Health Related Quality of Life of Patients With Abdominal Wall Defects
Condition: Quality of Life; Abdominal Wall Defect; Gastroschisis; Omphalocele
MeSH terms: Gastroschisis; Hernia, Umbilical
Study type: Observational

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.
    

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.
    

Intervention name(s): questionnaire
Intervention type(s): Other
Intervention description(s): questionnaire to assess the quality of life of children using KINDL, SDQ and SF-36
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with congenital abdominal wall defect, e.g. gastroschisis or omphalocele
      
Keywords: KINDL; SDQ; SF-36