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 enrollmentMarch 3, 2021

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: ow Anterior Resection syndrome (LARS>20) and refractory medical treatment after rectal resection
Sponsor: CHU DE BORDEAUX
Enrollment: 20
Status: Active, not recruiting
Last Updated: last year

No summary available.

Registry

who.int

Start Date

March 3, 2021

End Date

TBD

Last Updated

last year

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

CHU DE BORDEAUX

•\- 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:

•\- 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)