Indocyanine Green Fluorescence Angiography in Laparoscopic Sigmoid and Rectal Cancer Surgery

NCT07423130 | Completed

• 2 other identifiers: ICG-FA-CRC-UH-Krakow-20231072.6120.59.2023
• Study Type: observational
• Target: 115
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Colorectal Cancer (CRC); Rectal Cancer Surgery; Sigmoid Colon Cancer

Keywords

Indocyanine Green; Fluorescence Angiography; Anastomotic Leakage; Anastomotic Stricture; Laparoscopic Colorectal Surgery

Outcome Measures

Primary Outcomes (1)

• Anastomotic Leakage Rate

  Incidence of anastomotic leakage defined according to the International Study Group of Rectal Cancer criteria.

  Within 30 days after surgery

Secondary Outcomes (6)

• Overall Postoperative Complications

  Within 30 days after surgery

• Postoperative Anastomotic Stricture

  Up to 6 months after surgery

• Non-elective Reoperation

  Within 30 days after surgery

• Length of Hospital Stay

  Up to 60 days

• Hospital Readmission

  Within 30 days after discharge

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Jagiellonian University: lead

Study Sites (1)

University Hospital in Krakow

Krakow, Kraków, Poland

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Sigmoid Neoplasms; Anastomotic Leak

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Colonic Neoplasms; Sigmoid Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 12, 2026
• First Posted: February 20, 2026
• Study Start: October 9, 2023
• Primary Completion: February 15, 2025
• Study Completion: July 15, 2025
• Last Updated: February 20, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)