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NCT Number: NCT07423130

Indocyanine Green Fluorescence Angiography in Laparoscopic Sigmoid and Rectal Cancer Surgery

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Anastomotic Leakage Rate

    Time frame: Within 30 days after surgery

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

Secondary outcomes

  1. Overall Postoperative Complications

    Time frame: Within 30 days after surgery

    Postoperative complications assessed according to the Clavien-Dindo classification.

  2. Postoperative Anastomotic Stricture

    Time frame: Up to 6 months after surgery

    Incidence of anastomotic stricture diagnosed endoscopically or radiologically during postoperative follow-up.

  3. Non-elective Reoperation

    Time frame: Within 30 days after surgery

    Incidence of unplanned reoperations within 30 days following primary surgery.

  4. Length of Hospital Stay

    Time frame: Up to 60 days

    Length of postoperative hospital stay measured in days.

  5. Hospital Readmission

    Time frame: Within 30 days after discharge

    Incidence of hospital readmission within 30 days after discharge.

  6. 30-day All-cause Mortality

    Time frame: Within 30 days after surgery

    All-cause mortality occurring within 30 days after surgery.

Sponsors and collaborators

Lead sponsor

Jagiellonian University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Feb 20, 2026
Registry last updated
Feb 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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