NCT04688242

Anal Dilatation Plus Probiotics Before Ileostomy Reduction for Low Anterior Resection Syndrome

A Randomized, Phase 2 Study of Anal Dilatation Plus Probiotics Before Ileostomy Reduction for Low Anterior Resection Syndrome After Sphincter-preserving Proctectomy

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 164 (estimated)
• Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This is randomized, phase 2 trial in patients with rectal cancer undergoing sphincter-preserving proctectomy and temporary ileostomy, to explore the effects of anal dilatation plus probiotics administered per anus before ileostomy reduction in relieving postoperative bowel dysfunction known as low anterior resection syndrome (LARS).

Detailed description

Approximately 60-90% of patients undergoing sphincter-sparing proctectomy complain of postoperative bowel dysfunction including incontinence, frequency, clustering, and urgency, collectively known as low anterior resection syndrome (LARS). Literatures and our previous data have demonstrated that diverting ileostomy is an independent risk factor for major LARS. This is a randomized, phase 2 trial in patients with rectal cancer who underwent sphincter-preserving proctectomy and ileostomy. This study will explore the effects of anal dilatation plus probiotics administered per anus in relieving the symptoms of LARS.

Conditions

• Low Anterior Resection Syndrome

Interventions

Type	Name	Description
OTHER	Anal dilatation per anus	Digital anal dilatation through anastomosis, with concomitant administration of probiotics per anus
DRUG	administration of probiotics (Clostridium butyricum TO-A; Bacillus mesentericus TO-A; Streptococcus faecalisT-110) per anus	Digital anal dilatation through anastomosis, with concomitant administration of probiotics per anus

Timeline

• Start date: 2021-02-20
• Primary completion: 2023-12-31
• Completion: 2023-12-31
• First posted: 2020-12-29
• Last updated: 2022-12-06

Locations

2 sites across 1 country: China