EUCTR2021-000593-29-FRActive, not recruitingPhase 1
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 sites20 target enrollmentStarted: March 3, 2021Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 20
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •- 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
Exclusion Criteria
- •- 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
Investigators
Similar Trials
Not yet recruiting
Not Applicable
Estimation of type of hearing loss using a new Forehead knuckle tapping methodCTRI/2021/01/030777Dr Prem Sagar
Active, not recruiting
Phase 1
Study to evaluate the efficacy of OnabotulinumtoxinA in migraineMigraineEUCTR2017-002866-38-ITIRCCS FONDAZIONE ISTITUTO NEUROLOGICO NAZIONALE C. MONDINO42
Not yet recruiting
Unknown
study to test the effect of music on quality of life of cancer patients undergoing chemotherapyCTRI/2023/03/050509Apollo Proton Cancer Centre
Not yet recruiting
Unknown
To Investigate whether resveratrol and copper can reduce the amount of virus load in patients with Chronic Hepatitis B and C virus infectioCTRI/2023/05/053055Tata Memorial Hospital
Completed
Not Applicable
The prospective study to evaluate the efficacy of the combination therapy of inhaled budesonide/formoterol fumarate, clarithromycin, and montelukast in AFO after allogeneic SCTAir flow obstruction after allogeneic SCTJPRN-UMIN000022048Department of Hematology, Chiba University Hospital85
