Laparoscopically Assisted Anorectal Pull-through Versus Posterior Sagittal Anorectoplasty

Not Applicable

• Conditions: Anorectal Malformation
• Interventions: Device: laparoscopic pull-through

• Registration Number: NCT03174028
• Lead Sponsor: Assiut University

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.

Detailed Description

The incidence of anorectal malformation \~1 in 5,000 More common in Down's syndrome and Cat-eye syndrome. Male \>female (60:40).It is classified into many types according to the degree of descent of the rectal pouch in the pelvis, the fistula between the rectum and the urinary system in males and genital system in females. The most common type in males is high anorectal malformation with rectourethral fistula

There are many historical operations for the management of the high type, but the most popular operation now is the posterior sagittal anorectoplasty which was published for the first time in 1982. Children undergoing posterior sagittal anorectoplasty may have lifelong bowel management problems of constipation, incontinence, and encopresis.

After the introduction of laparoscopy in pediatric surgery, many surgeons hope that the use of laparoscopy instead of posterior sagittal anorectoplasty may reduce the complications of the complications of the big incision and disturbance of sphincter mechanism which occur in posterior sagittal anorectoplasty operation. In addition to its role in diagnosis in complex anomalies like cloaca which is well established now. So the question is to what extent can the laparoscopy replace usual surgery for anorectal malformation.

Study Timeline

• Study First Submitted: 2017-05-30
• Status Verified: 2017-06
• Study First Submitted QC: 2017-06-01
• Study First Posted: 2017-06-02
• Last Update Submitted: 2017-06-10
• Last Update Posted: 2017-06-14
• Study Start: 2017-08-01
• Primary Completion: 2019-08-01
• Study Completion: 2020-01-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

-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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
laparoscopic group	laparoscopic pull-through	laparoscopic pull-through
posterior sagittal group	laparoscopic pull-through	posterior sagittal anorectoplasty

Primary Outcome Measures

Name	Time	Method
stool continence	3 months	questionaire about the degree of stool continence