Other Injury of Other Intra-abdominal Organs, Initial Encounter
Conditions
Keywords
Exploratory Lap (Ex Lap), Damage Control Laparotomy (DCL), Definitive
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.
Interventions
PROCEDUREDefinitive Closure Laparotomy
Subjects randomized to the definitive closure laparotomy arm will have the incision closed at the end of the exploratory laparotomy.
PROCEDUREDamage 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.
Sponsors
National Center for Advancing Translational Sciences (NCATS)
The University of Texas Health Science Center, Houston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Died or Had Major Abdominal Complication (MAC) | 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
| Measure | Time frame | Description |
|---|---|---|
| Number of Hospital-free Days | 30 days | Number of days patient was not in hospital within the 30 day time frame. |
| Number of ICU-free Days | 30 days | Number of days patient not in the ICU during the 30 day time frame |
| Number of Ventilator-free Days | 30 days | Number of days patient not on ventilator in the 30 day time frame |
| Number of Participants With Non-abdominal Morbidities | 30 days | Non-abdominal Morbidities include Acute Kidney Failure, Deep Vein Thrombosis, Pulmonary Embolism, Pneumonia, and Urinary Tract Infection. |
| Patient-centered Outcomes Assessed Using the Standard Gamble | 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 5-level European Quality of Life Scale-5D (EuroQol-5D-5L) | 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. |
| Patient-centered Outcomes Assessed Using the Post-Traumatic Stress Disorder Check List - Civilian (PCL-C) | 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. |
| Hospital Costs | 30 days | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
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. | 18 |
| Definitive Closure Laparotomy Subjects randomized to the definitive closure laparotomy arm will have the incision closed at the end of the exploratory laparotomy.
Definitive Closure Laparotomy: Subjects randomized to the definitive closure laparotomy arm will have the incision closed at the end of the exploratory laparotomy. | 21 |
| Total | 39 |
Baseline characteristics
| Characteristic | Damage Control Laparotomy | Definitive Closure Laparotomy | Total |
|---|---|---|---|
| Age, Continuous | 32 years | 29 years | 30 years |
| Area of Injury Femur | 4 Participants | 4 Participants | 8 Participants |
| Area of Injury Kidney | 6 Participants | 7 Participants | 13 Participants |
| Area of Injury Large Bowel | 6 Participants | 7 Participants | 13 Participants |
| Area of Injury Liver | 10 Participants | 10 Participants | 20 Participants |
| Area of Injury Major Arterial Injury | 1 Participants | 0 Participants | 1 Participants |
| Area of Injury Major Venous Injury | 0 Participants | 1 Participants | 1 Participants |
| Area of Injury Pancreas | 3 Participants | 7 Participants | 10 Participants |
| Area of Injury Pelvis | 7 Participants | 8 Participants | 15 Participants |
| Area of Injury Small Bowel | 8 Participants | 9 Participants | 17 Participants |
| Area of Injury Spleen | 10 Participants | 11 Participants | 21 Participants |
| Area of Injury Stomach | 3 Participants | 5 Participants | 8 Participants |
| Area of Injury Traumatic Brain Injury | 5 Participants | 6 Participants | 11 Participants |
| Grade of Kidney Injury | 2 units on a scale | 4 units on a scale | 4 units on a scale |
| Grade of Liver Injury | 3 units on a scale | 2 units on a scale | 3 units on a scale |
| Grade of Spleen Injury | 3 units on a scale | 4 units on a scale | 3 units on a scale |
| Injury Severity Score (ISS) | 29 score on a scale | 34 score on a scale | 33 score on a scale |
| Mechanism of Injury Blunt | 10 Participants | 12 Participants | 22 Participants |
| Mechanism of Injury Penetrating | 8 Participants | 9 Participants | 17 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Black | 7 Participants | 3 Participants | 10 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Hispanic | 5 Participants | 7 Participants | 12 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Other | 0 Participants | 10 Participants | 10 Participants |
| Race/Ethnicity, Customized Race/Ethnicity White | 6 Participants | 1 Participants | 7 Participants |
