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

NCT04688242 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 164

Last updated 2022-12-06

No results posted yet for this study

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).

Conditions

  • Low Anterior Resection Syndrome

Interventions

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

Sponsors & Collaborators

  • Fifth Affiliated Hospital, Sun Yat-Sen University

    collaborator OTHER

  • Sixth Affiliated Hospital, Sun Yat-sen University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-20
Primary Completion
2023-12-31
Completion
2023-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04688242 on ClinicalTrials.gov