The Value of Botox-A for Management of Low Anterior Resection Syndrome

Last updated: February 9, 2018
Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
Overall Status: Completed

Phase

2

Condition

Rectal Cancer

Colon Cancer

Colorectal Cancer

Treatment

N/A

Clinical Study ID

NCT01589471
CE 11.088
  • Ages 18-80
  • All Genders

Study Summary

Low anterior resection syndrome (LARS) is frequent after treatment for low rectal cancer. Increased bowel frequency and urgency with rectal spasms and incontinence have deleterious impacts on quality of life in a third of the cases.

One possible physiopathology hypothesis suggests an ongoing spastic process; different mechanisms have been postulated. These include alteration of normal anorectal sensation with loss of the recto-anal inhibitory reflex (RAIR), decreased rectal compliance and reduced rectal capacity as well as sphincter damage secondary to preoperative chemoradiation therapy or during surgery.

Current available treatments are often ineffective, highlighting the need for more successful management. Botulinum toxin A (BTX-A) is a neurotoxin inhibiting acetylcholine release at the neuromuscular junction. It is currently used for the treatment of various smooth muscle spastic diseases.

The hypothesis of this study is that intra-rectal BTX-A injections could represent a medical treatment alternative for LARS. The goal of this study is to document the effects of intra-rectal BTX-A injections on sphincter function and quality of life of patients with LARS.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age 18 years or older

  • Aptitude to sign informed consent

  • Diagnosis of low anterior resection syndrome (LARS) : More than 12 months aftersphincter-preserving surgery for treatment of locally advanced rectal cancer, Mild tomoderate underwear soiling, Baseline Wexner score ranging from 0-16 (moderatesymptoms, and Patient-reported imperious defecation or Patient-reported incompletestool evacuation

  • Digital rectal exam (by surgeon) demonstrating satisfying anorectal tonus consideringprior radical rectal surgery.

  • Willingness to complete questionnaires and manometric studies before and after Botox-Aadministration

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

Exclusion

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, Myastheniagravis, Eaton-Lambert syndrome, lateral amyotrophic sclerosis or any otherneurological 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 ( acetylsalicylic acid) allowed

Study Design

Total Participants: 23
Study Start date:
May 01, 2012
Estimated Completion Date:
November 30, 2015

Study Description

No more information desired

Connect with a study center

  • Centre Hospitalier Universitaire de Montréal

    Montreal, Quebec H2X 3J4
    Canada

    Site Not Available

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