Damage Control Laparotomy

The University of Texas System (UT)

Status: Completed

Conditions: Other Injury of Other Intra-abdominal Organs, Initial Encounter

Treatments: Procedure: Damage Control Laparotomy; Procedure: Definitive Closure Laparotomy

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02706041

HSC-GEN-16-0104

UL1TR000371 (U.S. NIH Grant/Contract)

KL2TR000370 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

Randomized study to compare outcomes of patients undergoing damage control laparotomies versus definitive closure for which there is surgeon equipoise to randomize.

Full 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.

Enrollment: 39 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

39 participants in 2 patient groups

Definitive closure laparotomy

Active Comparator group

Description:

Subjects randomized to the definitive closure laparotomy arm will have the incision closed at the end of the exploratory laparotomy.

Treatment:

Procedure: Definitive Closure Laparotomy

Damage control laparotomy

Other group

Description:

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.

Treatment:

Procedure: Damage Control Laparotomy