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| ID | Type | Description | Link |
|---|---|---|---|
| 1072.6120.59.2023 | Other Identifier | Research Ethics Board, Jagiellonian University Medical College |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Adult patients undergoing elective laparoscopic resection for sigmoid or rectal adenocarcinoma at a single tertiary academic center.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital in Krakow | Krakow | Kraków | Poland |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D012811 | Sigmoid Neoplasms |
| D057868 | Anastomotic Leak |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| 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 |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D003110 | Colonic Neoplasms |
| D012810 | Sigmoid Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |