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.
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
- Conditions the study is for
- Quality of Life, Abdominal Wall Defect, Gastroschisis
- 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.
- Conditions
- Quality of Life, Abdominal Wall Defect, Gastroschisis, Omphalocele
- 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.
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.
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.
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.
- First posted23 May 2019
- Study start1 May 2014
- Primary completion31 Dec 2015
- Study completion31 Dec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Universität des Saarlandes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Clemens-Magnus Meier, MD, Principal investigator, Universität des Saarlandes
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.
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health Related Quality of Life of Patients With Abdominal Wall Defects
- ClinicalTrials.gov ID
- NCT03960320
- Acronym / sponsor ID
- CK-001
- Conditions
- Quality of Life, Abdominal Wall Defect, Gastroschisis, Omphalocele
- Keywords
- KINDL, SDQ, SF-36
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Universität des SaarlandesUniversity, hospital or other
- Study start
- 1 May 2014 (actual)
- Primary completion
- 31 Dec 2015 (actual)
- Study completion
- 31 Dec 2015 (actual)
- First posted
- 23 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 1 day to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients with congenital abdominal wall defect, e.g. gastroschisis or omphalocele
Key inclusion criteria (3 listed)
- Congenital abdominal wall defect
- Surgically corrected in our department
- Survivor
Key exclusion criteria (2 listed)
- Not surgically corrected in our department
- Non-Survivor
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| questionnairequestionnaire to assess the quality of life of children using KINDL, SDQ and SF-36 | Other | – |
Primary outcome
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2019.
- Individual participant dataSharing planned: Undecided. The publication of the data in anonymous form is planned.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clemens-Magnus Meier, MD principal investigator
Universität des Saarlandes
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.