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Randomized intraoperative peritoneal lavage for traumatic abdominal injuries

A randomized controlled trial on intrabdominal irrigation during emergency trauma laparotomy

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN66454589
Enrollment
204
Registered
2017-09-26
Start date
2002-04-01
Completion date
Unknown
Last updated
2020-12-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Traumatic Abdominal injuries Injury, Occupational Diseases, Poisoning Traumatic Abdominal injuries

Interventions

Once all operative repair is completed (including restoring intestinal continuity) and a decision to perform primary closure of the abdomen is made, the patients undergo random assignment to one of th

Sponsors

University of Illinois at Chicago
Lead Sponsor
Advocate Health Care
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients aged 14 and above 2. Requiring an emergent exploratory laparotomy for trauma

Exclusion criteria

Exclusion criteria: 1. Included the need for concomitant extra-abdominal surgery 2. The presence of a pelvic fracture and severe TBI (GCS <6 noted during the primary survey) 3. The use of the open abdomen technique 4. Intrabdominal vascular implants (but not primary repairs) 5. The presence of diaphragmatic injuries

Design outcomes

Primary

MeasureTime frame
30 day mortality is measured using the electronic medical record of the patient to retrieve the date of death, at the 30 day period or the day of death, whichever occurred first.

Secondary

MeasureTime frame
1. Intra-abdominal abscess is measured using the radiologic electronic medical record of the patient at the day of diagnosis or at 30 days, whichever occurred first 2. Wound infection is measured using the data about daily visual inspection of the wound and the criteria available in the methodology section of the protocol, using the electronic medical record of the patient at the day of diagnosis or at 30 days, whichever occurred first 3. Fistula formation is measured using the data about daily visual inspection of the wound and the criteria available in the methodology section of the protocol, using the electronic medical record of the patient at the day of diagnosis or at 30 days, whichever occurred first 4. Evisceration is measured using the data about daily visual inspection of the wound and the criteria available in the methodology section of the protocol, and the resultant operative report, using the electronic medical record of the patient at the day of diagnosis or at 30 days, whichever occurred first

Countries

United States of America

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 24, 2026