How many people suffer from bowel problems following surgery for colorectal cancer, and what treatments are the best for managing these problems?

Not Applicable

• Conditions: ow anterior resection syndrome; Digestive System

• Registration Number: ISRCTN12834598
• Lead Sponsor: Cardiff and Vale University Health Board

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-08-04
• Last Update Posted: 21 August 2023
• Study Completion: 2028-03-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 800

Inclusion Criteria

General inclusion criteria (cohort):
1. Diagnosis of rectal or sigmoid cancer
2. Low or high anterior resection (colorectal resection with anastomosis to the rectum)
3. Functioning anastomosis
4. Primary surgery less than 10 years before recruitment
5. At least 6 months since reversal of stoma or primary surgery if no stoma created
6. Aged = 18 years old
7. Able to provide written informed consent

RCT inclusion criteria - as above plus:
8. Major LARS symptoms within the last 3 months (Defined as a LARS score of =30)
9. Clinically appropriate for randomisation as determined by the treating clinician

Exclusion Criteria

Cohort exclusion criteria:
1. Receiving ongoing chemotherapy, radiotherapy or immunotherapy treatment for cancer
2. Anterior exenteration

RCT
3. Receiving ongoing chemotherapy, radiotherapy or immunotherapy treatment for cancer
4. Metastatic disease
5. Inflammatory bowel disease
6. Pregnancy
7. Use of TAI for LARS within 1 month prior to randomisation
8. Not eligible for SNM and not eligible for TAI
9. Anterior exenteration
10. Anastomotic stricture
11. History of anastomotic leak with evidence of ongoing leak/sinus

Plus treatment-specific exclusions:
Exclusion criteria for SNM:
12. Site unable to offer SNM as a treatment
13. Previous SNM
14. Specific contraindications to implantation
15. Any other contraindications advised by the care team, product manufacturer or distributor

Exclusion criteria for TAI:
16. Unable to perform TAI
17. History of anastomotic leak with evidence of ongoing leak/sinus
18. Previous or current use of TAI for LARS
19. Site unable to offer TAI as a treatment
20. Any other contraindications advised by the care team, product manufacturer or distributor

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
ARS score measured using the LARS score questionnaire at baseline and every 3 months until 24 months post registration/randomisation

Secondary Outcome Measures

Name	Time	Method
RCT and cohort study:<br>1. Health-related quality of life and physical, psychological and emotional functioning, is measured using the EORTC QLQ C30, EORTC CR29 and the LARS iCAT questionnaire at baseline and at 3, 6, 12 and 24 months after registration/randomisation<br>2. Incidence of adverse events related to the trial/trial procedures within 24 months of registration/randomisation, categorised using the CTCAE Grading (plus Clavien-Dindo or ClassIntra classification for adverse events relating to surgery) using medical notes<br><br>Secondary outcome measures (RCT only)<br>1. Generic quality of life measured using EQ-5D-5L, at baseline 3, 6, 12 and 24 months after randomisation<br>2. Treatment compliance will be measured using medical records <br>3. Cost-effectiveness will be measured using a health resource use questionnaire at baseline, 3, 6, 12 and 24 months after randomisation and medical records