Pathway of low anterior resection syndrome relief after surgery (POLARiS) trial

Cardiff and Vale University Health Board0 个研究点目标入组 800 人开始时间: 2023年8月4日最近更新: 2023年8月21日

适应症

试验速览

暂无简介。

•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

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

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