Damage Control Laparotomy

October 19, 2021 updated by: John Andrew Harvin, The University of Texas Health Science Center, Houston

Damage Control Laparotomy: A Randomized Controlled Trial

Randomized study to compare outcomes of patients undergoing damage control laparotomies versus definitive closure for which there is surgeon equipoise to randomize.

Study Overview

Detailed Description

Single center, prospective, randomized study involving seriously injure patients requiring an emergent laparotomy within 90 minutes of arrival to the emergency department. There are situations in which the patient is unable to be closed at the end of the emergent laparotomy (identified as damage control) and there are situations in which the injury has been treated and the incision can be closed (definitive). There are also situations where it is not clear if the patient should be kept open or closed and the result of the surgery varies based on the surgeon performing the case.

The eligible subjects for this study will be randomized toward the end of the emergent laparotomy procedure on a 1:1 basis and will be followed throughout the hospitalization for complications. Patients will also be contacted at 6 month to complete a quality of life questionnaire.

Study Type

Interventional

Enrollment (Actual)

39

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Texas
      • Houston, Texas, United States, 77030
        • Memorial Hermann Hospital - Texas Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Emergent laparotomy
  • Patient has injuries for which surgeon has equipoise to perform a Definitive (DEF) or Damage Control Laparotomy (DCL)
  • Age ≥16 years (age cut-off for admission to adult trauma service at Memorial Hermann Hospital-Texas Medical Center)

Exclusion Criteria:

  • Indication for DCL for which there is no surgeon equipoise:

    • Need for gauze packing of liver or retroperitoneum for hemorrhage control
    • Immediate need to go to Interventional Radiology for hemorrhage control
    • Concern for Abdominal Compartment Syndrome - defined as physically unable to re-approximate fascia or >10mmHg change in peak airway pressure during fascial closure
    • Hemodynamic instability - defined as persistent hypotension, ongoing transfusion requirement, or continuous vasopressor use
  • Indication for DEF for which there is no surgeon equipoise:

