Status:
UNKNOWN
Pathway of Low Anterior Resection Syndrome Relief After Surgery: a Feasibility Study
Lead Sponsor:
Cardiff and Vale University Health Board
Collaborating Sponsors:
University of Leeds
Aneurin Bevan University Health Board
Conditions:
Low Anterior Resection Syndrome
Eligibility:
All Genders
18+ years
Phase:
NA
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 colore...
Detailed Description
Rectal cancer (cancer of the lower part of the bowel) is one of the most prevalent forms of cancer, and affects approximately 14,000 people each year in the UK. The treatment for the majority of these...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 23 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2023
Estimated Enrollment :
187 Patients enrolled
Trial Details
Trial ID
NCT05319054
Start Date
May 23 2022
End Date
September 30 2023
Last Update
July 20 2023
Active Locations (4)
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1
University Hospital Southampton NHS Foundation Trust
Southampton, Hampshire, United Kingdom, SO16 6YD
2
Leeds Teaching Hospital NHS Trust
Leeds, Yorkshire, United Kingdom, LS9 7TF
3
Julie Cornish
Cardiff, United Kingdom, CF14 4XW
4
Royal Gwent Hospital
Newport, United Kingdom, NP20 2UB