Rectal Cancer Clinical Trial
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
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.
No more information desired ;
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