous fluids while awaiting return of bowel function. Patients who do not achieve return of bowel function within 72 hours of admission will undergo attempted laparoscopic enterolysis with the understanding that conversion to open procedure may be necessary.	Procedure: nonoperative management; Sometimes a bowel obstruction can be treated by suctioning out the contents of the stomach, giving IV fluids, and not letting the patient eat for a few days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of complications (per National Surgical Quality Improvement Project)	complications counted : Superficial surgical site infection (SSI), Deep SSI, Organ space SSI, Wound disruption, pneumonia, Pulmonary embolism, ventilator days, Acute Kidney Injury (AKI), Acute renal failure (ARF), Urinary Tract Infection (UTI), Stroke, Cardiac arrest, Myocardial Infarction (MI), Sepsis, Deep vein thrombosis (DVT)	2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average Length of stay	length, in days, of hospital stay, calculated by subtracting date of randomization from date of discharge	length of hospital stay, Time 0 is at randomization with expected length of stay less than 3 weeks.
Average cost in dollars	average cost of care of patients per arm for length of hospital stay	length of hospital stay, Time 0 is at randomization with expected length of stay less than 3 weeks.
number of subjects with hospital readmission		within 2 weeks of discharge
number of subjects with unplanned return to operating room		within two weeks of discharge
number of subjects with 30 day mortality		30 days post operation

Collaborators and Investigators

• Sponsor: Yale University
• Investigators: Principal Investigator: Kevin Pei, MD, Yale University; Principal Investigator: Kimberly Davis, MD, Yale University

Study record dates

Study Major Dates

• Study Start (Actual): February 2, 2016
• Primary Completion (Actual): October 13, 2016
• Study Completion (Actual): October 13, 2016

Study Registration Dates

• First Submitted: February 15, 2016
• First Submitted That Met QC Criteria: February 22, 2016
• First Posted (Estimate): February 26, 2016

Study Record Updates

• Last Update Posted (Actual): March 2, 2020
• Last Update Submitted That Met QC Criteria: February 27, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Obstruction
• Other Study ID Numbers: 1512016944

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO