A Randomized Controlled Trial Evaluating Indocyanine Green Fluorescence Angiography for Reduction of Anastomotic Leak After Minimally Invasive Rectal Cancer Surgery

Fluorescent angiography in reduction of anastomotic leak in rectal cancer surgery - Nil

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/04/109238

Enrollment

610

Registered

2026-04-23

Start date

Unknown

Completion date

Unknown

Last updated

2026-04-27

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

Conditions

Health Condition 1: C20- Malignant neoplasm of rectum

Interventions

Intervention1: ICG-FA Group intraoperative perfusion assessment of colorectal anastomosis using indocyanine green fluorescence angiography: In patients randomized to the ICG group, fluorescence an

Eligibility

Inclusion criteria

Inclusion criteria: Adults aged 18 to 75 years. Histologically confirmed rectal adenocarcinoma treated with or without neoadjuvant therapy. Patients planned for minimally invasive anterior rectal resection (laparoscopic or robotic approach). Planned colorectal or coloanal anastomosis located between 2 cm and 15 cm from the anal verge. Ability and willingness to provide written informed consent.

Exclusion criteria

Exclusion criteria: Emergency surgery or procedures performed with palliative intent. Known allergy or hypersensitivity to indocyanine green or iodine. Pregnant or breastfeeding women. Severe renal failure or severe hepatic failure. Any major contraindication to minimally invasive surgery. Intraoperative discovery of unresectable disease. Absence of planned intestinal anastomosis. Conversion to a procedure in which anastomosis is not performed. Major protocol violation affecting study participation.

Design outcomes

Primary

Measure	Time frame
To determine whether intraoperative ICG fluorescence angiography reduces the incidence of total anastomotic leakage (grade A+B+C) within 30 days after minimally invasive rectal cancer surgery.Timepoint: 30 days postoperatively	—

Secondary

Measure	Time frame
Incidence of clinically significant anastomotic leakage (Grade B + C).Timepoint: 30 days postoperatively;30-day postoperative morbidityTimepoint: 30 days;30-day postoperative mortalityTimepoint: 30 days;Rate of intraoperative modification of the proximal transection (of proximal bowel) line after ICG assessment.Timepoint: baseline (Intraoperatively);Rate of intraoperative modification of the distal transection line (of rectal stump) after ICG assessment.Timepoint: ;Time to fluorescence appearance after ICG injectionTimepoint: Baseline (Intraoperatively);Incidence of overall surgical adverse eventsTimepoint: At 1 week & at 4 weeks	—

Measure

Time frame

Incidence of clinically significant anastomotic leakage (Grade B + C).Timepoint: 30 days postoperatively;30-day postoperative morbidityTimepoint: 30 days;30-day postoperative mortalityTimepoint: 30 days;Rate of intraoperative modification of the proximal transection (of proximal bowel) line after ICG assessment.Timepoint: baseline (Intraoperatively);Rate of intraoperative modification of the distal transection line (of rectal stump) after ICG assessment.Timepoint: ;Time to fluorescence appearance after ICG injectionTimepoint: Baseline (Intraoperatively);Incidence of overall surgical adverse eventsTimepoint: At 1 week & at 4 weeks

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Countries

India

Contacts

Public ContactSyed Nusrath

Basavatarakam Indo American Cancer Hospital and Research Institute

drnusrath@basavatarakam.org04023556655

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: May 1, 2026