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Clinical Trials in Turkey / NCT06871787
Starting soon Phase 4

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

NCT06871787 · tracked via the Priya Life Science Turkey tracker
Sponsor
Istanbul University
Phase
Phase 4
Started
2025-09-01
Last updated
2025-03-14

Condition(s) studied

Gynecologic CancersOvarian CancerEndometrial CancersCervical CancersVulvar CancerAnastomotic Leaks

Investigational drug(s) / intervention(s)

Indocyanine Green →Near-Infrared Fluorescence Imaging System

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.

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.

Study 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.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Female patients aged 18 years or older. * Diagnosis of gynecologic cancer (ovarian, endometrial, cervical, vulvar) requiring surgical treatment. * Planned bowel resection and anastomosis during gynecologic oncology surgery. * Ability and willingness to provide informed consent. Exclusion Criteria: * Known allergy or hypersensitivity to indocyanine green (ICG). * Pregnancy or breastfeeding at the time of surgery. * Severe liver or kidney dysfunction limiting the use of ICG.

Primary outcome measure(s)

Trial sites (1)

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

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Other trials for the same condition

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Prophylactic Subcutaneous Drainage After Gynecologic Oncology Midline Laparotomy Recruiting
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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06871787 on ClinicalTrials.gov ↗ ← All trials in Turkey