Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06871787

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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

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

Istanbul, 34093, Turkey (Türkiye)

Location contact

Atahan Toyran, Medical Doctor

SUB_INVESTIGATOR

Samet Topuz, Prof.

PRINCIPAL_INVESTIGATOR

Yagmur Minareci, Assist. Prof.

CONTACT

[email protected]

+905053574361

Yagmur Minareci, Assist. Prof.

SUB_INVESTIGATOR

About this study

In gynecologic cancer surgeries, complete removal of the tumor often requires bowel resection (removal of part of the intestine). After resection, surgeons perform bowel anastomosis to restore gastrointestinal continuity. However, anastomosis can sometimes fail, leading to complications such as leaks, pelvic abscesses, or infections. Such complications significantly affect patient health, recovery, and outcomes.

Indocyanine green (ICG) is a dye approved by health authorities for clinical use. When injected into the bloodstream, it glows brightly under near-infrared (NIR) light, allowing investigators to visually assess blood flow in tissues during surgery. Good blood flow is critical for proper healing of the bowel reconnection.

This study aims to evaluate the effectiveness of using ICG-enhanced NIR fluorescence imaging specifically during gynecologic oncology surgeries involving bowel resections. After surgeons complete the anastomosis, ICG will be administered intravenously. Investigators will then examine the blood flow at the anastomosis site using a special near-infrared camera. If the blood flow appears insufficient, investigators may choose to revise the bowel connection during the same operation.

The study will include approximately 50 women undergoing surgery for gynecologic cancers such as ovarian, uterine, cervical, or vulvar cancer. The primary goal is to determine whether the use of this imaging technique reduces complications, especially within the first 30 days after surgery.

The results of this research could lead to safer surgical procedures, improved patient outcomes, and potentially influence clinical practice guidelines in gynecologic oncology.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Indocyanine green

Drug

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

Device

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.

Primary outcomes

  1. Rate of Anastomotic Complications within 30 Days After Surgery

    Time frame: 30 days after surgery

    The primary outcome will be the incidence of anastomotic leaks, pelvic abscesses, and infections observed within 30 days following bowel anastomosis performed during gynecologic oncology surgery with indocyanine green-enhanced near-infrared fluorescence imaging.

Secondary outcomes

  1. Number of Anastomoses Revised After Indocyanine Green Fluorescence Imaging

    Time frame: Intraoperative (During Surgery)

    The secondary outcome will evaluate how frequently the bowel anastomosis site was revised intraoperatively due to insufficient perfusion as detected by indocyanine green-enhanced near-infrared fluorescence imaging.

Study contacts

Contact information is provided by the study sponsor or research team.

Atahan Toyran, Medical Doctor

CONTACT

[email protected]

+905057146233

Yagmur Minareci, Assist. Prof.

CONTACT

[email protected]

+905053574361

Sponsors and collaborators

Lead sponsor

Istanbul University

Other

Registry information

Official study title

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

Acronym: INOCA

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Mar 12, 2025
Registry last updated
Mar 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.