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Quality of LifeNCT03960320

Health Related Quality of Life of Patients With Abdominal Wall Defects

An observational study of Quality of Life and Abdominal Wall Defect, run by Universität des Saarlandes.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 1 day to 40 years
What is being tested?
questionnaire
How many people
65 participants
Where
No sites listed yet
Study dates
1 May 2014to 31 Dec 2015
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 day to 40 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

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

Who may be able to join

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

Who cannot join

  • Not surgically corrected in our department
  • Non-Survivor

About this study

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.

Read the detailed description

Data of all patients with a congenital abdominal wall defect (CAWD) undergoing surgical repair between 1996 and 2011 in the Department of Pediatric Surgery of the Clinic for General Surgery, Visceral, Vascular and Pediatric Surgery of the Saarland University Medical Center in Homburg were retrieved from surgical health records. Up to 2001 these records were paper based and later on electronically available (SAP enhancement package 7 for SAP ERP 6.0: 2013, Walldorf, Germany). Except epidemiological data the type of disease, data concerning birth details, pre- and postnatal course, treatment, weight and growth development have been collected electronically.

Gastroschisis or omphalocele can be simple or complex. The investigators defined complex as involvement of stenosis, atresia, ischemia, volvulus or perforation, closed or vanishing gastroschisis, and chromosomal anomalies. Giant omphalocele was considered as complex as well. The type of the primary operative procedure, primary closure of the defect or other (patch plastic etc.), was also noted. The implementation of silo technique with delayed primary closure was regarded as primary closure.

A prospective analysis was conducted by a survey with age-related questionnaires to investigate the patient´s HrQoL. The study protocol was approved by the ethical board of Aerztekammer of Saarland (Nr. 206/2013). Informed consent was given by all participating patients or their guardians.

The data collection was carried out by telephone interview, personal interview or by regular mail. The interview was always conducted by the same person, a medical student (KK). The data was collected using age related questionnaires. Together with the collection of clinical data the investigators used the validated questionnaires KINDL, SDQ and SF-36.

The KINDL questionnaire (www.KINDL.org) is a specifically developed questionnaire for children, which was developed to assess the HrQoL of life of children and adolescents. The reference values were published as part of the study "The Children and Youth Health Survey (KIGGS)" by the Robert Koch Institute, Berlin, Germany and covers the health data of 17.641 children and adolescents in Germany aged 0-17 years.

The SDQ (Strengths and Difficulties Questionnaire) is the second questionnaire that was used. The investigators used the Woerner adjustment of the SDQ as it was transferred to a German cohort.

Since there are also some adult patients in the patient collective, the investigators have also integrated the SF-36, which was developed for adolescents and adult patients.

The SF-36 is an internationally recognized and widely used questionnaire for the assessment of health-related quality of life. It records eight different dimensions (= subscales) of quality of life: physical functioning, physical role function, pain, general health perception, vitality, social functioning, emotional role function and psychological well-being. Additionally, the overall physical sum score and overall psychological sum score are listed. German reference values are available as a reference for the SF-36.

In addition, disease specific questions were asked. These included somatic and clinical data about gastrointestinal function, cosmetic aspects and scars, problems during pregnancy of the child, actual clinical health status and psycho-social development. Answers were given as precise numbers or rated according to the following LIKERT-scale with these possibilities "never-seldom-sometimes-often-always".

All data were collected and processed in an Excel spreadsheet (Microsoft® Excel®, Microsoft Corporation, Redmond, Washington, USA). The statistical analysis was carried out with SPSS (IBM® SPSS® Statistics, Version 25, International Business Machines Corporation (IBM), Armonk, New York, USA) and Excel as well.

Being tested
questionnaire
Keywords
KINDL, SDQ, SF-36
Medical subject headings
Gastroschisis, Hernia, Umbilical

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • questionnaireOther

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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

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

  2. 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

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

  3. 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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 May 2019
  2. Study start1 May 2014
  3. Primary completion31 Dec 2015
  4. Study completion31 Dec 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
65 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03960320
Sponsor's protocol ID
CK-001
Status last verified
May 2019
First submitted
13 May 2019
Last updated
23 May 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: The publication of the data in anonymous form is planned.

Questions about this trial

What is this clinical trial studying?

An observational study of Quality of Life and Abdominal Wall Defect, run by Universität des Saarlandes.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 May 2019. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2019.

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