Damage Control Laparotomy

Study Overview
=================
Brief Summary
-----------------
Randomized study to compare outcomes of patients undergoing damage control laparotomies versus definitive closure for which there is surgeon equipoise to randomize.

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.

Official Title
-----------------
Damage Control Laparotomy: A Randomized Controlled Trial

Conditions
-----------------
Other Injury of Other Intra-abdominal Organs, Initial Encounter

Intervention / Treatment
-----------------
* Procedure: Definitive Closure Laparotomy
* Procedure: Damage Control Laparotomy


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 16 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Definitive closure laparotomy<br>Subjects randomized to the definitive closure laparotomy arm will have the incision closed at the end of the exploratory laparotomy. | Procedure: Definitive Closure Laparotomy<br>* Subjects randomized to the definitive closure laparotomy arm will have the incision closed at the end of the exploratory laparotomy.<br>|
| Other: Damage control laparotomy<br>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. | Procedure: Damage Control Laparotomy<br>* 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.<br>|

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) | 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 | Non-abdominal Morbidities include Acute Kidney Failure, Deep Vein Thrombosis, Pulmonary Embolism, Pneumonia, and Urinary Tract Infection. | 30 days | 
| Number of Hospital-free Days | Number of days patient was not in hospital within the 30 day time frame. | 30 days | 
| Number of ICU-free Days | Number of days patient not in the ICU during the 30 day time frame | 30 days | 
| Number of Ventilator-free Days | Number of days patient not on ventilator in the 30 day time frame | 30 days | 
| Hospital Costs |  | 30 days | 
| Patient-centered Outcomes Assessed Using the Standard Gamble | 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 | 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) | 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) | 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) | 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) | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Exploratory Lap (Ex Lap), Damage Control Laparotomy (DCL), Definitive