Intraoperative Fluorescence Angiography to Prevent Anastomotic Leak in Rectal Cancer Surgery

Recruiting

• Conditions: anastomotic failure; dehiscence; 10017998

• Registration Number: NL-OMON55573
• Lead Sponsor: St James's University Hospital of Leeds, United Kingdom

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 30

Inclusion Criteria

aged * 18 years with a diagnosis of rectal cancer,
suitable for curative resection by high or low anterior resection
(laparoscopic or robotic) with anastomosis.

Exclusion Criteria

1. Patients not undergoing colo-rectal/anal anastomosis e.g. abdominoperineal
excision of
rectum (APER), Hartmann*s procedure.
2. Patients undergoing synchronous colonic resections.
3. Locally advanced rectal cancer requiring extended or multi-visceral excision.
4. Recurrent rectal cancer
5. Coexistent colorectal pathology e.g. synchronous cancers, inflammatory bowel
disease.
6. Previous pelvic radiotherapy for pathology unrelated to diagnosis with
rectal cancer e.g.
treatment for prostate cancer
7. Hepatic dysfunction, defined as bilirubin outside of institutional limits
and/or ALT/AST >2.5
x institutional upper limit of normal.
8. Renal dysfunction, defined as eGFR <40 mL/min/1.73m2 (or a serum creatinine
value4
>10% of upper value for normal institutional limits if eGFR is not performed
locally)
9. Known allergy to ICG, iodine, iodine dyes, or drugs known to interact with
ICG e.g.
anticonvulsants, bisulphite containing drugs, methadone, nitrofuratoin.
10. Pregnant or likely to become pregnant within 3 months of surgery5

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary endpoint:<br /><br>* Clinical anastomotic leak rate within 90 days post-operation</p><br>