search
Back to results

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

Primary Purpose

Small Bowel Obstruction

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Early laparoscopic enterolysis
nonoperative management
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Small Bowel Obstruction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Yale New Haven Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Early laparoscopic enterolysis

trial of nonoperative management

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Average Length of stay
length, in days, of hospital stay, calculated by subtracting date of randomization from date of discharge
Average cost in dollars
average cost of care of patients per arm for length of hospital stay
number of subjects with hospital readmission
number of subjects with unplanned return to operating room
number of subjects with 30 day mortality

Full Information

First Posted
February 15, 2016
Last Updated
February 27, 2020
Sponsor
Yale University
search

1. Study Identification

Unique Protocol Identification Number
NCT02692638
Brief Title
Trial Comparing Early Laparoscopic Enterolysis Versus Nonoperative Management for High-grade SBO
Official Title
Prospective, Randomized Trial Comparing Early Laparoscopic Enterolysis Versus a Time-limited Trial of Nonoperative Management for High-grade Small Bowel Obstruction
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Terminated
Why Stopped
Low enrollment; PI left institution
Study Start Date
February 2, 2016 (Actual)
Primary Completion Date
October 13, 2016 (Actual)
Study Completion Date
October 13, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Small Bowel Obstruction

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Early laparoscopic enterolysis
Arm Type
Experimental
Arm Description
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.
Arm Title
trial of nonoperative management
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Early laparoscopic enterolysis
Intervention Description
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
Intervention Name(s)
nonoperative management
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of complications (per National Surgical Quality Improvement Project)
Description
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)
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Average Length of stay
Description
length, in days, of hospital stay, calculated by subtracting date of randomization from date of discharge
Time Frame
length of hospital stay, Time 0 is at randomization with expected length of stay less than 3 weeks.
Title
Average cost in dollars
Description
average cost of care of patients per arm for length of hospital stay
Time Frame
length of hospital stay, Time 0 is at randomization with expected length of stay less than 3 weeks.
Title
number of subjects with hospital readmission
Time Frame
within 2 weeks of discharge
Title
number of subjects with unplanned return to operating room
Time Frame
within two weeks of discharge
Title
number of subjects with 30 day mortality
Time Frame
30 days post operation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kevin Pei, MD
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kimberly Davis, MD
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale New Haven Hospital
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs