Feasibility of an enhanced randomised controlled trial design for treatments of bowel dysfunction after rectal cancer

Not Applicable

• Conditions: Treatment of bowel dysfunction symptoms in patients with low anterior resection syndrome; Digestive System

• Registration Number: ISRCTN10442425
• Lead Sponsor: Cardiff and Vale University Health Board

Brief Summary

2023 Protocol article in http://dx.doi.org/10.1136/bmjopen-2022-064248 (added 07/03/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-12-30
• Last Update Posted: 20 March 2023
• Study Completion: 2023-12-01

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Inclusion for Cohort:
1. Diagnosis of rectal or sigmoid cancer
2. Low or high anterior resection (with anastamosis to the rectum)
3. Functioning anatamosis
4. Aged 18 years and older
5. Primary surgery/reversal of ileostomy less than 10 years before recruitment
6. Reversal of ileostomy at least 12 weeks prior to recruitment with at least a further 12 weeks of standard care to manage symptoms following reversal
7. Willing and able to provide valid informed consent

Inclusion for Randomisation:
1. Recruited to cohort study
2. Willing and able to provide valid informed consent for randomisation
3. Major LARS symptoms (Defined as score of 30+ on LARS scoring tool)
4. Previous unsuccessful conservative treatment determined by treating clinician and patient

Exclusion Criteria

Exclusion from cohort:
1. Inability to understand and complete study questionnaires independently (Due to cognitive or intellectual impairment; Due to insufficient English language skills)

Exclusion from randomised control trial:
1. Pregnancy
2. No previous conservative treatment plan for the management of LARS
3. Does not meet any treatment-specific criteria

Exclusion from TAI randomisation:
1. Unable to perform TAI
2. History of anastomotic leak with evidence of ongoing leak/sinus
3. Previous use of TAI for LARS
4. Site unable to offer TAI as a treatment
5 Any other contraindications advised by the care team, product manufacturer or distributor

Exclusion from SNM randomisation:
1. <12months since primary cancer surgery
2. Palliative disease
3. Site unable to offer SNM as a treatment
4. Previous SNM
5. Specific contraindications to implantation
6. Any other contraindications advised by the care team, product manufacturer or distributor.

Study & Design

• Study Type: Interventional
• Study Design: Not specified