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NCT07899125
FLuorescent Angiography in REduction of Anastomotic Leak in Rectal Cancer Surgery
Conditions: Rectal Cancer Patients, Rectal Cancer Surgery, Colorectal Cancer, Anastomotic Leak Rectum, Anastomotic Leakage in Colon Surgery
Sex: All
Ages: 18 Years – 75 Years
Healthy volunteers: No
Phase: NA
Enrollment: 610
Sponsor: Basavatarakam Indo American Cancer Hospital & Research Institute
Location: Basavatarakam Indo American Cancer Hospital and Research Institute Hyderabad Telangana
Summary
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.
Eligibility Criteria
Inclusion Criteria:
* 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.
Exclusion Criteria:
* Emergency surgery or palliative procedure.
* Known allergy or hypersensitivity to indocyanine green (ICG) or iodine.
* Pregnancy or lactation.
* Severe renal or hepatic failure.
* Any serious contraindication to minimally invasive surgery.
* Planned open rectal surgery.
* Conversion from minimally invasive surgery to open surgery before randomization.
* Intraoperative discovery of unresectable disease before randomization.
* Inability to construct the planned colorectal or coloanal anastomosis before randomization.
Source: ClinicalTrials.gov (NCT07899125). StuddyBuddy aggregates publicly available trial information.