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Colonic Intramural Injections of Botulin toxin versus placebo to treat fragmented defecation and urgency after restorative total mesorectal excision (TME) for rectal cancer
EU CTIS ID: 2025-524342-96-00
What this study is testing
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.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1. 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.
You likely can't join if
- 1. 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.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.