Anastomotic leak
Conditions
Interventions
Surgery will be performed according to the surgeon’s usual technique. At the end of the procedure all participants will have a rectal catheter placed by the operating surgeon.
• Tranexamic Acid Group:
Sponsors
University of Leeds
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: Current key inclusion criteria as of 23/01/2026: 1. Aged greater than or equal to 18 years 2. Able to provide written informed consent 3. Biopsy proven adenocarcinoma of the rectum or sigmoid colon or high-grade dysplasia with endoscopic/radiological evidence suggestive of cancer. 4. The responsible surgeon has determined the patient suitable for curative resection through either high or low anterior resection 5. The responsible surgeon has deemed the patient appropriate for elective open, laparoscopic or robotic surgery. 7. American Society of Anesthesiologists grade (ASA) less than or equal to 3 8. Able and willing to comply with the terms of the Protocol, including those related to pregnancy/ contraception _____ Previous key inclusion criteria: 1. Aged greater than or equal to 18 years 2. Able to provide written informed consent 3. Biopsy proven adenocarcinoma of the rectum or sigmoid colon 4. The responsible surgeon has determined the patient suitable for curative resection through either high or low anterior resection 5. The responsible surgeon has deemed the patient appropriate for elective open, laparoscopic or robotic surgery. 6. The responsible surgeon has deemed the planned level of distal bowel transection, and thus the level of the colorectal/anal anastomosis, to be =15cm from the anal verge 7. American Society of Anesthesiologists grade (ASA) less than or equal to 3 8. Able and willing to comply with the terms of the Protocol, including those related to pregnancy/ contraception
Exclusion criteria
Exclusion criteria: Current key exclusion criteria as of 23/01/2026: 1. Patients not undergoing colo-rectal/anal anastomosis e.g., abdominoperineal excision of rectum (APER), Hartmann’s procedure 2. Patients with coexistent colorectal pathology e.g., inflammatory bowel disease 3. Patients for whom the responsible surgeon considers there is a clear contraindication for tranexamic acid e.g. known allergy to tranexamic acid, a prior history of acute venous or arterial thrombosis, a medical history of seizures or convulsions, a medical history of disseminated intravascular coagulation, a medical history of severe renal impairment. 4. Patients who are breastfeeding, pregnant or likely to become pregnant within 3 months of surgery _____ Previous key exclusion criteria: 1. Patients not undergoing colo-rectal/anal anastomosis e.g., abdominoperineal excision of rectum (APER), Hartmann’s procedure 2. Patients with coexistent colorectal pathology e.g., inflammatory bowel disease 3. Patients for whom the responsible surgeon considers there is a clear contraindication for tranexamic acid e.g. known allergy to tranexamic acid, a prior history of acute venous or arterial thrombosis, a medical history of seizures or convulsions, a medical history of disseminated intravascular coagulation, a medical history of diseases of the retina, a medical history of severe renal impairment. 4. Patients who are breastfeeding, pregnant or likely to become pregnant within 3 months of surgery 5. Concurrent enrolment in another CTIMP 6. Concomitant administration of tranexamic acid for any other indication (tranexamic acid is not part of routine surgical care at LTHT)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Measured at the end of the study: Outcomes to inform progression: 1. Number of eligible patients recruited. 2. Average compliance to the study treatment schedule. 3. Proportion of missing clinical outcome data. 4. Incidence of serious and unexpected serious complications. Outcomes to explore clinical variability: 1. Anastomotic leak defined and graded using the International Study Group definition. 2. Post-operative complications measured using the Clavien-Dindo scale. | — |
Secondary
| Measure | Time frame |
|---|---|
| Exploratory outcomes for the two sub-studies: Microbiome sub-study: 1. Bacterial 16S rRNA analysis to determine microbiome populations at the following time-points: i) pre-operative, ii) intra-operative, iii) on post-operative day 3-5. 2. Bacterial collagenase assay to quantify collagenase levels at the following time-points: i) pre-operative, ii) intra-operative, iii) on post-operative day 3-5. Qualitative sub-study: 1. Patient and healthcare worker experiences of the intervention and the intervention schedule. 2. Enablers and barriers affecting compliance to the intervention. Individual qualitative interviews will take place after treatment has been completed | — |
Countries
England, United Kingdom
Outcome results
None listed