Clinical Trial

Near-Infrared Fluorescence Imaging With Indocyanine Green to Evaluate Bowel Anastomoses in Gynecologic Oncology Surgery

Study acronym: INOCA
Not Yet Recruiting Phase 4
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Summary
The goal of this study is to evaluate if indocyanine green (ICG) fluorescence imaging helps reduce complications in bowel surgery performed during gynecologic cancer operations. The main question it aims to answer is: Does using ICG fluorescence imaging during bowel anastomosis reduce the rate of complications such as leaks, infections, and abscesses within 30 days after surgery? Participants are women aged 18 and older undergoing surgery for gynecologic cancers (such as ovarian, uterine, cervical, or vulvar cancer). During surgery, investigators will inject ICG intravenously, then use a special near-infrared camera to see how well blood flows at the anastomosis site. The investigators will then decide if the reconnection is good enough or needs adjustment. Researchers will record any complications within the first 30 days after surgery to understand if this imaging method helps reduce surgical risks.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-03-06.
Trial Details
NCT Number NCT06871787
Lead Sponsor Istanbul University
Conditions Gynecologic Cancers, Ovarian Cancer, Endometrial Cancers, Cervical Cancers, Vulvar Cancer, Anastomotic Leaks
Enrollment 50 participants
Start Date 2025-09-01
Primary Completion 2027-09-01 (estimated)
Study Completion 2027-12-30 (estimated)
Updated on ClinicalTrials.gov 2025-03-14