Colorectal cancer Cancer
Conditions
Interventions
Current interventions as of 19/02/2021:
880 participants will be randomised prior to surgery, on a 1:1 basis, to either surgery with IFA or surgery without IFA using minimisation (incorporating a rand
Sponsors
University of Leeds
Eligibility
Sex/Gender
All
Inclusion criteria
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
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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 19/02/2021: 1. Change in planned anastomosis during surgery, including the decision to undertake a permanent stoma rather than an anastomosis, the site of proximal bowel used for anastomosis, the site of rectal remnant used for anastomosis, and the decision to undertake a diverting stoma 2. Rate of defunctioning stoma (temp or permanent) 3. Operative and post-operative complications (Clavien-Dindo for complication-level classification and Comprehensive Complication Indicator for patient-level classification) within 90 days of operation 4. Length of post-operative hospital stay 5. Low Anterior Resection Syndrome (LARS) score at 30 days and at 90 days post-operation in patients without defunctioning ileostomy 6. Rate of re-interventions within 90 days 7. Quality of life is assessed using the QLQ-C30, QLQ-CR29, and EQ-5D at 30 days and 90 days post-operation 8. Health resource utilisation assessed at 30 days and 90 days post-operation 9. Death within 90 days of operation Mechanistic sub-study: 1. Changes in rectal microbiome and correlation to anastomotic leak Previous secondary outcome measures: 1. Change in planned anastomosis during surgery, including the decision to undertake a permanent stoma rather than an anastomosis, the site of proximal bowel used for anastomosis, the site of rectal remnant used for anastomosis, and the decision to undertake a diverting stoma 2. Rate of defunctioning stoma (temp or permanent) 3. Operative and post-operative complications (Clavien-Dindo for complication-level classification and Comprehensive Complication Indicator for patient-level classification) within 90 days of operation 4. Length of post-operative hospital stay 5. Low Anterior Resection Syndrome (LARS) score at 30 days and at 90 days post-operation in patients without defunctioning ileostomy 6. Rate of re-interventions within 90 days 7. Quality of life is assessed using the QLQ-C30, QLQ-CR29 and EQ-5D at 30 days and 90 days post- | — |
Countries
Belgium, England, Germany, Ireland, Italy, Netherlands, Slovenia, United Kingdom
Contacts
Public ContactJulie Croft
Outcome results
None listed