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.
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.
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.
Single group
Indocyanine Green
DrugIndocyanine 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
DeviceA 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.
Rate of Anastomotic Complications within 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.
Number of Anastomoses Revised After Indocyanine Green Fluorescence Imaging
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.
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
