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

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age18+
SponsorIstanbul University

About this trial

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 criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Indocyanine Green
  • Near-Infrared Fluorescence Imaging System

Treatment groups

50 Participants
are divided into 1 treatment group

Sponsors and collaborators