| Region of Enrollment United States | 18 Participants | 21 Participants | 39 Participants |
| Score on Abbreviated Injury Scale (AIS) - Abdomen | 4 score on a scale | 3 score on a scale | 3 score on a scale |
| Score on Abbreviated Injury Scale (AIS) - Chest | 3 score on a scale | 3 score on a scale | 3 score on a scale |
| Score on Abbreviated Injury Scale (AIS) - Head | 0 score on a scale | 1 score on a scale | 0 score on a scale |
| Sex: Female, Male Female | 4 Participants | 4 Participants | 8 Participants |
| Sex: Female, Male Male | 14 Participants | 17 Participants | 31 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 18 | 7 / 21 |
| other Total, other adverse events | 6 / 18 | 7 / 21 |
| serious Total, serious adverse events | 11 / 18 | 16 / 21 |
Outcome results
Primary
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
Population: Analysis is intention to treat, so all who were assigned to the intervention are analyzed, regardless of whether they received the intervention.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Damage Control Laparotomy | Number of Participants Who Died or Had Major Abdominal Complication (MAC) | Death or Major abdominal complication (MAC) | 6 Participants |
| Damage Control Laparotomy | Number of Participants Who Died or Had Major Abdominal Complication (MAC) | Major abdominal complication (MAC) | 6 Participants |
| Damage Control Laparotomy | Number of Participants Who Died or Had Major Abdominal Complication (MAC) | Death | 0 Participants |
| Definitive Closure Laparotomy | Number of Participants Who Died or Had Major Abdominal Complication (MAC) | Death or Major abdominal complication (MAC) | 12 Participants |
| Definitive Closure Laparotomy | Number of Participants Who Died or Had Major Abdominal Complication (MAC) | Major abdominal complication (MAC) | 8 Participants |
| Definitive Closure Laparotomy | Number of Participants Who Died or Had Major Abdominal Complication (MAC) | Death | 7 Participants |
Secondary
Hospital Costs
Time frame: 30 days
Secondary
Number of Hospital-free Days
Number of days patient was not in hospital within the 30 day time frame.
Time frame: 30 days
Population: Analysis is intention to treat, so all who were assigned to the intervention are analyzed, regardless of whether they received the intervention.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Damage Control Laparotomy | Number of Hospital-free Days | 13 days |
| Definitive Closure Laparotomy | Number of Hospital-free Days | 0 days |
Secondary
Number of ICU-free Days
Number of days patient not in the ICU during the 30 day time frame
Time frame: 30 days
Population: Analysis is intention to treat, so all who were assigned to the intervention are analyzed, regardless of whether they received the intervention.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Damage Control Laparotomy | Number of ICU-free Days | 24 days |
| Definitive Closure Laparotomy | Number of ICU-free Days | 12 days |
Secondary
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
Population: Analysis is intention to treat, so all who were assigned to the intervention are analyzed, regardless of whether they received the intervention.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Damage Control Laparotomy | Number of Participants With Non-abdominal Morbidities | Number of Participants with Deep Vein Thrombosis | 0 Participants |
| Damage Control Laparotomy | Number of Participants With Non-abdominal Morbidities | Number of Participants with Pneumonia | 6 Participants |
| Damage Control Laparotomy | Number of Participants With Non-abdominal Morbidities | Number of Participants with Pulmonary Embolism | 1 Participants |
| Damage Control Laparotomy | Number of Participants With Non-abdominal Morbidities | Number of Participants with Urinary Tract Infection | 3 Participants |
| Damage Control Laparotomy | Number of Participants With Non-abdominal Morbidities | Number of Participants with Acute Kidney Failure | 3 Participants |
| Definitive Closure Laparotomy | Number of Participants With Non-abdominal Morbidities | Number of Participants with Urinary Tract Infection | 1 Participants |
| Definitive Closure Laparotomy | Number of Participants With Non-abdominal Morbidities | Number of Participants with Acute Kidney Failure | 7 Participants |
| Definitive Closure Laparotomy | Number of Participants With Non-abdominal Morbidities | Number of Participants with Deep Vein Thrombosis | 2 Participants |
