Health Related Quality of Life of Patients With Abdominal Wall Defects

NCT03960320 | Completed

• 1 other identifier: CK-001
• Study Type: observational
• Target: 65
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Quality of Life; Abdominal Wall Defect; Gastroschisis; Omphalocele

Keywords

KINDL; SDQ; SF-36

Outcome Measures

Primary Outcomes (3)

• Differences of Kindl test results of participants with congenital wall defects compared to a norm sample of German healthy children

  Kindl test for measuring the quality of life of participants with congenital wall defects compared to a norm sample of German healthy children

  Day 1. For one participant all of the questionnaires were administered in one day and for that participant the study lasted one day.

• Differences of SDQ test results of participants with congenital wall defects compared to a norm sample of German healthy children

  SDQ test for measuring the quality of life of participants with congenital wall defects compared to a norm sample of German healthy children

  Day 1. For one participant all of the questionnaires were administered in one day and for that participant the study lasted one day.

• Differences of SF-36 results of participants with congenital wall defects compared to a norm sample of German healthy adults

  SF-36 test for measuring the quality of life of participants with congenital wall defects compared to a norm sample of German healthy adults

  Day 1. For one participant all of the questionnaires were administered in one day and for that participant the study lasted one day.

Interventions

questionnaire OTHER

questionnaire to assess the quality of life of children using KINDL, SDQ and SF-36

Eligibility Criteria

• Age: 1 Day - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients with congenital abdominal wall defect, e.g. gastroschisis or omphalocele

You may qualify if:

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

You may not qualify if:

• Not surgically corrected in our department
• Non-Survivor

Sponsors & Collaborators

• Universität des Saarlandes: lead

MeSH Terms

Conditions

Gastroschisis; Hernia, Umbilical

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Musculoskeletal Abnormalities; Musculoskeletal Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Infant, Newborn, Diseases; Hernia, Ventral

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Clemens-Magnus Meier, MD

  Universität des Saarlandes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2019
• First Posted: May 23, 2019
• Study Start: May 1, 2014
• Primary Completion: December 31, 2015
• Study Completion: December 31, 2015
• Last Updated: May 23, 2019

Record last verified: 2019-05