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NOT YET RECRUITING
NCT06871787
PHASE4

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

Sponsor: Istanbul University

View on ClinicalTrials.gov

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.

Official title: Evaluation of Bowel Anastomoses During Gynecologic Oncology Surgery Using Near-Infrared Fluorescence Imaging With Indocyanine Green

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2025-09-01

Completion Date

2027-12-30

Last Updated

2025-03-14

Healthy Volunteers

No

Interventions

DRUG

Indocyanine Green

Indocyanine green (ICG), administered intravenously at a dose of 2.5 mg/ml, will be used during surgery to evaluate bowel anastomosis perfusion through near-infrared fluorescence imaging.

DEVICE

Near-Infrared Fluorescence Imaging System

A near-infrared fluorescence imaging device will be used intraoperatively to visualize indocyanine green (ICG) fluorescence, assessing the perfusion of bowel anastomoses during gynecologic oncology surgery.

Locations (1)

Istanbul University, Istanbul Faculty of Medicine, Department of Gynecologic Oncology

Istanbul, Istanbul, Turkey (Türkiye)