| Definitive Closure Laparotomy | Number of Participants With Non-abdominal Morbidities | Number of Participants with Pulmonary Embolism | 1 Participants |
| Definitive Closure Laparotomy | Number of Participants With Non-abdominal Morbidities | Number of Participants with Pneumonia | 8 Participants |
Secondary
Number of Ventilator-free Days
Number of days patient not on ventilator in the 30 day time frame
Time frame: 30 days
Population: Analysis is intention to treat, so all who were assigned to the intervention are analyzed, regardless of whether they received the intervention.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Damage Control Laparotomy | Number of Ventilator-free Days | 27 days |
| Definitive Closure Laparotomy | Number of Ventilator-free Days | 22 days |
Secondary
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
Population: These data were not collected from 5 in the Damage control laparotomy arm and 9 in the Definitive closure laparotomy arm.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Damage Control Laparotomy | Patient-centered Outcomes Assessed Using the 5-level European Quality of Life Scale-5D (EuroQol-5D-5L) | 55 score on a scale | Standard Deviation 36 |
| Definitive Closure Laparotomy | Patient-centered Outcomes Assessed Using the 5-level European Quality of Life Scale-5D (EuroQol-5D-5L) | 49 score on a scale | Standard Deviation 40 |
Secondary
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)
Population: These data were not collected from 2 in the Damage control laparotomy arm and 9 in the Definitive closure laparotomy arm.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Damage Control Laparotomy | Patient-centered Outcomes Assessed Using the 5-level European Quality of Life Scale-5D (EuroQol-5D-5L) | 19 score on a scale | Standard Deviation 33 |
| Definitive Closure Laparotomy | Patient-centered Outcomes Assessed Using the 5-level European Quality of Life Scale-5D (EuroQol-5D-5L) | 25 score on a scale | Standard Deviation 33 |
Secondary
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
Population: These data were not collected from 7 in the Damage control laparotomy arm and 8 in the Definitive closure laparotomy arm.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Damage Control Laparotomy | Patient-centered Outcomes Assessed Using the Post-Traumatic Stress Disorder Check List - Civilian (PCL-C) | 39 score on a scale | Standard Deviation 16 |
| Definitive Closure Laparotomy | Patient-centered Outcomes Assessed Using the Post-Traumatic Stress Disorder Check List - Civilian (PCL-C) | 31 score on a scale | Standard Deviation 11 |
Secondary
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)
Population: These data were not collected from 5 in the Damage control laparotomy arm and 9 in the Definitive closure laparotomy arm.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Damage Control Laparotomy | Patient-centered Outcomes Assessed Using the Post-Traumatic Stress Disorder Check List - Civilian (PCL-C) | 35 score on a scale | Standard Deviation 14 |
| Definitive Closure Laparotomy | Patient-centered Outcomes Assessed Using the Post-Traumatic Stress Disorder Check List - Civilian (PCL-C) | 32 score on a scale | Standard Deviation 15 |
Secondary
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)
Population: These data were not collected from 6 in the Damage control laparotomy arm and 10 in the Definitive closure laparotomy arm.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Damage Control Laparotomy | Patient-centered Outcomes Assessed Using the Standard Gamble | 2.2 score on a scale | Standard Deviation 5 |
| Definitive Closure Laparotomy | Patient-centered Outcomes Assessed Using the Standard Gamble | 0.4 score on a scale | Standard Deviation 1 |
Secondary
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
Population: These data were not collected from 6 in the Damage control laparotomy arm and 9 in the Definitive closure laparotomy arm.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Damage Control Laparotomy | Patient-centered Outcomes Assessed Using the Standard Gamble | 9.5 score on a scale | Standard Deviation 16.8 |
| Definitive Closure Laparotomy | Patient-centered Outcomes Assessed Using the Standard Gamble | 1.7 score on a scale | Standard Deviation 12.7 |