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Clinical Trials/EUCTR2021-000593-29-FR
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:
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Conditions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Active, not recruiting
Sponsor
Enrollment
20
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

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

Sponsor
CHU DE BORDEAUX

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