The Value of Botox-A for Management of Low Anterior Resection Syndrome
Recruitment status was: Active, not recruiting
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.
|Low Anterior Resection Syndrome Rectal Cancer||Drug: intra-rectal Botulinum toxin A injection||Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official 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|
- Efficacy of intra-rectal Botox-A injection on anorectal function as documented with standardized Wexner score [ Time Frame: 1 month ]
- Efficacy of intra-rectal Botox-A injection on anorectal function as documented with standardized Wexner score [ Time Frame: 3 months ]
- 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 ]
- 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
- 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
- Efficacy of intra-rectal Botox-A injection on anorectal function as documented with standardized anorectal manometry readings [ Time Frame: 1 month ]
- 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 ]
- Safety of intra-rectal Botox-A injections as documented with adverse events monitoring [ Time Frame: 1 month, 3 months and 6 months ]
|Study Start Date:||May 2012|
|Estimated Study Completion Date:||November 2015|
|Estimated Primary Completion Date:||October 2015 (Final data collection date for primary outcome measure)|
Intra-rectal (or intra-colic) injection of 100 U of Botox-A
Drug: intra-rectal Botulinum toxin A injection
intra-colic injection of 100 U of Botulinum toxin A as a single injection distributed amongst the four quadrants, 5 cm above anastomosis
Other Name: Botox (Allergan)
Please refer to this study by its ClinicalTrials.gov identifier: NCT01589471
|Centre Hospitalier Universitaire de Montréal|
|Montreal, Quebec, Canada, H2X 3J4|
|Principal Investigator:||Carole S Richard, MD FCRSC||Centre hospitalier de l'Université de Montréal (CHUM)|