An interventional study of Definitive Closure Laparotomy and Damage Control Laparotomy in Other Injury of Other Intra-abdominal Organs, Initial Encounter, sponsored by The University of Texas Health Science Center, Houston. Completed at 1 site in United States. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2021-11-18.
Sponsored by The University of Texas Health Science Center, Houston · Not applicable, Interventional, and Treatment
Randomized study to compare outcomes of patients undergoing damage control laparotomies versus definitive closure for which there is surgeon equipoise to randomize.
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.
The University of Texas Health Science Center, Houston is the lead sponsor of 880 studies on the registry; 209 are open to participants now.
Of its 170 completed or terminated interventional studies of FDA-regulated products, 140 (82%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Indication for DCL for which there is no surgeon equipoise:
Indication for DEF for which there is no surgeon equipoise:
Subjects randomized to the definitive closure laparotomy arm will have the incision closed at the end of the exploratory laparotomy.
Procedure: Definitive Closure 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.
Procedure: Damage Control 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 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.
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).
Time frame: 30 days
Number of Participants With Non-abdominal Morbidities
Non-abdominal Morbidities include Acute Kidney Failure, Deep Vein Thrombosis, Pulmonary Embolism, Pneumonia, and Urinary Tract Infection.
Time frame: 30 days
Number of Hospital-free Days
Number of days patient was not in hospital within the 30 day time frame.
Time frame: 30 days
Number of ICU-free Days
Number of days patient not in the ICU during the 30 day time frame
Time frame: 30 days
Number of Ventilator-free Days
Number of days patient not on ventilator in the 30 day time frame
Time frame: 30 days
Hospital Costs
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 6 months after discharge from hospital
| Milestone | Damage Control Laparotomy | Definitive Closure Laparotomy |
|---|---|---|
| Started | 18 | 21 |
| Received allocated intervention | 18 | 18 |
| Completed | 18 | 18 |
| Not completed | 0 | 3 |
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).
| Participants | Damage Control Laparotomy | Definitive Closure Laparotomy |
|---|---|---|
| Death or Major abdominal complication (MAC) | 6 | 12 |
| Major abdominal complication (MAC) | 6 | 8 |
| Death | 0 | 7 |
Non-abdominal Morbidities include Acute Kidney Failure, Deep Vein Thrombosis, Pulmonary Embolism, Pneumonia, and Urinary Tract Infection.
| Participants | Damage Control Laparotomy | Definitive Closure Laparotomy |
|---|---|---|
| Number of Participants with Acute Kidney Failure | 3 | 7 |
| Number of Participants with Deep Vein Thrombosis | 0 | 2 |
| Number of Participants with Pulmonary Embolism | 1 | 1 |
| Number of Participants with Pneumonia | 6 | 8 |
| Number of Participants with Urinary Tract Infection | 3 | 1 |
Number of days patient was not in hospital within the 30 day time frame.
| days | Damage Control Laparotomy | Definitive Closure Laparotomy |
|---|---|---|
| Number of Hospital-free Days | 13 (0 to 19) | 0 (0 to 11) |
Number of days patient not in the ICU during the 30 day time frame
| days | Damage Control Laparotomy | Definitive Closure Laparotomy |
|---|---|---|
| Number of ICU-free Days | 24 (0 to 25) | 12 (0 to 24) |
Number of days patient not on ventilator in the 30 day time frame
| days | Damage Control Laparotomy | Definitive Closure Laparotomy |
|---|---|---|
| Number of Ventilator-free Days | 27 (3 to 28) | 22 (0 to 27) |
Results for this outcome have not been posted.
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.
| score on a scale | Damage Control Laparotomy | Definitive Closure Laparotomy |
|---|---|---|
| Patient-centered Outcomes Assessed Using the Standard Gamble | 2.2 ± 5.0 | 0.4 ± 1.0 |
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.
| score on a scale | Damage Control Laparotomy | Definitive Closure Laparotomy |
|---|---|---|
| Patient-centered Outcomes Assessed Using the Standard Gamble | 9.5 ± 16.8 | 1.7 ± 12.7 |
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.
| score on a scale | Damage Control Laparotomy | Definitive Closure Laparotomy |
|---|---|---|
| Patient-centered Outcomes Assessed Using the 5-level European Quality of Life Scale-5D (EuroQol-5D-5L) | 19 ± 33 | 25 ± 33 |
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.
| score on a scale | Damage Control Laparotomy | Definitive Closure Laparotomy |
|---|---|---|
| Patient-centered Outcomes Assessed Using the 5-level European Quality of Life Scale-5D (EuroQol-5D-5L) | 55 ± 36 | 49 ± 40 |
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.
