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NCT Number: NCT01589471

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

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.

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Key information

Conditions

Low Anterior Resection Syndrome Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Rectal Cancer Rectal Diseases Rectal Neoplasms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Centre Hospitalier Universitaire de Montréal

Montreal, Quebec, H2X 3J4, Canada

About this study

No more information desired

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 0-16 (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 ( acetylsalicylic acid) allowed

Treatment and study plan

intra-rectal Botulinum toxin A injection

Drug

intra-colic injection of 100 U of Botulinum toxin A as a single injection distributed amongst the four quadrants, 5 cm above anastomosis

Other names: Botox (Allergan)

Primary outcomes

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

    Time frame: 1 month

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

    Time frame: 3 months

Secondary outcomes

  1. Efficacy of intra-rectal Botox-A injection on anorectal function as documented with a visual scale for tenesmus and completeness of stool evacuation

    Time frame: 1 month and 3 months

  2. Efficacy of intra-rectal Botox-A injection on quality of life as documented with EORTC-QlQ standardized questionnaires

    Time frame: 1 month and 3 months

    EORTC-QIQ is a quality of life questionnaire

  3. Efficacy of intra-rectal Botox-A injection as documented with a patient medicine calender

    Time frame: 1 month

    patient-filled calender for usage of any medication intended for symptomatic treatment of LARS

  4. Efficacy of intra-rectal Botox-A injection on anorectal function as documented with standardized anorectal manometry readings

    Time frame: 1 month

  5. Long term efficacy of intra-rectal Botox-A injection on anorectal function as documented with Wexner score, EORTC-QLQ questionnaire and visual scale

    Time frame: 6 months

  6. Safety of intra-rectal Botox-A injections as documented with adverse events monitoring

    Time frame: 1 month, 3 months and 6 months

Sponsors and collaborators

Lead sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Other

Collaborators

  • Allergan

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
May 2, 2012
Registry last updated
Feb 12, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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