N/A
N=39
Damage Control Laparotomy
Other Injury of Other Intra-abdominal Organs, Initial Encounter
Bottom Line
View on ClinicalTrials.gov: NCT02706041 ↗Enrolled (actual)
39
Serious AEs
69.2%
Results posted
Nov 2021
Primary outcome: Primary: Number of Participants Who Died or Had Major Abdominal Complication (MAC) — 6; 12; 6; 8 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Definitive Closure Laparotomy (Procedure); Damage Control Laparotomy (Procedure)
- Age
- Pediatric, Adult, Older Adult · 16+ yrs
- Sex
- All
- Sponsor
- The University of Texas Health Science Center, Houston
- Primary completion
- Nov 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Died or Had Major Abdominal Complication (MAC) |
6; 12; 6; 8; 0; 7 | — |
| SECONDARY Number of Participants With Non-abdominal Morbidities |
3; 7; 0; 2; 1; 1 | — |
| SECONDARY Number of Hospital-free Days |
13; 0 | — |
| SECONDARY Number of ICU-free Days |
24; 12 | — |
| SECONDARY Number of Ventilator-free Days |
27; 22 | — |
| SECONDARY Hospital Costs |
— | — |
| SECONDARY Patient-centered Outcomes Assessed Using the Standard Gamble |
9.5; 1.7 | — |
| SECONDARY Patient-centered Outcomes Assessed Using the Standard Gamble |
9.5; 1.7 | — |
| SECONDARY Patient-centered Outcomes Assessed Using the 5-level European Quality of Life Scale-5D (EuroQol-5D-5L) |
55; 49 | — |
| SECONDARY Patient-centered Outcomes Assessed Using the 5-level European Quality of Life Scale-5D (EuroQol-5D-5L) |
55; 49 | — |
| SECONDARY Patient-centered Outcomes Assessed Using the Post-Traumatic Stress Disorder Check List - Civilian (PCL-C) |
39; 31 | — |
| SECONDARY Patient-centered Outcomes Assessed Using the Post-Traumatic Stress Disorder Check List - Civilian (PCL-C) |
39; 31 | — |
Summary
Randomized study to compare outcomes of patients undergoing damage control laparotomies versus definitive closure for which there is surgeon equipoise to randomize.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02706041). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.