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

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

Status
Not yet recruiting
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06871787
Acronym
INOCA
Enrollment
50
Registered
2025-03-12
Start date
2025-09-01
Completion date
2027-12-30
Last updated
2025-03-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anastomotic Leaks, Cervical Cancers, Endometrial Cancers, Gynecologic Cancers, Ovarian Cancer, Vulvar Cancer

Keywords

Indocyanine Green, Near-Infrared Imaging, Bowel Anastomosis, Gynecologic Oncology, Anastomotic Complications, Perfusion Assessment

Brief 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.

Detailed description

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.

Interventions

DRUGIndocyanine 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.

DEVICENear-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.

Sponsors

Istanbul University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
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.

Design outcomes

Primary

MeasureTime frameDescription
Rate of Anastomotic Complications within 30 Days After Surgery30 days after surgeryThe 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

MeasureTime frameDescription
Number of Anastomoses Revised After Indocyanine Green Fluorescence ImagingIntraoperative (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.

Countries

Turkey (Türkiye)

Contacts

Primary ContactAtahan Toyran, Medical Doctor
atahan.toyran@istanbul.edu.tr+905057146233
Backup ContactYagmur Minareci, Assist. Prof.
dryagmurminareci@gmail.com+905053574361

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026