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Health Related Quality of Life of Patients With Abdominal Wall Defects

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03960320
Recruitment Status : Completed
First Posted : May 23, 2019
Last Update Posted : May 23, 2019
Sponsor:
Information provided by (Responsible Party):
Saarland University

Brief Summary:
Examination of the health-related quality of life of patients operated on due to congenital defects of the abdominal wall after birth with the questionnaires KINDL, SDQ and SF-36.

Condition or disease Intervention/treatment
Quality of Life Abdominal Wall Defect Gastroschisis Omphalocele Other: questionnaire

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Study Type : Observational
Actual Enrollment : 65 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Health Related Quality of Life of Patients With Abdominal Wall Defects
Actual Study Start Date : May 1, 2014
Actual Primary Completion Date : December 31, 2015
Actual Study Completion Date : December 31, 2015

Resource links provided by the National Library of Medicine



Intervention Details:
  • Other: questionnaire
    questionnaire to assess the quality of life of children using KINDL, SDQ and SF-36


Primary Outcome Measures :
  1. Differences of Kindl test results of participants with congenital wall defects compared to a norm sample of German healthy children [ Time Frame: Day 1. For one participant all of the questionnaires were administered in one day and for that participant the study lasted one day. ]
    Kindl test for measuring the quality of life of participants with congenital wall defects compared to a norm sample of German healthy children

  2. Differences of SDQ test results of participants with congenital wall defects compared to a norm sample of German healthy children [ Time Frame: Day 1. For one participant all of the questionnaires were administered in one day and for that participant the study lasted one day. ]
    SDQ test for measuring the quality of life of participants with congenital wall defects compared to a norm sample of German healthy children

  3. Differences of SF-36 results of participants with congenital wall defects compared to a norm sample of German healthy adults [ Time Frame: Day 1. For one participant all of the questionnaires were administered in one day and for that participant the study lasted one day. ]
    SF-36 test for measuring the quality of life of participants with congenital wall defects compared to a norm sample of German healthy adults



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 40 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with congenital abdominal wall defect, e.g. gastroschisis or omphalocele
Criteria

Inclusion Criteria:

  • Congenital abdominal wall defect
  • Surgically corrected in our department
  • Survivor

Exclusion Criteria:

  • Not surgically corrected in our department
  • Non-Survivor

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03960320


Sponsors and Collaborators
Saarland University
Investigators
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Principal Investigator: Clemens-Magnus Meier, MD Saarland University

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Responsible Party: Saarland University
ClinicalTrials.gov Identifier: NCT03960320    
Other Study ID Numbers: CK-001
First Posted: May 23, 2019    Key Record Dates
Last Update Posted: May 23, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: The publication of the data in anonymous form is planned.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Saarland University:
KINDL
SDQ
SF-36
Additional relevant MeSH terms:
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Gastroschisis
Hernia, Umbilical
Musculoskeletal Abnormalities
Musculoskeletal Diseases
Congenital Abnormalities
Hernia, Abdominal
Hernia
Pathological Conditions, Anatomical
Infant, Newborn, Diseases
Hernia, Ventral