Clinical trial · Interventional
Pathway of Low Anterior Resection Syndrome Relief After Surgery: a Feasibility Study
A Feasibility, Multicentre Randomised Control Trial Assessing the Treatment Options for Patient With Major Low Anterior Resection Syndrome to Establish a Pathway Of Low Anterior Resection Syndrome Relief After Surgery
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Currently, no standard exists for the treatment and management of Low Anterior Resection Syndrome (LARS)- a common disorder that affects patients who have had part of their bowel removed due to colorectal cancer. Decisions about which treatment patients receive is at the discretion of local clinicians, leading to a variation in both clinical practice and the outcomes of these patients. As a result, there is a need for research to assess what treatments are most effective in treating or managing LARS to establish a consensus and develop a treatment pathway in the UK. This study aims to assess the feasibility of undertaking such a trial utilising a novel 'trial within cohorts (TWiCs)' study design, with a view to informing the design of a full-scale trial.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Low Anterior Resection Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Optimised Conservative Management | Other | — | UNRESOLVED |
| Sacral NeuroModulation | Device | — | UNRESOLVED |
| Trans-Anal Irrigation | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- NO_INTERVENTION
- label
- Cohort
- description
- Patients who have undergone colonic resection for colorectal cancer in the last 10 years. Patient reported outcome measures collected at 3-monthly intervals.
- type
- ACTIVE_COMPARATOR
- label
- Optimised Conservative Management
- description
- Cohort participants who are identified as having 'major LARS' at any point are treated with Optimised Conservative Managements, consisting of medication, dietary advice, lifestyle advice and physiotherapy.
- interventionNames
- Other: Optimised Conservative Management
- type
- ACTIVE_COMPARATOR
- label
- Trans-Anal Irrigation
- description
- Cohort participants who are identified as having 'major LARS' at any point are treated with Trans-anal irrigation, in additional to receiving optimised conservative management. Transanal irrigation system will be decided upon with the participant and procured locally.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * For cohort: * Diagnosis of rectal or sigmoid cancer * Low or high anterior resection (colorectal resection with anastomosis to the rectum) * Functioning anastomosis * Aged 18 years and older * Primary surgery/reversal of ileostomy less than 10 years before recruitment * 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 * Willing and able to provide valid informed consent * For randomisation: * Recruited to cohort study * Willing and able to provide valid informed consent for randomisation * Major LARS symptoms (Defined as score of 30+ on LARS scoring tool) * Previous unsuccessful conservative treatment determined by treating clinician and patient Exclusion Criteria: * For cohort \- Inability to understand and complete study questionnaires independently. (Due to cognitive or intellectual impairment, Due to insufficient English language skills) * For randomised control trial * Pregnancy * No previous conservative treatment plan for the management of LARS * Does not meet any treatment-specific criteria * For TAI randomisation: * Unable to perform TAI * History of anastomotic leak with evidence of ongoing leak/sinus * Previous use of TAI for LARS * Site unable to offer TAI as a treatment * Any other contraindications advised by the care team, product manufacturer or distributor * For SNM randomisation: * \<12months since primary cancer surgery * Palliative disease * Site unable to offer SNM as a treatment * Previous SNM * Specific contraindications to implantation * Any other contraindications advised by the care team, product manufacturer or distributor.
References
Publications (0)
Data not yet available