Other Injury of Other Intra-abdominal Organs, Initial EncounterNCT02706041

Damage Control Laparotomy

A study testing Definitive Closure Laparotomy in people with Other Injury of Other Intra-abdominal Organs, Initial Encounter, run by The University of Texas Health Science Center, Houston at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

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

Who is it for?: Ages 16 years and older
Conditions the study is for: Other Injury of Other Intra-abdominal Organs, Initial Encounter
What is being tested?: Definitive Closure Laparotomy
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 39 participants
Where: 1 siteUnited States
Study dates: 1 Jul 2016to 30 Apr 2020
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 16 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

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)

Who cannot join

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:

Show all 13Show fewer

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 locations and contacts

1 site in 1 country.

United States1 site

Memorial Hermann Hospital - Texas Medical Center
Houston, Texas, 77030

Other trials in United States

About this study

Official title: Damage Control Laparotomy: A Randomized Controlled Trial

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

Read the 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.

Conditions: Other Injury of Other Intra-abdominal Organs, Initial Encounter
Being tested: Definitive Closure Laparotomy, Damage Control Laparotomy
Keywords: Exploratory Lap (Ex Lap), Damage Control Laparotomy (DCL), Definitive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Definitive Closure LaparotomyProcedure or surgery
Subjects randomized to the definitive closure laparotomy arm will have the incision closed at the end of the exploratory laparotomy.
Damage Control LaparotomyProcedure or surgery
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.

Study groups in NCT02706041
Study group	Role	What they receive
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. Receives: Procedure: Definitive Closure 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. Receives: Procedure: Damage Control Laparotomy

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: 30 days

Secondary outcomes (11)

Number of Participants With Non-abdominal Morbidities
Non-abdominal Morbidities include Acute Kidney Failure, Deep Vein Thrombosis, Pulmonary Embolism, Pneumonia, and Urinary Tract Infection.
Measured: 30 days
Number of Hospital-free Days
Number of days patient was not in hospital within the 30 day time frame.
Measured: 30 days
Number of ICU-free Days
Number of days patient not in the ICU during the 30 day time frame
Measured: 30 days
Number of Ventilator-free Days
Number of days patient not on ventilator in the 30 day time frame
Measured: 30 days
Hospital Costs
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 months after discharge from hospital

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jul 201630 Apr 2020

First posted11 Mar 2016 (estimated)
Study start1 Jul 2016
Primary completion30 Nov 2019
Study completion30 Apr 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Other Injury of Other Intra-abdominal Organs, Initial EncounterStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 39 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02706041
Sponsor's protocol ID: HSC-GEN-16-0104
Other IDs: UL1TR000371, KL2TR000370
Status last verified: Oct 2021
First submitted: 27 Feb 2016
Last updated: 18 Nov 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 29766087

Study at a glance

From the registry record, last updated by the sponsor on 18 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Damage Control Laparotomy: A Randomized Controlled Trial
ClinicalTrials.gov ID: NCT02706041
Acronym / sponsor ID: HSC-GEN-16-0104
Conditions: Other Injury of Other Intra-abdominal Organs, Initial Encounter
Keywords: Exploratory Lap (Ex Lap), Damage Control Laparotomy (DCL), Definitive
Study type: Interventional
Recruitment status: Completed
Enrolment: 39 participants (actual)
Lead sponsor: The University of Texas Health Science Center, HoustonUniversity, hospital or other
Collaborators: National Center for Advancing Translational Sciences (NCATS)
Study start: 1 Jul 2016 (actual)
Primary completion: 30 Nov 2019 (actual)
Study completion: 30 Apr 2020 (actual)
First posted: 11 Mar 2016 (estimated)
Results: Posted 18 Nov 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Definitive closure laparotomy	Active comparator	Procedure: Definitive Closure LaparotomySubjects randomized to the definitive closure laparotomy arm will have the incision closed at the end of the exploratory laparotomy.
Damage control laparotomy	Other	Procedure: Damage Control LaparotomySubjects 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.

Who may qualify

Ages: 16 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (3 listed)

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)

Key exclusion criteria (13 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Definitive Closure LaparotomySubjects randomized to the definitive closure laparotomy arm will have the incision closed at the end of the exploratory laparotomy.	Procedure or surgery	Definitive closure laparotomy
Damage Control LaparotomySubjects 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 or surgery	Damage control laparotomy

Primary outcome

Number of Participants Who Died or Had Major Abdominal Complication (MAC)
Time frame: 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).

11 secondary outcomes

Number of Participants With Non-abdominal Morbidities
Time frame: 30 days
Number of Hospital-free Days
Time frame: 30 days
Number of ICU-free Days
Time frame: 30 days
Number of Ventilator-free Days
Time frame: 30 days
Hospital Costs
Time frame: 30 days
Patient-centered Outcomes Assessed Using the Standard Gamble
Time frame: at discharge from hospital (about 20 days after intervention)
Patient-centered Outcomes Assessed Using the Standard Gamble
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)
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)
Time frame: 6 months after discharge from hospital
Patient-centered Outcomes Assessed Using the Post-Traumatic Stress Disorder Check List - Civilian (PCL-C)
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)
Time frame: 6 months after discharge from hospital

Results and safety

Results posted to the registry on 18 Nov 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Damage Control Laparotomy	18	18
Definitive Closure Laparotomy	21	18

Primary outcome: Number of Participants Who Died or Had Major Abdominal Complication (MAC)

Time frame: 30 days. Count of participants. Unit: Participants

Measure	Damage Control Laparotomy n = 18	Definitive Closure Laparotomy n = 21
Death or Major abdominal complication (MAC)	6	12
Major abdominal complication (MAC)	6	8
Death	0	7

Population analysed: Analysis is intention to treat, so all who were assigned to the intervention are analyzed, regardless of whether they received the intervention.

11 secondary outcomes are reported in the full results.

Adverse events

Time frame: From time of hospital admission to time of discharge from hospital (about 8 to 31 days). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Damage Control Laparotomy	11 of 18 (61.1%)	6 of 18 (33.3%)	0 of 18
Definitive Closure Laparotomy	16 of 21 (76.2%)	7 of 21 (33.3%)	7 of 21

Limitations and caveats (from the sponsor): Small sample size; failure to accrue targeted sample size of 56; inability to blind; imbalance of baseline characteristics in randomized arms

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 29766087Harvin 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.
Individual participant dataSharing planned: No

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

John Harvin, MD principal investigator

The University of Texas Health Science Center, Houston

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Nov 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Who Died or Had Major Abdominal Complication (MAC) (time frame: 30 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02706041, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2021.