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Laparoscopically Assisted Anorectal Pull-through Versus Posterior Sagittal Anorectoplasty

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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

Tracking Information
First Submitted Date  ICMJE May 30, 2017
First Posted Date  ICMJE June 2, 2017
Last Update Posted Date June 14, 2017
Estimated Study Start Date  ICMJE August 1, 2017
Estimated Primary Completion Date August 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 1, 2017)
stool continence [ Time Frame: 3 months ]
questionaire about the degree of stool continence
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03174028 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Laparoscopically Assisted Anorectal Pull-through Versus Posterior Sagittal Anorectoplasty
Official Title  ICMJE Laparoscopically Assisted Anorectal Pull-through Versus Posterior Sagittal Anorectoplasty for High and Intermediate Anorectal Malformations : A Comparative Study
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Condition  ICMJE Anorectal Malformation
Intervention  ICMJE Device: laparoscopic pull-through
laparoscopic pull-through
Study Arms  ICMJE
  • Active Comparator: laparoscopic group
    laparoscopic pull-through
    Intervention: Device: laparoscopic pull-through
  • Sham Comparator: posterior sagittal group
    posterior sagittal anorectoplasty
    Intervention: Device: laparoscopic pull-through
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: June 1, 2017)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 1, 2020
Estimated Primary Completion Date August 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Months to 3 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03174028
Other Study ID Numbers  ICMJE lAR
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Ahmed Gamal Abdelmalek, Assiut University
Study Sponsor  ICMJE Assiut University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Assiut University
Verification Date June 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP