NCT02361749

Brief 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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Sep 2014

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 9, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 12, 2015

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

January 30, 2018

Status Verified

January 1, 2018

Enrollment Period

3.9 years

First QC Date

January 9, 2015

Last Update Submit

January 27, 2018

Conditions

Chronic Idiopathic ConstipationFunctional Constipation

Outcome Measures

Primary Outcomes (1)

  • Absence of insufficient Rome III Diagnostic criteria (0-1 criterion)

    Rome III Diagnostic criteria for chronic idiopathic constipation include two or more of the following in a child with a developmental age of at least 4 years: 1. Two or fewer defecations in the toilet per week 2. At least one episode of fecal incontinence per week 3. History of retentive posturing or excessive volitional stool retention 4. History of painful or hard bowel movements 5. Presence of a large fecal mass in the rectum 6. History of large diameter stools which may obstruct the toilet Outcome measure for Curing Chronic idiopathic constipation is denoted by absence of insufficient criteria (0-1 criterion) to diagnose Chronic idiopathic constipation after receiving corresponding arm of the study.

    2 years

Secondary Outcomes (1)

  • Decrease in Rome III Diagnostic criteria score

    2 years

Study Arms (2)

Myectomy group

ACTIVE COMPARATOR

Subjects will undergo anal myectomy for their anal sphincter.

Procedure: Anal Myectomy

Botox Group

ACTIVE COMPARATOR

Subjects will undergo Botulinum toxin injection into their anal sphincter.

Drug: Botulinum Toxin

Interventions

Botulinum ToxinDRUG

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

Also known as: Botox
Botox Group
Anal MyectomyPROCEDURE

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

Myectomy group

Eligibility Criteria

Age2 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children with Idiopathic constipation

You may not qualify if:

  • Hirschsprung's disease or Anorectal malformations

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University Pediatric Hospital

Cairo, 11432, Egypt

Location

Related Publications (4)

  • Keshtgar AS, Ward HC, Sanei A, Clayden GS. Botulinum toxin, a new treatment modality for chronic idiopathic constipation in children: long-term follow-up of a double-blind randomized trial. J Pediatr Surg. 2007 Apr;42(4):672-80. doi: 10.1016/j.jpedsurg.2006.12.045.

    PMID: 17448764BACKGROUND

  • Irani K, Rodriguez L, Doody DP, Goldstein AM. Botulinum toxin for the treatment of chronic constipation in children with internal anal sphincter dysfunction. Pediatr Surg Int. 2008 Jul;24(7):779-83. doi: 10.1007/s00383-008-2171-3. Epub 2008 Apr 29.

    PMID: 18443801BACKGROUND

  • Hata Y, Sasaki F, Uchino J. Sphincteromyectomy and sphincteroplasty in chronic constipation with megarectum. J Pediatr Surg. 1988 Feb;23(2):141-2. doi: 10.1016/s0022-3468(88)80143-x.

    PMID: 3343649BACKGROUND

  • Drossman DA. The functional gastrointestinal disorders and the Rome III process. Gastroenterology. 2006 Apr;130(5):1377-90. doi: 10.1053/j.gastro.2006.03.008. No abstract available.

    PMID: 16678553BACKGROUND

MeSH Terms

Interventions

Botulinum ToxinsBotulinum Toxins, Type A

Intervention Hierarchy (Ancestors)

MetalloendopeptidasesEndopeptidasesPeptide HydrolasesHydrolasesEnzymesEnzymes and CoenzymesMetalloproteasesBacterial ProteinsProteinsAmino Acids, Peptides, and ProteinsBacterial ToxinsToxins, BiologicalBiological Factors

Study Officials

  • Mohamed Seoudi

    Cairo University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Pediatric Surgery

Study Record Dates

First Submitted

January 9, 2015

First Posted

February 12, 2015

Study Start

September 1, 2014

Primary Completion

August 1, 2018

Study Completion

December 1, 2018

Last Updated

January 30, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will share

WOFAPS 2016

Locations

EG(1)