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Botulinum Toxin Injection Versus Anal Myectomy in Management of Idiopathic Constipation

NCT02361749 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2018-01-30

No results posted yet for this study

Summary

Chronic idiopathic constipation is most common cause of Constipation in childhood with numerous cases in Egypt. Numerous conservative measures were tried but many fail. Surgical options include Longitudinal Myectomy of the muscle or injection of Botulinum toxin. Objectives: Comparative study between Botulinum toxin injection and Myectomy in treatment of Idiopathic Constipation

Conditions

  • Chronic Idiopathic Constipation
  • Functional Constipation

Interventions

DRUG

Botulinum Toxin

Injection of Botulinum toxin under general anesthesia. Four injections will be given into the anal sphincter into the four quadrants in one session.

PROCEDURE

Anal Myectomy

Longitudinal anal myectomy will be performed under general anesthesia as a day case.

Sponsors & Collaborators

  • Cairo University

    lead OTHER

Principal Investigators

  • Mohamed Seoudi · Cairo University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
2 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-09-30
Primary Completion
2018-08-31
Completion
2018-12-31

Countries

  • Egypt

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 NCT02361749 on ClinicalTrials.gov