University Hospital in Krakow
Krakow, Kraków, Poland
NCT Number: NCT07423130
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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Notify Me18 year and older
All sexes
Observational
Krakow, Kraków, Poland
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Within 30 days after surgery
Incidence of anastomotic leakage defined according to the International Study Group of Rectal Cancer criteria.
Time frame: Within 30 days after surgery
Postoperative complications assessed according to the Clavien-Dindo classification.
Time frame: Up to 6 months after surgery
Incidence of anastomotic stricture diagnosed endoscopically or radiologically during postoperative follow-up.
Time frame: Within 30 days after surgery
Incidence of unplanned reoperations within 30 days following primary surgery.
Time frame: Up to 60 days
Length of postoperative hospital stay measured in days.
Time frame: Within 30 days after discharge
Incidence of hospital readmission within 30 days after discharge.
Time frame: Within 30 days after surgery
All-cause mortality occurring within 30 days after surgery.
Jagiellonian University
Other
Indocyanine Green Fluorescence Angiography in Laparoscopic Sigmoid and Rectal Cancer Surgery: A Prospective Single-Center Observational Study With a Historical Control Group
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