Colonic Intramural Injections of Botulin toxin versus placebo to treat fragmented defecation and urgency after restorative total mesorectal excision (TME) for rectal cancer

Overview

Sponsor-declared trial summary

Key facts

Sponsor

UZ Leuven

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Digestive System Diseases [C06], Diseases [C] - Neoplasms [C04]

Decision date (initial)

2026-04-02

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Prophylaxis, Therapy

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.

Conditions and MedDRA coding

Rectal Cancer

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

1. 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.

Exclusion criteria 1

1. 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.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Primary endpoint: Difference in LARS score between BoNTA and placebo groups at 3 months.

Secondary endpoints 1

1. - Secondary endpoints: Clinical assessments at 1, 3, and 6 months; patient-reported outcomes (LARS, Wexner, EORTC QLQ-C30 and QLQ-CR29); episodes of urgency/fragmented defecation; colonic manometry parameters; adverse events.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

UZ Leuven

Sponsor organisation

UZ Leuven

Address

Herestraat 49

City

Leuven

Postcode

3000

Country

Belgium

Scientific contact point

Organisation

UZ Leuven

Contact name

Cédric Schraepen

Public contact point

Organisation

UZ Leuven

Contact name

Cédric Schraepen

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 16 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications