CTIS2024-515256-21-00进行中（未招募）1 期
Mechanisms of action on rectal motility of intrarectal botulinum toxin injections in patients with fecal incontinence - MECA-TOX - 2021/0384/HP
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 21
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •Active or predominantly active fecal incontinence with failure of 1st-line conservative treatments (normalization of transit, perineal re-education), Impairment of quality of life at investigator's discretion, Patients at least 18 years of age, Patients who have read and understood the information letter and signed the consent form, Patients affiliated to the French Social Security system, Women of childbearing age using effective contraception (Cf. CTFG) (estro- progestins or intrauterine device or tubal ligation) for at least 1 month and a negative B-HCG urine pregnancy test at inclusion and for the duration of the study., Postmenopausal women: confirmatory diagnosis (non-medically induced amenorrhea for at least 12 months prior to inclusion visit)
排除标准
- •Pregnant women, women in labor, breastfeeding women, or women without proven contraception, Presence of infection at injection site(s), General anesthesia less than one month ago, Association with aminoglycosides and anti-cholinesterase agents (risk of increased toxin effects), History of neurogenic damage such as polyradiculoneuritis, History of dysphagia with esophageal or neurological stasis, swallowing disorders, inhalation pneumonitis, Botulinum toxin injections in the 3 months preceding the study, Clinical anal examination suggestive of anorectal abscess, Recent history (<12 months) of myocardial infarction and/or rhythm disorders not reduced by appropriate treatment, Peripheral motor neuropathies (such as amyotrophic lateral sclerosis or motor neuropathy) and underlying neurological disorders, Current treatment with anticoagulants or anti-aggregants or haemostasis disorders according to recommendations (SFED (Société Française d'endoscopie Digestive)). When patients are on anticoagulant or anti-aggregant therapy, the type of injections to be performed depends on the type of anticoagulation and the patient's thrombo-embolic risk: - Patients on anticoagulant or anti-aggregant therapy with a major thrombo-embolic risk will not be included. - Patients on anticoagulant or anti-aggregant therapy with a moderate or low thrombo-embolic risk may be included. If patients are taking a vitamin K antagonist, treatment will be continued provided that the INR is within the usual range of 2 to 3 (GETED, HAS, 2008). If patients are taking anti-aggregants, these can be continued (SFED, HAS, 2012). If patients are taking new oral anticoagulants, they should take a short break and not take the AOD the evening before or the morning of the injections (GIHP, 2015)., Patient deprived of liberty by administrative or judicial decision, or protected adult (under guardianship or trusteeship), Exclusive passive fecal incontinence, Patient suffering from constipation (Rome IV criteria), Patient with an evolving inflammatory or cancerous digestive pathology, Previous rectal surgery, Person participating in another research protocol or having participated in another research protocol in the 4 weeks preceding the inclusion visit, Hypersensitivity to botulinum toxin or to one of the excipients (human albumin, sodium chloride), Neuromuscular junction pathology (myasthenia, Lambert-Eaton syndrome, etc.)
研究者
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