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Clinical Trial 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).


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04688242
Study type Interventional
Source Sixth Affiliated Hospital, Sun Yat-sen University
Contact Ruoxu Dou, M.D.
Phone +86-756-2528708
Email dourx@mail.sysu.edu.cn
Status Recruiting
Phase Phase 2
Start date February 20, 2021
Completion date December 31, 2023

See also
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