Pathway of Low Anterior Resection Syndrome Relief After Surgery: a Feasibility Study

NCT05319054 | Unknown

• 2 other identifiers: 8238307764
• Study Type: interventional
• Target: 187
• Locations: 1 country
• Sites: 4

Brief Summary

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

Low Anterior Resection Syndrome

Keywords

Sacral Neuromodulation; Transanal Irrigation; Trials within cohorts; Colorectal cancer; Quality of Life

Outcome Measures

Primary Outcomes (10)

• Recruitment rate of to cohort arm of study

  The total number of participants enrolled into the study over the recruitment period.

  9 months

• Assess characteristics of patients recruited to the cohort

  We will record basic demographics, medical history and prevalence of relative symptoms of participants enrolled in the cohort study to describe the characteristics of no- minor- and major- LARS patients

  9 months

• Prevalence of 'major LARS' in the patient cohort

  The number of participants in the cohort that meet the criteria for 'major low anterior resection syndrome (LARS)', as measured by the LARS scoring tool. LARS scoring tool produces a score from 0 - 42, which represents the severity of symptoms, where 0 is least severe and 42 is most severe. Score =\>30 is considered 'major LARS'. LARS score will be measured at 5 times at 3-monthly intervals over 12 months.

  12 months

• Onset of 'major LARS' symptoms in relation to surgery

  The time (in months) from resection surgery to onset of 'major LARS' symptoms, as reported by the LARS scoring tool.

  Time from surgery to onset of major LARS, up to 10 years.

• Onset of 'major LARS' symptoms in relation to radiotherapy treatment

  The time (in months) from completing radiotherapy treatment to onset of 'major LARS' symptoms, as reported by the LARS scoring tool.

  Time from ending radiotherapy treatment to onset of major LARS, up to 10 years.

• Recruitment rate to randomised trial part of the study

  The total number of cohort participants that are enrolled into the randomised trial part of the study, over the recruitment period.

  9 months

• Proportion of randomised participants that are allocated to each trial arm

  The proportion of randomised participants that meet the criteria for, and are allocated to, each of the three trial arms (transanal irrigation; sacral neuromodulation; optimised conservative management).

  9 months

• Describe variation in clinical practice across UK sites

  Where possible, we will record patient's previous treatments and interactions with health services in relation to their bowel dysfunction symptoms. This will be used to describe the variation in UK clinical practice in terms of diagnosis, management and treatment pathways.

  Up to 10 years prior to recruitment

• Compliance of participants to the study programme

  The proportion of participants that complete and return follow-up questionnaires (four questionnaires at 3-month intervals).

  12 months

• Adherence of participants to the treatment programme

  The proportion of patients that continue to receive the treatment assigned to them at the end of the follow-up period.

  12 months

Secondary Outcomes (7)

• Change in LARS score

  12 months.

• Change in EuroQuol 5-Dimension Health-related Quality of Life instrument (5-level) (EQ-5D-5L)

  12 months

• Change in European Organisation for Research and Treatment of Cancer Colorectal Quality of Life Questionnaire

  12 months

• Change in European Organisation for Research and Treatment of Cancer Cancer Quality of Life Questionnaire

  12 months

• Change in medical outcome profile score

  12 months

Study Arms (4)

Cohort

NO INTERVENTION

Patients who have undergone colonic resection for colorectal cancer in the last 10 years. Patient reported outcome measures collected at 3-monthly intervals.

Optimised Conservative Management

ACTIVE COMPARATOR

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.

Other: Optimised Conservative Management

Trans-Anal Irrigation

ACTIVE COMPARATOR

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.

Device: Trans-Anal Irrigation; Other: Optimised Conservative Management

Sacral NeuroModulation

ACTIVE COMPARATOR

Cohort participants who are identified as having 'major LARS' at any point are treated with Sacral Neuromodulation system, in addition to receiving optimised conservative management. Medtronic Interstim system will be used.

Device: Sacral NeuroModulation; Other: Optimised Conservative Management

Interventions

Sacral NeuroModulation DEVICE

Sacral Neuromodulation group will include up-to 20 patients with major LARS. Medtronic Interstim system will be used, including 2 week trial device.

Sacral NeuroModulation

Trans-Anal Irrigation DEVICE

Trans-Anal irrigation group will include up-to 20 patients with major LARS. Specific system will be agreed with the patient, depending on eligibility and preference.

Trans-Anal Irrigation

Optimised Conservative Management OTHER

Optimised conservative management will include up-to 30 patients with major LARS. They will be provided with a resource booklet which includes dietary and lifestyle advice as well as exercises that can be undertaken independently.

Optimised Conservative Management; Sacral NeuroModulation; Trans-Anal Irrigation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cardiff and Vale University Health Board: lead
• University of Leeds: collaborator
• Aneurin Bevan University Health Board: collaborator
• University Hospital Southampton NHS Foundation Trust: collaborator
• Bowel Research UK: collaborator
• The Leeds Teaching Hospitals NHS Trust: collaborator

Study Sites (4)

University Hospital Southampton NHS Foundation Trust

Southampton, Hampshire, SO16 6YD, United Kingdom

Location

Leeds Teaching Hospital NHS Trust

Leeds, Yorkshire, LS9 7TF, United Kingdom

Location

Julie Cornish

Cardiff, CF14 4XW, United Kingdom

Location

Royal Gwent Hospital

Newport, NP20 2UB, United Kingdom

Location

MeSH Terms

Conditions

Low Anterior Resection Syndrome; Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Rectal Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms

Study Officials

• Julie A Cornish

  Cardiff and Vale University Health Board

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Trials within Cohorts

Study Record Dates

• First Submitted: April 1, 2022
• First Posted: April 8, 2022
• Study Start: May 23, 2022
• Primary Completion: September 30, 2023
• Study Completion: September 30, 2023
• Last Updated: July 20, 2023

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (4)