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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

Status
Not yet recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-524342-96-00
Enrollment
20
Registered
2026-04-02
Start date
Unknown
Completion date
Unknown
Last updated
2026-04-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rectal Cancer

Brief summary

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

Detailed description

- 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.

Interventions

DRUGBOTOX 100 Allergan Units Powder for solution for injection
DRUG0.9% sodium chloride solution for injection (NaCl 0.9%).

Sponsors

UZ Leuven
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

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

Secondary

MeasureTime frame
- 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.—

Outcome results

None listed

Source: EU CTIS · Data processed: Apr 3, 2026