Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Laparoscopically Assisted Anorectal Pull-through Versus Posterior Sagittal Anorectoplasty

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03174028
Recruitment Status : Not yet recruiting
First Posted : June 2, 2017
Last Update Posted : June 14, 2017
Sponsor:
Information provided by (Responsible Party):
Ahmed Gamal Abdelmalek, 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.

Condition or disease Intervention/treatment Phase
Anorectal Malformation Device: laparoscopic pull-through Not Applicable

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: Laparoscopically Assisted Anorectal Pull-through Versus Posterior Sagittal Anorectoplasty for High and Intermediate Anorectal Malformations : A Comparative Study
Estimated Study Start Date : August 1, 2017
Estimated Primary Completion Date : August 1, 2019
Estimated Study Completion Date : January 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: laparoscopic group
laparoscopic pull-through
Device: laparoscopic pull-through
laparoscopic pull-through

Sham Comparator: posterior sagittal group
posterior sagittal anorectoplasty
Device: laparoscopic pull-through
laparoscopic pull-through




Primary Outcome Measures :
  1. stool continence [ Time Frame: 3 months ]
    questionaire about the degree of stool continence



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   6 Months to 3 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Layout table for additonal information
Responsible Party: Ahmed Gamal Abdelmalek, principle investigator, Assiut University
ClinicalTrials.gov Identifier: NCT03174028     History of Changes
Other Study ID Numbers: lAR
First Posted: June 2, 2017    Key Record Dates
Last Update Posted: June 14, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Anorectal Malformations
Congenital Abnormalities
Digestive System Abnormalities
Digestive System Diseases