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

NCT02692638 | Terminated Phase 2

• 1 other identifier: 1512016944
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Small Bowel Obstruction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Average Length of stay

  length of hospital stay, Time 0 is at randomization with expected length of stay less than 3 weeks.

• Average cost in dollars

  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

Study Arms (2)

Early laparoscopic enterolysis

EXPERIMENTAL

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

trial of nonoperative management

ACTIVE COMPARATOR

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

Interventions

Early laparoscopic enterolysis PROCEDURE

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.

Early laparoscopic enterolysis

nonoperative management PROCEDURE

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.

trial of nonoperative management

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• % difference in caliber change between proximal dilated bowel and distal decompressed bowel
• Intra-abdominal free fluid without clinical signs of ischemia

You may not qualify if:

• Hemodynamic instability (SBP\<90)
• Peritonitis
• Enterocutaneous fistula
• Cirrhosis
• previous enterolysis (more than 1)
• Contraindication to laparoscopic surgery
• Pregnancy

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

Yale New Haven Hospital

New Haven, Connecticut, 06510, United States

Location

Study Officials

• Kevin Pei, MD

  Yale University

  PRINCIPAL INVESTIGATOR

• Kimberly Davis, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2016
• First Posted: February 26, 2016
• Study Start: February 2, 2016
• Primary Completion: October 13, 2016
• Study Completion: October 13, 2016
• Last Updated: March 2, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)