Feasibility and Usability of Intraoperative Fluorescent Angiography With Indocyanine Green in Penetrating Abdominal Trauma

NCT04534816 | Completed

• 1 other identifier: 11068
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The surgical management of penetrating bowel and intestinal injuries, inflicted via a gunshot or knife stabbing, has long been a topic of debate \[1-3\]. The surgical management principally consists of: (i) primary repair; (ii) primary diversion or (iii) an initial abbreviated so called "damage control" operation followed by a definitive surgical intervention once the patient is stabilized \[4-9\] . Different classifications systems have been proposed to help determine the best operative option \[2,3,10-14\], but intestinal injuries can be difficult to manage and despite improvements in the diagnostics and treatment of penetrating abdominal trauma, high mortality and morbidity rates are prevalent \[15,16\]. In order to determine the correct surgical option an accurate determination of intestinal viability is essential. But clinically assessing regional perfusion is challenging and surgeons' clinical risk assessment of anastomotic leaks have shown a low predictive value \[17\]. Hence, there is a need for more precise diagnostic tool helping the surgeon in assessing intestinal viability the extent of intestinal injury. Indocyanine green (ICG) fluorescence angiography (ICG-FA) is an applied method for to assessing visceral perfusion worldwide. The obtained fluorescent signal after intravenous injection, is considered proportional to blood flow, thus aiding the surgeon to detect and address inadequate regional perfusion, despite satisfactory macroscopic appearance, intraoperatively \[18-21\]. Hence, the use of perioperative ICG-FA, has reduced the risk of anastomotic leaks after esophageal and colorectal surgery \[22-25\] and in the setting of acute mesenteric ischemia, significantly reduced the extent of intestinal resection \[26\]. In retrospective review of 186 war related trauma cases the use of ICG-FA was deemed useful however only 9 of these cases were truncal/abdomen/gastrointestinal and no objective definition of usability was provided \[27\]. Hence, data on the usability and feasibility of ICG-FA for in penetrating abdominal trauma is limited and to our knowledge has not been investigate in a civilian population previously. The present study aimed to investigate the usability and feasibility of ICG-FA in patients undergoing open abdominal exploration for penetrating abdominal trauma

Conditions

Abdominal Injuries

Keywords

ICG; intestinal injury; gunshot

Outcome Measures

Primary Outcomes (1)

• Feasibility and usability of ICG-FA

  Feasibility is defined as the completion rates of the ICG angiography. For each ICG assessment, the operating surgeon will be asked to fill out the widely used System Usability Scale (SUS®).

  through study completion, an average of 1 year

Secondary Outcomes (1)

• Surgical management

  through study completion, an average of 1 year

Study Arms (1)

Indocyanine Green

EXPERIMENTAL

patients abdominal injuries and repair will be investigated using Indocyanine Green

Diagnostic Test: Indocyanine Green

Interventions

Indocyanine Green DIAGNOSTIC_TEST

Perfusion assessments

Indocyanine Green

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients (above 18 years) scheduled for emergency laparotomy due to penetrating abdominal trauma

You may not qualify if:

• Allergy towards; iodine, indocyanine green or shellfish
• Liver insufficiency
• Thyrotoxicosis
• Pregnancy or lactation
• Legally incompetent for any reason

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (1)

Tygerberg Hospital

Cape Town, South Africa

Location

Related Publications (1)

• Patel MQ, Osterkamp JT, Buitendag JJ, Forgan TR, Steyn E. Indocyanine green fluorescence angiography in the management of intestinal injuries following penetrating abdominal trauma: a case-control study comparing postoperative outcomes. Int J Surg. 2024 Dec 1;110(12):7624-7629. doi: 10.1097/JS9.0000000000002096.

  PMID: 39434689 DERIVED

MeSH Terms

Conditions

Abdominal Injuries

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• Michael P Achiam, DMSci

  Rigshospitalet, Denmark

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D

Model Details: Pending patient acceptance all are eligible for inclusion

Study Record Dates

• First Submitted: August 24, 2020
• First Posted: September 1, 2020
• Study Start: March 12, 2020
• Primary Completion: August 31, 2020
• Study Completion: September 30, 2020
• Last Updated: November 30, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

ZA (1)