drugset
drugset / Trial / NCT04991688

A Prospective Pilot Study to Assess the Efficacy of BOTOX-A in Patients With Low Anterior Resection Syndrome (LARS>20) and Refractory Medical Treatment After Rectal Resection

NCT04991688 ↗

Phase 2 Terminated 11 enrolled University Hospital, Bordeaux
NaSingle-groupOpen-labelTreatment

Summary

After rectal resection for cancer (with or without stoma), patients may have digestive sequelae. LARS (Low Anterior Resection Syndrome) includes bowel frequency, stool fragmentation, urgency, and faecal incontinence. The goal of this study is to test intra-rectal BOTOX-A on functional outcomes and quality of life of patients with LARS refractory to medical treatment at 3 months after surgery.

Timeline

Start
2021-09-01
Primary completion
2023-01-07
Completion
2023-03-03

Outcome

Outcome not reported

Stopped: “Organizational difficulties”

Drugs

EvaluationDrugModalityDoseRoute
Subject BOTOX-A Protein / enzyme biologic 200 iu Other

Indications

No indication recorded.