Laparoscopically Assisted Anorectal Pull-through Versus Posterior Sagittal Anorectoplasty

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-01

Study Completion Date

2020-01-01

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.

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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.

Conditions

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Anorectal Malformation

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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laparoscopic group

laparoscopic pull-through

Group Type ACTIVE_COMPARATOR

laparoscopic pull-through

Intervention Type DEVICE

laparoscopic pull-through

posterior sagittal group

posterior sagittal anorectoplasty

Group Type SHAM_COMPARATOR

laparoscopic pull-through

Intervention Type DEVICE

laparoscopic pull-through

Interventions

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laparoscopic pull-through

Intervention Type DEVICE

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