    • Negative and non-therapeutic laparotomies
    • Isolated cystorrhaphy
  • Prisoners
  • Known pregnancy
  • Patients with burns > 20% of total body surface area
  • Patient/legally authorized representative opted out of exception from informed consent (opt out bracelet)
  • Currently enrolled in another interventional study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Definitive closure laparotomy
Subjects randomized to the definitive closure laparotomy arm will have the incision closed at the end of the exploratory laparotomy.
Subjects randomized to the definitive closure laparotomy arm will have the incision closed at the end of the exploratory laparotomy.
Other: Damage control laparotomy
Subjects randomized to the damage control laparotomy arm will have the incision left open at the end of the exploratory laparotomy. The trauma team will evaluate the patient's clinical course to determine when the incision can be closed.
Subjects randomized to the damage control laparotomy arm will have the incision left open at the end of the exploratory laparotomy. The trauma team will evaluate the patient's clinical course to determine when the incision can be closed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Who Died or Had Major Abdominal Complication (MAC)
Time Frame: 30 days
Major abdominal complication (MAC) is defined as development of an organ/space surgical site infection, enteric suture line failure, fascial dehiscence, or unplanned return to operating room (OR).
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Non-abdominal Morbidities
Time Frame: 30 days
Non-abdominal Morbidities include Acute Kidney Failure, Deep Vein Thrombosis, Pulmonary Embolism, Pneumonia, and Urinary Tract Infection.
30 days
Number of Hospital-free Days
Time Frame: 30 days
Number of days patient was not in hospital within the 30 day time frame.
30 days
Number of ICU-free Days
Time Frame: 30 days
Number of days patient not in the ICU during the 30 day time frame
30 days
Number of Ventilator-free Days
Time Frame: 30 days
Number of days patient not on ventilator in the 30 day time frame
30 days
Hospital Costs
Time Frame: 30 days
30 days
Patient-centered Outcomes Assessed Using the Standard Gamble
Time Frame: at discharge from hospital (about 20 days after intervention)
Participants are asked to choose between two hypothetical outcomes: 1 - the sure outcome, that is, remaining in a state of ill health for a period of time; or 2 - the gamble, that is, choosing a medical intervention which has a certain probability of either restoring them to perfect health or killing them. The Standard Gamble identifies the probability (of the intervention delivering perfect health) at which the two alternatives (1 and 2) seem equally attractive. Scores range from 0% to 100%, with a score of 100% indicating that a choices 1 and 2 are equally attractive only when there is a 100% probability that the intervention will deliver perfect health, and a score of 0% indicating that choices 1 and and 2 are equally attractive even when there is a 0% probability that the intervention will deliver perfect health.
at discharge from hospital (about 20 days after intervention)
Patient-centered Outcomes Assessed Using the Standard Gamble
Time Frame: 6 months after discharge from hospital
Participants are asked to choose between two hypothetical outcomes: 1 - the sure outcome, that is, remaining in a state of ill health for a period of time; or 2 - the gamble, that is, choosing a medical intervention which has a certain probability of either restoring them to perfect health or killing them. The Standard Gamble identifies the probability (of the intervention delivering perfect health) at which the two alternatives (1 and 2) seem equally attractive. Scores range from 0% to 100%, with a score of 100% indicating that a choices 1 and 2 are equally attractive only when there is a 100% probability that the intervention will deliver perfect health, and a score of 0% indicating that choices 1 and and 2 are equally attractive even when there is a 0% probability that the intervention will deliver perfect health.
6 months after discharge from hospital
Patient-centered Outcomes Assessed Using the 5-level European Quality of Life Scale-5D (EuroQol-5D-5L)
Time Frame: at discharge from hospital (about 20 days after intervention)
The EuroQol-5D-5L assesses health-related quality of life. Total score ranges from 0 to 100, with 0 indicating the worst health imaginable and 100 indicating the best health imaginable.
at discharge from hospital (about 20 days after intervention)
Patient-centered Outcomes Assessed Using the 5-level European Quality of Life Scale-5D (EuroQol-5D-5L)
Time Frame: 6 months after discharge from hospital
The EuroQol-5D-5L assesses health-related quality of life. Total score ranges from 0 to 100, with 0 indicating the worst health imaginable and 100 indicating the best health imaginable.
6 months after discharge from hospital
Patient-centered Outcomes Assessed Using the Post-Traumatic Stress Disorder Check List - Civilian (PCL-C)
Time Frame: at discharge from hospital (about 20 days after intervention)
The PCL-C assesses Post-Traumatic Stress Disorder (PTSD) symptoms. Total score ranges from 17-85. A score of 17-29 shows little to no PTSD symptoms. A score of 28-29 indicates some PTSD symptoms. A score of 30-44 indicates moderate to moderately high severity of PTSD symptoms. A score of 45-85 indicates high severity of PTSD symptoms.
at discharge from hospital (about 20 days after intervention)
Patient-centered Outcomes Assessed Using the Post-Traumatic Stress Disorder Check List - Civilian (PCL-C)
Time Frame: 6 months after discharge from hospital
The PCL-C assesses Post-Traumatic Stress Disorder (PTSD) symptoms. Total score ranges from 17-85. A score of 17-29 shows little to no PTSD symptoms. A score of 28-29 indicates some PTSD symptoms. A score of 30-44 indicates moderate to moderately high severity of PTSD symptoms. A score of 45-85 indicates high severity of PTSD symptoms.
6 months after discharge from hospital

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: John Harvin, MD, The University of Texas Health Science Center, Houston

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2016

Primary Completion (Actual)

November 30, 2019

Study Completion (Actual)

April 30, 2020

Study Registration Dates

First Submitted

February 27, 2016

First Submitted That Met QC Criteria

March 10, 2016

First Posted (Estimate)

March 11, 2016

Study Record Updates

Last Update Posted (Actual)

November 18, 2021

Last Update Submitted That Met QC Criteria

October 19, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • HSC-GEN-16-0104
  • KL2TR000370 (U.S. NIH Grant/Contract)
  • UL1TR000371 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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