FLuorescent Angiography in REduction of Anastomotic Leak in Rectal Cancer Surgery

Condition(s) studied

Investigational drug(s) / intervention(s)

Indocyanine Green Fluorescence Angiography: Indocyanine green will be administered intravenously during surgery. Near-infrared fluorescence imaging will be used to assess bowel blood flow at the planned bowel joining site both for proximal large bowel end and distal rectal stump. The surgeon may change the bowel transection level if fluorescence suggests poor blood flow.

Standard Surgical Perfusion Assessment: Bowel blood flow will be assessed using standard surgical judgment, including bowel color, bleeding from the cut edge, arterial pulsation, and overall tissue appearance.

Study 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

Primary outcome measure(s)

• Total Anastomotic Leakage Rate — Within 30 days after surgery
  Incidence of anastomotic leakage of any grade after surgery. Anastomotic leakage will include grade A, grade B, and grade C leaks. Grade A is a radiological leak without symptoms and without need for active treatment. Grade B is a symptomatic leak requiring non-surgical treatment such as antibiotics or drainage. Grade C is a symptomatic leak requiring reoperation.

Trial sites (1)

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