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| ID | Type | Description | Link |
|---|---|---|---|
| UL1TR000371 | U.S. NIH Grant/Contract | View source | |
| KL2TR000370 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Advancing Translational Sciences (NCATS) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Definitive closure laparotomy | Active Comparator | Subjects randomized to the definitive closure laparotomy arm will have the incision closed at the end of the exploratory laparotomy. |
|
| Damage control laparotomy | Other | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Definitive Closure Laparotomy | Procedure | Subjects randomized to the definitive closure laparotomy arm will have the incision closed at the end of the exploratory laparotomy. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Indication for DCL for which there is no surgeon equipoise:
Indication for DEF for which there is no surgeon equipoise:
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
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| Name | Affiliation | Role |
|---|---|---|
| John Harvin, MD | The University of Texas Health Science Center, Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Hermann Hospital - Texas Medical Center | Houston | Texas | 77030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29766087 | Background | Harvin JA, Podbielski J, Vincent LE, Fox EE, Moore LJ, Cotton BA, Wade CE, Holcomb JB. Damage control laparotomy trial: design, rationale and implementation of a randomized controlled trial. Trauma Surg Acute Care Open. 2017 Apr 13;2(1):e000083. doi: 10.1136/tsaco-2017-000083. eCollection 2017. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | Analysis is intention to treat, so all who were assigned to the intervention are analyzed, regardless of whether they received the intervention. | Posted | Count of Participants | Participants | 30 days |
|
From time of hospital admission to time of discharge from hospital (about 8 to 31 days)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | General disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ileus | Gastrointestinal disorders | Systematic Assessment |
Small sample size; failure to accrue targeted sample size of 56; inability to blind; imbalance of baseline characteristics in randomized arms
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| John A. Harvin, MD, FACS, Associate Professor | The University of Texas Health Science Center at Houston | (713) 500-7244 | John.Harvin@uth.tmc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 26, 2018 | Oct 18, 2021 | Prot_SAP_000.pdf |
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| Damage Control Laparotomy | Procedure | 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 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 |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Mechanism of Injury | Count of Participants | Participants |
|
| Area of Injury | Count of Participants | Participants |
|
| Grade of Liver Injury | Grade ranges from 1 to 5, with a higher grade indicating worse injury | Median | Inter-Quartile Range | units on a scale |
|
| Grade of Spleen Injury | Grade ranges from 1 to 5, with a higher grade indicating worse injury | Median | Inter-Quartile Range | units on a scale |
|
| Grade of Kidney Injury | Grade ranges from 1 to 5, with a higher grade indicating worse injury | Median | Inter-Quartile Range | units on a scale |
|
| Score on Abbreviated Injury Scale (AIS) - Head | The AIS classifies individual injuries by body region as follows: 0 = No Injury; 1 = Minor; 2 = Moderate; 3 = Serious; 4 = Severe; 5 = Critical; 6 = Maximal (currently untreatable) | Median | Inter-Quartile Range | score on a scale |
|
| Score on Abbreviated Injury Scale (AIS) - Chest | The AIS classifies individual injuries by body region as follows: 0 = No Injury; 1 = Minor; 2 = Moderate; 3 = Serious; 4 = Severe; 5 = Critical; 6 = Maximal (currently untreatable) | Median | Inter-Quartile Range | score on a scale |
|
| Score on Abbreviated Injury Scale (AIS) - Abdomen | The AIS classifies individual injuries by body region as follows: 0 = No Injury; 1 = Minor; 2 = Moderate; 3 = Serious; 4 = Severe; 5 = Critical; 6 = Maximal (currently untreatable) | Median | Inter-Quartile Range | score on a scale |
|
| Injury Severity Score (ISS) | The Injury Severity Score (ISS) assesses the combined effects of injuries in multiple anatomical locations and ranges from from 1 to 75, with 75 being the most severe. | Median | Inter-Quartile Range | score on a scale |
|
| OG001 | 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. |
|
|
| 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. | Analysis is intention to treat, so all who were assigned to the intervention are analyzed, regardless of whether they received the intervention. | Posted | Count of Participants | Participants | 30 days |
|
|
|
| Secondary | Number of Hospital-free Days | Number of days patient was not in hospital within the 30 day time frame. | Analysis is intention to treat, so all who were assigned to the intervention are analyzed, regardless of whether they received the intervention. | Posted | Median | Inter-Quartile Range | days | 30 days |
|
|
|
| Secondary | Number of ICU-free Days | Number of days patient not in the ICU during the 30 day time frame | Analysis is intention to treat, so all who were assigned to the intervention are analyzed, regardless of whether they received the intervention. | Posted | Median | Inter-Quartile Range | days | 30 days |
|
|
|
| Secondary | Number of Ventilator-free Days | Number of days patient not on ventilator in the 30 day time frame | Analysis is intention to treat, so all who were assigned to the intervention are analyzed, regardless of whether they received the intervention. | Posted | Median | Inter-Quartile Range | days | 30 days |
|
|
|
| Secondary | Hospital Costs | Not Posted | 30 days | Participants |
| 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. | These data were not collected from 6 in the Damage control laparotomy arm and 10 in the Definitive closure laparotomy arm. | Posted | Mean | Standard Deviation | score on a scale | at discharge from hospital (about 20 days after intervention) |
|
|
|
| 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. | These data were not collected from 6 in the Damage control laparotomy arm and 9 in the Definitive closure laparotomy arm. | Posted | Mean | Standard Deviation | score on a scale | 6 months after discharge from hospital |
|
|
|
| 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. | These data were not collected from 2 in the Damage control laparotomy arm and 9 in the Definitive closure laparotomy arm. | Posted | Mean | Standard Deviation | score on a scale | at discharge from hospital (about 20 days after intervention) |
|
|
|
| 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. | These data were not collected from 5 in the Damage control laparotomy arm and 9 in the Definitive closure laparotomy arm. | Posted | Mean | Standard Deviation | score on a scale | 6 months after discharge from hospital |
|
|
|
| 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. | These data were not collected from 5 in the Damage control laparotomy arm and 9 in the Definitive closure laparotomy arm. | Posted | Mean | Standard Deviation | score on a scale | at discharge from hospital (about 20 days after intervention) |
|
|
|
| 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. | These data were not collected from 7 in the Damage control laparotomy arm and 8 in the Definitive closure laparotomy arm. | Posted | Mean | Standard Deviation | score on a scale | 6 months after discharge from hospital |
|
|
|
| 0 |
| 18 |
| 11 |
| 18 |
| 6 |
| 18 |
| EG001 | 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. | 7 | 21 | 16 | 21 | 7 | 21 |
| Organ/space surgical site infection | Infections and infestations | Systematic Assessment |
|
| Fascial dehiscence | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Reopening after closure | Surgical and medical procedures | Systematic Assessment |
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| Sepsis | Immune system disorders | Systematic Assessment |
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| Acute renal failure | Renal and urinary disorders | Systematic Assessment |
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| Multi-organ failure | General disorders | Systematic Assessment |
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| Pulmonary embolus | Vascular disorders | Systematic Assessment |
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| Deep vein thrombosis | Vascular disorders | Systematic Assessment |
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| Superficial surgical site infection | Infections and infestations | Systematic Assessment |
|
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| Number of Participants with Pulmonary Embolism |
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| Number of Participants with Pneumonia |
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| Number of Participants with Urinary Tract Infection |
|