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

NCT ID: NCT02692638

Last Updated: 2020-03-02

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-02
• Study Completion Date: 2016-10-13

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.

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.

Conditions

Small Bowel Obstruction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Early laparoscopic enterolysis

Intervention Type: 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.

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.

Group Type: ACTIVE_COMPARATOR

nonoperative management

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kevin Pei, MD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Kimberly Davis, MD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

Yale New Haven Hospital

New Haven, Connecticut, United States

Countries

United States

Other Identifiers

1512016944

Identifier Type: -

Identifier Source: org_study_id