Laparoscopically Assisted Anorectal Pull-through Versus Posterior Sagittal Anorectoplasty

Study Overview
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Brief Summary
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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
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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.

Official Title
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Laparoscopically Assisted Anorectal Pull-through Versus Posterior Sagittal Anorectoplasty for High and Intermediate Anorectal Malformations : A Comparative Study

Conditions
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Anorectal Malformation

Intervention / Treatment
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* Device: laparoscopic pull-through


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 3 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: laparoscopic group<br>laparoscopic pull-through | Device: laparoscopic pull-through<br>* laparoscopic pull-through<br>|
| Sham Comparator: posterior sagittal group<br>posterior sagittal anorectoplasty | Device: laparoscopic pull-through<br>* laparoscopic pull-through<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| stool continence | questionaire about the degree of stool continence | 3 months |