Indocyanine Green Fluorescence Angiography in Laparoscopic Sigmoid and Rectal Cancer Surgery

Indocyanine Green Fluorescence Angiography in Laparoscopic Sigmoid and Rectal Cancer Surgery: A Prospective Single-Center Observational Study With a Historical Control Group

Anastomotic leakage remains a major complication after colorectal cancer surgery. Indocyanine green fluorescence angiography (ICG-FA) allows real-time intraoperative assessment of bowel perfusion; however, its clinical impact remains controversial.

This prospective single-center observational study evaluated the association between intraoperative use of ICG-FA and postoperative outcomes in patients undergoing laparoscopic sigmoid or rectal cancer surgery. Outcomes of patients assessed with ICG-FA were compared with those of a historical control cohort treated without fluorescence imaging.

Study Overview

• Status: Completed
• Conditions: Sigmoid Colon Cancer; Colorectal Cancer (CRC); Rectal Cancer Surgery

Detailed Description

This was a prospective, single-center observational cohort study conducted at a tertiary academic surgical center. Adult patients undergoing elective laparoscopic resection for sigmoid or rectal adenocarcinoma were included. In the prospective cohort, indocyanine green fluorescence angiography was used intraoperatively to assess bowel perfusion prior to anastomosis creation. The decision to modify the transection line was left to the operating surgeon based on fluorescence imaging.

Study outcomes in the ICG-FA cohort were compared with a historical control group of patients who underwent similar laparoscopic procedures without fluorescence imaging during an earlier period at the same institution. The primary outcome was the incidence of anastomotic leakage within 30 days after surgery, defined according to the International Study Group of Rectal Cancer criteria. Secondary outcomes included anastomotic stricture diagnosed during follow-up, postoperative complications, reoperation rate, length of hospital stay, and 30-day mortality.

All patients were treated according to standard institutional perioperative protocols. Data were collected prospectively for the ICG-FA cohort and retrospectively for the control cohort. The study was approved by the local Research Ethics Board, and all procedures were performed in accordance with the Declaration of Helsinki.

• Study Type: Observational
• Enrollment (Actual): 115

Contacts and Locations

Study Locations

• Poland
  • Kraków
    • Krakow, Kraków, Poland
      • University Hospital in Krakow

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult patients undergoing elective laparoscopic resection for sigmoid or rectal adenocarcinoma at a single tertiary academic center.

Description

Inclusion Criteria:

• Age ≥ 18 years
• Histologically confirmed or clinically suspected sigmoid or rectal adenocarcinoma
• Elective laparoscopic resection with curative intent and planned colorectal/coloanal anastomosis
• Ability to provide informed consent

Exclusion Criteria:

• Pregnancy or breastfeeding
• Known hypersensitivity to indocyanine green or iodine
• Emergency surgery
• Planned end colostomy without anastomosis
• Conversion to open surgery

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
ICG-FA group; Prospective cohort of patients undergoing laparoscopic sigmoid or rectal cancer surgery with intraoperative indocyanine green fluorescence angiography for bowel perfusion assessment.
Control group; Historical control cohort of patients undergoing laparoscopic sigmoid or rectal cancer surgery without fluorescence imaging.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anastomotic Leakage Rate	Incidence of anastomotic leakage defined according to the International Study Group of Rectal Cancer criteria.	Within 30 days after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Postoperative Complications	Postoperative complications assessed according to the Clavien-Dindo classification.	Within 30 days after surgery
Postoperative Anastomotic Stricture	Incidence of anastomotic stricture diagnosed endoscopically or radiologically during postoperative follow-up.	Up to 6 months after surgery
Non-elective Reoperation	Incidence of unplanned reoperations within 30 days following primary surgery.	Within 30 days after surgery
Length of Hospital Stay	Length of postoperative hospital stay measured in days.	Up to 60 days
Hospital Readmission	Incidence of hospital readmission within 30 days after discharge.	Within 30 days after discharge
30-day All-cause Mortality	All-cause mortality occurring within 30 days after surgery.	Within 30 days after surgery

Collaborators and Investigators

• Sponsor: Jagiellonian University

Study record dates

Study Major Dates

• Study Start (Actual): October 9, 2023
• Primary Completion (Actual): February 15, 2025
• Study Completion (Actual): July 15, 2025

Study Registration Dates

• First Submitted: February 12, 2026
• First Submitted That Met QC Criteria: February 18, 2026
• First Posted (Actual): February 20, 2026

Study Record Updates

• Last Update Posted (Actual): February 20, 2026
• Last Update Submitted That Met QC Criteria: February 18, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Indocyanine Green; Anastomotic Leakage; Fluorescence Angiography; Laparoscopic Colorectal Surgery; Anastomotic Stricture
• Additional Relevant MeSH Terms: Postoperative Complications; Pathologic Processes; Neoplasms by Site; Neoplasms; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colonic Diseases; Sigmoid Diseases; Colonic Neoplasms; Pathological Conditions, Signs and Symptoms; Colorectal Neoplasms; Anastomotic Leak; Sigmoid Neoplasms
• Other Study ID Numbers: ICG-FA-CRC-UH-Krakow-2023; 1072.6120.59.2023 (Other Identifier: Research Ethics Board, Jagiellonian University Medical College)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No