NCT03174028

Brief Summary

Anorectal malformations are congenital malformations, in which the terminal part of the hindgut is abnormally placed and lies outside (partially or completely) the sphincter mechanism.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2017

Typical duration for not_applicable

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

First Submitted

Initial submission to the registry

May 30, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 2, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2017

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2019

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
Last Updated

June 14, 2017

Status Verified

June 1, 2017

Enrollment Period

2 years

First QC Date

May 30, 2017

Last Update Submit

June 10, 2017

Conditions

Anorectal Malformation

Outcome Measures

Primary Outcomes (1)

  • stool continence

    questionaire about the degree of stool continence

    3 months

Study Arms (2)

laparoscopic group

ACTIVE COMPARATOR

laparoscopic pull-through

Device: laparoscopic pull-through

posterior sagittal group

SHAM COMPARATOR

posterior sagittal anorectoplasty

Device: laparoscopic pull-through

Interventions

laparoscopic pull-throughDEVICE

laparoscopic pull-through

laparoscopic groupposterior sagittal group

Eligibility Criteria

Age6 Months - 3 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • all male and female childs aged from 6 months to the age of 3 years, in assiut university hospital, who have been diagnosed to have high anorectal malformation since birth and for whom colostomy was done

You may not qualify if:

  • all cases with low anomalies will be excluded.
  • Female child with vestibular anus
  • case with short distal pouch

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Anorectal Malformations

Condition Hierarchy (Ancestors)

Digestive System AbnormalitiesDigestive System DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DEVICE FEASIBILITY
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principle investigator

Study Record Dates

First Submitted

May 30, 2017

First Posted

June 2, 2017

Study Start

August 1, 2017

Primary Completion

August 1, 2019

Study Completion

January 1, 2020

Last Updated

June 14, 2017

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will not share