IntAct: Intraoperative Fluorescence Angiography to Prevent Anastomotic Leak in Rectal Cancer Surgery

niversity of Leeds0 sites880 target enrollmentMay 2, 2017

Overview

No summary available.

Registry

who.int

Start Date

May 2, 2017

End Date

November 30, 2023

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

niversity of Leeds

•1\. Aged 18 years and over
•2\. Able to provide written informed consent.
•3\. Diagnosis of rectal cancer (defined as a lower margin up to 15cm from the anal verge as assessed by endoscopic or radiological assessment)
•4\. Suitable for curative resection by high or low anterior resection
•5\. Suitable for elective laparoscopic or robotic surgery
•6\. ASA less than or equal to 3
•7\. Able and willing to comply with the terms of the protocol including QoL questionnaires

•Current participant exclusion criteria as of 19/02/2021:
•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 Model for End\-Stage Liver Disease (MELD) Score \> 10
•8\. Renal dysfunction, defined as eGFR \< 40mmol/l
•9\. Known allergy to ICG, iodine, iodine dyes, or taking drugs known to interact with ICG e.g. anticonvulsants, bisulphite containing drugs, methadone, nitrofuratoin