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Completed
NCT07826156
ICG Fluorescence Angiography to Reduce Anastomotic Leak After Laparoscopic Colorectal Resection
Conditions: Colorectal Disease Requiring Elective Laparoscopic Resection, Colorectal Anastomotic Leak
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 120
Sponsor: Alexandria University
Location: Alexandria Main University Hospital Alexandria
Summary
This prospective randomized controlled trial evaluates whether intraoperative indocyanine green (ICG) fluorescence angiography reduces clinically significant anastomotic leakage after elective laparoscopic colorectal resection with primary anastomosis. A total of 120 adults were allocated in a 1:1 ratio to ICG-guided perfusion assessment or standard visual perfusion assessment, with 60 participants in each group. In the ICG arm, ICG 0.2 mg/kg was administered intravenously after bowel mobilization and before transection, and near-infrared imaging guided selection of a well-perfused transection margin. Participants were followed for 90 days after surgery for grade B or C anastomotic leakage.
Eligibility Criteria
Inclusion Criteria:
* Adults aged 18 years or older.
* Undergoing elective laparoscopic colorectal resection.
* Planned primary colorectal anastomosis.
* Able and willing to provide written informed consent.
Exclusion Criteria:
* Known allergy to iodine or indocyanine green.
* Severe hepatic dysfunction.
* Severe renal dysfunction.
* Emergency colorectal resection.
* Inflammatory bowel disease requiring extensive resection.
* Previous colorectal surgery involving the planned anastomotic site.
Source: ClinicalTrials.gov (NCT07826156). StuddyBuddy aggregates publicly available trial information.