Memorial Hermann Hospital - Texas Medical Center
Houston, Texas, 77030, United States
Completed
NCT Number: NCT02706041
Damage Control Laparotomy
Randomized study to compare outcomes of patients undergoing damage control laparotomies versus definitive closure for which there is surgeon equipoise to randomize.
Completed
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Notify MeKey information
Age range
16 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Definitive Closure Laparotomy
ProcedureSubjects randomized to the definitive closure laparotomy arm will have the incision closed at the end of the exploratory laparotomy.
Damage Control Laparotomy
ProcedureSubjects 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.
Primary outcomes
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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).
Secondary outcomes
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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.
-
Number of Hospital-free Days
Time frame: 30 days
Number of days patient was not in hospital within the 30 day time frame.
-
Number of ICU-free Days
Time frame: 30 days
Number of days patient not in the ICU during the 30 day time frame
-
Number of Ventilator-free Days
Time frame: 30 days
Number of days patient not on ventilator in the 30 day time frame
-
Hospital Costs
Time frame: 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.
-
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.
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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.
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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.
-
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.
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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.
Sponsors and collaborators
Lead sponsor
The University of Texas Health Science Center, Houston
Other
Collaborators
- National Center for Advancing Translational Sciences (NCATS)
Registry information
Official study title
Damage Control Laparotomy: A Randomized Controlled Trial
Important dates
- Study start
- 2016
- Primary completion
- 2019
- Study completion
- 2020
- First posted
- Mar 11, 2016
- Registry last updated
- Nov 18, 2021
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.