Colonic Intramural Injections of Botulin toxin versus placebo to treat fragmented defecation and urgency after restorative total mesorectal excision (TME) for rectal cancer
Key facts
- Where
- Leuven, BelgiumSee the site
- Phase
- 2. fázis
Where in Belgium
- UZ LeuvenLeuven, BelgiumToborzás még nem indult
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- UZ Leuven
- Trial code
- EU 2025-524342-96-00
- Record updated
- 2026. április 2.
- Original description
LARS is a common and debilitating complication following restorative TME, affecting up to 75% of patients in the early postoperative period. Abnormal motor patterns due to autonomic denervation contribute significantly. Botulinum toxin A reduces smooth muscle contraction by blocking acetylcholine release and has shown benefit in urge fecal incontinence. This study explores whether intramural BoNTA injections can attenuate abnormal colonic motility and improve symptoms. Main objective: To assess the difference in LARS score between BoNTA- and placebo-treated groups at 3 months post-surgery.Read full original descriptionShow less
LARS is a common and debilitating complication following restorative TME, affecting up to 75% of patients in the early postoperative period. Abnormal motor patterns due to autonomic denervation contribute significantly. Botulinum toxin A reduces smooth muscle contraction by blocking acetylcholine release and has shown benefit in urge fecal incontinence. This study explores whether intramural BoNTA injections can attenuate abnormal colonic motility and improve symptoms. Main objective: To assess the difference in LARS score between BoNTA- and placebo-treated groups at 3 months post-surgery.
Inclusion: Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures 2. At least 18 years of age at the time of signing the Informed Consent Form (ICF) 3. Use of highly effective methods of birth control; defined as those that, alone or in combination, result in low failure rate (i.e., less than 1% per year) when used consistently and correctly; such as implants, injectables, combined oral contraceptives, some IUDs, true sexual abstinence (i.e. refraining from heterosexual intercourse during the entire period of risk associated with the Trial treatment(s)) or commitment to a vasectomised partner. 4. Candidates scheduled for elective restorative total mesorectal excision for rectal cancer.
Exclusion: Partial Mesorectal Excision (PME) and local excision 2. Resection beyond TME 3. T4 requiring pelvic exenteration 4. Inflammatory Bowel Disease (IBD) 5. If applicable: Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate, highly effective contraceptive 6. Participation in an interventional Trial with an investigational medicinal product (IMP) or device 7. Temporary or permanent stoma 8. Known hypersensitivity to botulinum toxin type A or to any of its excipients. 9. Presence of infection at the proposed injection site. 10. Known neuromuscular junction disorders such as myasthenia gravis or Lambert-Eaton syndrome.