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 resectio

Phase 1

• Conditions: ow Anterior Resection syndrome (LARS>20) and refractory medical treatment after rectal resection; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2021-000593-29-FR
• Lead Sponsor: CHU DE BORDEAUX

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-03-03
• Last Update Posted: 3 June 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the efficacy of BOTOX-A on the proportion of patients with bowel dysfunction (LARS score > 20) at 3 months after injection;Secondary Objective: To evaluate<br>- Compliance and Tolerance to treatment at 3 months<br>- Functional outcome (LARS) at 0,1, 2, 3 and 6 months after injection<br>- Faecal incontinence (WEXNER) at 0,1, 2, 3 and 6 months<br>- Quality of life (QLQ-C30 and QLQ-CR29) at 0, 1, 3 and 6 months<br>- Trait anxiety (STAI-Y trait) at baseline<br>- State anxiety (STAI-Y state) at baseline, 1,3 and 6 months<br>- Anorectal Ultrasound at baseline<br>- Manometry at 0,1,3 and 6 months<br>- Rectal compliance (Barostat) at 0,1,3 and 6 months<br>- Efficacy of BOTOX-A at 6 months<br>- Correlation between LARS and physiologic tests will be analyzed at 0, 1, 3 and 6 months<br>;Primary end point(s): Proportion of patients with LARS > 20 at 3 months after injection;Timepoint(s) of evaluation of this end point: At 3 months after injection