NCT07899125Not yet recruiting
FLuorescent Angiography in REduction of Anastomotic Leak in Rectal Cancer Surgery
Source: ClinicalTrials.gov · Last updated 27 Oct 2026
Brief summary (registry, in English)
The goal of this clinical trial is to find out whether using a special green dye called indocyanine green (ICG) during minimally invasive rectal cancer surgery can help surgeons assess blood flow to the bowel and reduce leakage from the surgical connection between two ends of the bowel. The main questions this study aims to answer are: * Does using ICG fluorescence imaging reduce the risk of leakage from the bowel connection after surgery? * Does ICG imaging help surgeons identify areas of the bowel with poor blood flow and decide whether the planned bowel connection needs to be changed? Researchers will compare ICG fluorescence-guided assessment with conventional visual assessment of bowel blood flow during rectal cancer surgery. Participants will: * Undergo planned minimally invasive rectal cancer surgery as part of their treatment. * Be randomly assigned during surgery to either the ICG fluorescence imaging group or the standard care group. * Undergo postoperative imaging to check the bowel connection, usually around postoperative day 5 and approximately 4 weeks after surgery. * Be monitored for postoperative complications during their hospital stay and for 30 days after surgery. * Attend a follow-up assessment approximately 30 days after surgery.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 610 (estimated)
- First submitted
- 1 May 2026
- Start date
- 15 Nov 2026
- Primary completion date
- 31 Jul 2029
- Lead sponsor
- Basavatarakam Indo American Cancer Hospital & Research Institute
- Diseases
- Colorectal cancer
- NCT number
- NCT07899125
What you commit to
- Study type: Interventional
- Planned participants: 610
- From 15 Nov 2026 to the primary completion date, 31 Jul 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Emergency surgery or palliative procedure.
- Any serious contraindication to minimally invasive surgery.
- Planned open rectal surgery.
- Conversion from minimally invasive surgery to open surgery before randomization.
Other illness
- Known allergy or hypersensitivity to indocyanine green (ICG) or iodine.
- Severe renal or hepatic failure.
- Intraoperative discovery of unresectable disease before randomization.
Other
- Pregnancy or lactation.
- Inability to construct the planned colorectal or coloanal anastomosis before randomization.
Who the study is looking for
- Age 18 to 75 years, inclusive.
- Histologically confirmed rectal adenocarcinoma, treated with or without neoadjuvant therapy.
- Planned minimally invasive anterior rectal resection (laparoscopic or robotic) with anastomosis 2-15 cm from the anal verge, below the peritoneal reflection.
- Planned colorectal or coloanal anastomosis.
- Ability to provide written informed consent.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Basavatarakam Indo American Cancer Hospital and Research Institute Coordinator of this site? Confirm its status | Hyderabad | India | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.