IntAct- IFA to prevent anastomotic leak in rectal cancer surgery

Not Applicable

• Conditions: Colorectal cancer; Cancer

• Registration Number: ISRCTN13334746
• Lead Sponsor: niversity of Leeds

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-05-02
• Last Update Posted: 5 June 2023
• Study Completion: 2023-11-30

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 880

Inclusion Criteria

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

Exclusion Criteria

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
10. Pregnant or likely to become pregnant within 3 months of surgery
11. Immunocompromised patients e.g. taking steroids or receiving immunotherapy

Previous participant 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 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 drugs known to interact with ICG e.g. anticonvulsants, bisulphite containing drugs, methadone, nitrofuratoin
10. Use of oral antibiotics within 8 weeks prior to randomisation
11. Pregnant or likely to become pregnant within 3 months of surgery

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical anastomotic leak rate is defined as per the International Study Group of Rectal Cancer definition, as a confirmed defect of the intestinal wall at the anastomotic site (including suture and staple lines of neorectal reservoirs) leading to a communication between the intra- and extraluminal compartments that has an impact on patient management, as assessed through clinical examination within 90 days post operation