ISRCTN10442425进行中（未招募）未知
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
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 入组人数
- 200
研究概览
简要总结
2023 Protocol article in http://dx.doi.org/10.1136/bmjopen-2022-064248 (added 07/03/2023)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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.
研究者
相似试验
已完成
不适用
Does a 10-week physiotherapy programme, using interactive exercise equipment, improve balance and walking in children with cerebral palsy aged 4-18 years when compared to usual care?Ambulant children with cerebral palsy GMFCS I-IIINervous System DiseasesCerebral palsyISRCTN80878394Plymouth University16
进行中（未招募）
不适用
A study to evaluate operation of flexor tendon injury under local anaesthesia compared to general or regional anaesthesiaISRCTN15052559Royal Free London NHS Foundation Trust60
进行中（未招募）
不适用
Can we do a study to prevent cognitive decline with hearing aids?Cognitive declineMental and Behavioural DisordersISRCTN84550071niversity Medical Center Utrecht24
已完成
不适用
The impact of pausing BTKi therapy and responsiveness of vaccination in blood cancer patients: A randomised controlled study – the IMPROVE studyChronic lymphocytic leukaemiaCancerISRCTN14197181niversity of Birmingham99
已完成
不适用
A trial of acceptance and commitment therapy for people with motor neuron diseaseMotor neuron diseaseNervous System DiseasesISRCTN12655391niversity College London Hospitals NHS Foundation Trust206