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

NCT04991688 | Terminated Phase 2

• 1 other identifier: CHUBX 2020/64
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

After rectal resection for cancer (with or without stoma), patients may have digestive sequelae. LARS (Low Anterior Resection Syndrome) includes bowel frequency, stool fragmentation, urgency, and faecal incontinence. The goal of this study is to test intra-rectal BOTOX-A on functional outcomes and quality of life of patients with LARS refractory to medical treatment at 3 months after surgery.

Conditions

Low Anterior Resection Syndrome (LARS>20); Refractory Medical Treatment After Rectal Resection

Keywords

Rectal surgery; Low Anterior Resection syndrome; Refractory medical treatment; Fecal incontinence

Outcome Measures

Primary Outcomes (1)

• Proportion of patients with LARS > 20

  At 3 months after injection

Secondary Outcomes (11)

• Compliance to treatment

  At 3 months after injection

• Tolerance to treatment

  At 3 months after injection

• Functional outcome with LARS score

  At 0, 1, 2, 3 and 6 months

• Faecal incontinence with Wexner score

  At 0, 1, 2, 3 and 6 months

• Quality of life (QLQ C-30)

  At 0, 1, 3 and 6 months

Study Arms (1)

BOTOX-A

EXPERIMENTAL

Drug: BOTOX-A

Interventions

BOTOX-A DRUG

10 injections of 20 U of toxin will be made into the rectum 5, 10 and 15 cm above the pectinate line. At each level, 3 injections of 20 U will be performed in the submucosa, circumferentially.The last injection is made 20 cm above the pectinate line. Total does not exceed 200U of Botox-A

BOTOX-A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Anal cancer
• Anal surgery in the last 3 months
• Acute/painful perianal disease
• Ongoing adjuvant treatment
• Contraindication for BOTOX-A (known hypersensitivity to botulinum toxin type A or to albumin, infection at the proposed injection site, severe myasthenia)
• 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 (WOCBP)\* 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

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (1)

CHU Bordeaux

Bordeaux, France

Location

MeSH Terms

Conditions

Low Anterior Resection Syndrome; Fecal Incontinence

Interventions

Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Rectal Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Officials

• Eric RULLIER

  University Hospital, Bordeaux

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2021
• First Posted: August 5, 2021
• Study Start: September 1, 2021
• Primary Completion: January 7, 2023
• Study Completion: March 3, 2023
• Last Updated: October 27, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)