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The Value of Botox-A Administered as a Single Intra-rectal Injection for the Management of Low Anterior Resection Syndrome: A Phase II Study


Phase 2
18 Years
80 Years
Open (Enrolling)
Both
Low Anterior Resection Syndrome, Rectal Cancer

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Trial Information

The Value of Botox-A Administered as a Single Intra-rectal Injection for the Management of Low Anterior Resection Syndrome: A Phase II Study


Inclusion Criteria:



- Age 18 years or older

- Aptitude to sign informed consent

- Diagnosis of low anterior resection syndrome (LARS) : More than 12 months after
sphincter-preserving surgery for treatment of locally advanced rectal cancer, Mild to
moderate underwear soiling, Baseline Wexner score ranging from 7-16 (moderate
symptoms, and Patient-reported imperious defecation or Patient-reported incomplete
stool evacuation

- Digital rectal exam (by surgeon) demonstrating satisfying anorectal tonus considering
prior radical rectal surgery.

- Willingness to complete questionnaires and manometric studies before and after
Botox-A administration

- Prior failed medical treatment, at least one attempt (narcotics, loperamide,
cholestyramine, fibers)

Exclusion Criteria:

- Inability to sign informed consent

- Counter-indication to Botox-A administration : Allergy to Botox-A or its ingredients
(Clostridium botulinum type A neurotoxin complex, human albumin and sodium chloride,
Allergy to other forms of botulinum toxin (Dysport, Xeomin or Myobloc, Myasthenia
gravis, Eaton-Lambert syndrome, lateral amyotrophic sclerosis or any other
neurological disease which might interfere with neuromuscular function

- Prior use of any form of botulinum toxin A, for any indication

- Infection at proposed Botox-A injection site

- Personal or family history of bleeding diathesis

- Pregnancy or breastfeeding

- Severe incontinence (Wexner score ≥ 17 or daily use of diapers)

- Patient taking anticoagulant. ASA allowed

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Efficacy of intra-rectal Botox-A injection on anorectal function as documented with standardized Wexner score

Outcome Time Frame:

1 month

Safety Issue:

Yes

Principal Investigator

Carole S Richard, MD FCRSC

Investigator Role:

Principal Investigator

Investigator Affiliation:

Centre hospitalier de l'Université de Montréal (CHUM)

Authority:

Canada: Health Canada

Study ID:

CE 11.088

NCT ID:

NCT01589471

Start Date:

May 2012

Completion Date:

August 2013

Related Keywords:

  • Low Anterior Resection Syndrome
  • Rectal Cancer
  • Low anterior resection syndrome
  • Botulinum toxin A
  • Quality of life
  • Incontinence
  • Rectal cancer
  • Anorectal manometry
  • Rectal Neoplasms

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