| score on a scale | Damage Control Laparotomy | Definitive Closure Laparotomy |
|---|---|---|
| Patient-centered Outcomes Assessed Using the Post-Traumatic Stress Disorder Check List - Civilian (PCL-C) | 35 ± 14 | 32 ± 15 |
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.
| score on a scale | Damage Control Laparotomy | Definitive Closure Laparotomy |
|---|---|---|
| Patient-centered Outcomes Assessed Using the Post-Traumatic Stress Disorder Check List - Civilian (PCL-C) | 39 ± 16 | 31 ± 11 |
Collected over From time of hospital admission to time of discharge from hospital (about 8 to 31 days). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Damage Control Laparotomy | 0/18 (0%) | 11/18 (61.1%) | 6/18 (33.3%) |
| Definitive Closure Laparotomy | 7/21 (33.3%) | 16/21 (76.2%) | 7/21 (33.3%) |
| Event | Damage Control Laparotomy | Definitive Closure Laparotomy |
|---|---|---|
| SepsisImmune system disorders | 9/18 | 11/21 |
| Organ/space surgical site infectionInfections and infestations | 5/18 | 8/21 |
| DeathGeneral disorders | 0/18 | 7/21 |
| Acute renal failureRenal and urinary disorders | 3/18 | 7/21 |
| Reopening after closureSurgical and medical procedures | 2/18 | 6/21 |
| Multi-organ failureGeneral disorders | 4/18 | 6/21 |
| Fascial dehiscenceMusculoskeletal and connective tissue disorders | 0/18 | 4/21 |
| Event | Damage Control Laparotomy | Definitive Closure Laparotomy |
|---|---|---|
| IleusGastrointestinal disorders | 6/18 | 7/21 |
| Superficial surgical site infectionInfections and infestations | 1/18 | 4/21 |
| Deep vein thrombosisVascular disorders | 0/18 | 2/21 |
| Pulmonary embolusVascular disorders | 1/18 | 1/21 |
| Age, Continuous(years) | Damage Control Laparotomy | Definitive Closure Laparotomy | Total |
|---|---|---|---|
| Median | 32 (28 to 40) | 29 (24 to 48) | 30 (24 to 46) |
| Sex: Female, Male(Participants) | Damage Control Laparotomy | Definitive Closure Laparotomy | Total |
|---|---|---|---|
| Female | 4 | 4 | 8 |
| Male | 14 | 17 | 31 |
| Race/Ethnicity, Customized(Participants) | Damage Control Laparotomy | Definitive Closure Laparotomy | Total |
|---|---|---|---|
| Race/Ethnicity — Black | 7 | 3 | 10 |
| Race/Ethnicity — Hispanic | 5 | 7 | 12 |
| Race/Ethnicity — White | 6 | 1 | 7 |
| Race/Ethnicity — Other | 0 | 10 | 10 |
| Region of Enrollment(Participants) | Damage Control Laparotomy | Definitive Closure Laparotomy | Total |
|---|---|---|---|
| United States | 18 | 21 | 39 |
| Mechanism of Injury(Participants) | Damage Control Laparotomy | Definitive Closure Laparotomy | Total |
|---|---|---|---|
| Blunt | 10 | 12 | 22 |
| Penetrating | 8 | 9 | 17 |
| Area of Injury(Participants) | Damage Control Laparotomy | Definitive Closure Laparotomy | Total |
|---|---|---|---|
| Liver | 10 | 10 | 20 |
| Spleen | 10 | 11 | 21 |
| Kidney | 6 | 7 | 13 |
| Small Bowel | 8 | 9 | 17 |
| Large Bowel | 6 | 7 | 13 |
| Pancreas | 3 | 7 | 10 |
| Stomach | 3 | 5 | 8 |
| Major Venous Injury | 0 | 1 | 1 |
| Major Arterial Injury | 1 | 0 | 1 |
| Femur | 4 | 4 | 8 |
| Pelvis | 7 | 8 | 15 |
| Traumatic Brain Injury | 5 | 6 | 11 |
| Grade of Liver Injury(units on a scale) | Damage Control Laparotomy | Definitive Closure Laparotomy | Total |
|---|---|---|---|
| Median | 3 (2 to 3) | 2 (1 to 3) | 3 (2 to 3) |
| Grade of Spleen Injury(units on a scale) | Damage Control Laparotomy | Definitive Closure Laparotomy | Total |
|---|---|---|---|
| Median | 3 (1 to 3) | 4 (2 to 5) | 3 (2 to 4) |
5 further baseline measures are reported on the registry.
Documents are hosted by the registry — open the source record to download them.
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The University of Texas Health Science Center, Houston