- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02706041
Damage Control Laparotomy
Damage Control Laparotomy: A Randomized Controlled Trial
Study Overview
Status
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77030
- Memorial Hermann Hospital - Texas Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
Investigators
- Principal Investigator: John Harvin, MD, The University of Texas Health Science Center, Houston
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Other Injury of Other Intra-abdominal Organs, Initial Encounter
-
WellSpan HealthNeuraptive Therapeutics Inc.RecruitingInjury of Other Nerves at Wrist and Hand Level of Unspecified Arm, Initial EncounterUnited States
-
University of California, San FranciscoNational Cancer Institute (NCI); Food and Drug Administration (FDA)CompletedAdverse Effect of Other Agents Primarily Affecting the Cardiovascular System, Initial EncounterUnited States
-
Federal University of Minas GeraisCompletedUnspecified Injury of Brachial Artery, Left Side, Initial EncounterBrazil
-
Lithuanian University of Health SciencesUnknownAdverse Effect of Oral Contraceptives, Initial EncounterLithuania
-
Cai LiUnknownInjury of Other and Multiple Parts of Small IntestineChina
-
Orthox LimitedUniversity of Bristol; Avon Orthopaedic Centre, North Bristol NHS Trust, Bristol...TerminatedOther Tear of Medial Meniscus, Current InjuryUnited Kingdom
-
PfizerCompletedCandidemia | Other Forms of Candida Infections(Intra-abdominal Abscess, Peritonitis)Korea, Republic of
-
Xinhua Hospital, Shanghai Jiao Tong University...UnknownInjury of Facial Nerve, Unspecified Side, Initial Encounter
-
Indiana UniversityRecruitingTraumatic Brain Injury | Concussion, Severe | Concussion, Intermediate | Concussion With Brief Loss of Consciousness | Traumatic Brain Injury With Brief Loss of Consciousness | Traumatic Brain Injury With No Loss of Consciousness | Concussion With LOC 31 to 59 Minutes | Traumatic Brain Injury With... and other conditionsUnited States
-
Turku University HospitalCompletedGastrointestinal Diseases | Intra-abdominal Infection | Acute Disease | Appendicitis | Other and Unspecified Acute AppendicitisFinland
Clinical Trials on Definitive Closure Laparotomy
-
University Hospital, GhentJohnson & JohnsonCompleted
-
Mesh Suture Inc.University of Maryland; Walter Reed National Military Medical Center; Uniformed...WithdrawnLaparotomy | Suture; Complications, Mechanical | Hernia Incisional
-
Uniformed Services University of the Health SciencesWithdrawnSuture, Complication | Hernia IncisionalUnited States
-
Fernandez ZamoraRecruitingColorectal Cancer | Wound Infection | Incisional HerniaSpain
-
Tanta UniversityRecruitingVentral Hernia | Incisional Hernia | Abdominal Wall WoundEgypt
-
University of BelgradeUnknownMortality | Acute PancreatitisSerbia
-
Contamac LtdHartwig Research CenterCompleted
-
Cancer Institute and Hospital, Chinese Academy...CompletedEsophageal NeoplasmsChina
-
Karolinska InstitutetUniversity of StellenboschCompletedPenetrating Abdominal TraumaSouth Africa
-
Inonu UniversityUnknownSmall/Large Bowel