EUCTR2021-000593-29-FR进行中（未招募）1 期
A Prospective Pilot Study to assess the efficacy of BOTOX-A in patients with Low Anterior Resection syndrome (LARS>20) and refractory medical treatment after rectal resection - BOTOX-TME
CHU DE BORDEAUX0 个研究点目标入组 20 人开始时间: 2021年3月3日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Patient: male and female, age =18 years
- •- Tumour: rectal cancer
- •- Surgery: anterior resection (high or low) with colorectal or coloanal anastomosis, or intersphincteric resection, or pull-through
- •- Symptoms: Low Anterior Resection Syndrome (LARS score >20) refractory to medical treatment at 3 months after rectal surgery (or after temporary stoma closed)
- •- Straight or pouch colonic reconstruction
- •- Surgery alone or with neoadjuvant therapy (chemoradiotherapy, short course radiotherapy, induction chemotherapy)
- •- Signed and dated informed consent
- •- Patient affiliated to a social security system or beneficiary of the same Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 5
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 15
排除标准
- •- Anal cancer
- •- Anal surgery in the last 3 months
- •- Acute/painful perianal disease
- •- Without adjuvant treatment
- •- Contraindication for BOTOX-A (known hypersensitivity to botulinum toxin type A or to albumin, infection at the proposed injection site, severe myastenia)
- •- Have received BOTOX-A in perianal region in the previous 3 months
- •- General anesthesia performed less than a month
- •- Impossibility of performing a rectoscopy (eg: anal stenosis)
- •- Recent history (<12 months) of myocardial infarction and / or arrhythmias not reduced by appropriate treatment
- •- Subject with a significant deficit of clinical or subclinical neuromuscular transmission (myasthenia or Lambert-Eaton syndrome) or with peripheral motor neuropathy (such as amyotrophic lateral sclerosis or motor neuropathy)
- •- Treatment that directly or indirectly interferes with neuromuscular transmission (aminoglycosides, curare, anticholinesterase, aminoquinoline, cyclosporine, etc.)
- •- History of neuromuscular disorders
- •- Anal clinical examination suggesting the presence of an anorectal abscess
- •- Pregnant woman or breastfeeding woman
- •- Women of child-bearing potential not using effective contraception (oestrogen-progesteron combined contraceptives or intra uterine device) since at least 7 days and during all the duration of the study
- •- Persons deprived of their liberty or under measure of judicial protection (curatorship or guardianship) or unable to give their consent
- •- Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol or follow-up schedule, as assessed by investigator
研究者
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