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Evaluation of the Motor Activity, Cardiopulmonary Performance Capacity and Quality of Life in Patients Born With a Congenital Abdominal Wall Defect

Evaluation of the Motor Activity, Cardiopulmonary Performance Capacity and Quality of Life in Patients Born With a Congenital Abdominal Wall Defect

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04644965
Enrollment
20
Registered
2020-11-25
Start date
2020-10-05
Completion date
2023-05-31
Last updated
2023-10-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Abdominal Wall Defect

Brief summary

The two most common congenital abdominal wall defects (AWD) are gastroschisis and omphalocele. Prenatal detection is often possible and the defects are differentiated by the presence or absence of a sac around the eviscerated organs. A omphalocele occurs in 0.6-4.8 in 10,000 live births compared to 4.5 in 10,000 live births with gastroschisis. In the last years a rising incidence of gastroschisis has been shown worldwide. Both forms of AWDs necessitate early surgical intervention, mostly in one or two stages, and support at an intensive care unit in the first days of life. Additionally, patients need parenteral feeding in the first weeks of life. The outcome depends on the size of the defect and on the associated malformations. The literature about long-term outcome of these malformations is scarce. Some publications have reported long-term complications like redo-surgical procedures because of fascial gaps or umbilical or incisional hernias. Furthermore, stool irregularities, abdominal pain and several admission to the hospital due to ileus or sub-ileus have been described. Additionally, half of the patients are unsatisfied with the cosmetic result. Some other studies have shown that children born with an AWD have the same quality of life (QoL) compared with the healthy community. Nevertheless, patients with AWDs need a standardized, structured and multimodal long-time follow-up program to be able to detect any problems early and give advice to understand their illness in order to achieve the same QoL as healthy children. Therefore, the aim of this dissertation will be: * to prospectively assess the motor activity, cardiopulmonary performance capacity and QoL of patients treated with AWDs in our Department * to suggest a new standardized follow-up protocol for patients born with an AWD

Interventions

DIAGNOSTIC_TESTCombynTM Function & Spaces ECG

Multi-frequency impedance measurement to assess the muscle and fat mass

DIAGNOSTIC_TESTBlood Taking

Sampling of blood of the finger pad to assess liver function

DIAGNOSTIC_TESTSpiroergometry

Spiroergometry to assess cardiopulmonary capacity. The intensity will be raised in steps until total exhaustion. In between each step we will take blood of the ear lobe to determine the lactate level

DIAGNOSTIC_TESTDordel Koch Test (DKT)

Dordel Koch Test (DKT) to evaluate the motor activity. The DKT is a heterogeneous test battery for children and adolescents and consists of seven parts: lateral jumping, sit and reach, situps, long stand jump, one-legged stand, push-ups and 6-min-run

DIAGNOSTIC_TESTUltrasound

Ultrasound for abdominal wall muscles

DIAGNOSTIC_TESTStance and gait analyses

Stance and gait analyses for measuring the core stability

Sponsors

Medical University of Graz
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
6 Years to 18 Years

Inclusion criteria

* All patients born with an abdominal wall defect

Exclusion criteria

* mental disease

Design outcomes

Primary

MeasureTime frameDescription
Motor Activity30 minutesComparison of the Dordel Koch Test between the two groups. (T-Test or Mann-Withney-U)
Cardiopulmonary Performance Capacity - lung function30 minutesComparing relative lung function \[%\] between the two groups.(T-Test or Mann-Withney-U)
Cardiopulmonary Performance Capacity - peak VO230 minutesComparing peak VO2 between the two groups.(T-Test or Mann-Withney-U)
Gastrointestinal Quality of Life15 minutesGastrointestinal Quality of Life Index (GIQLI): most desirable option: 4 points, least desirable option: 0 points GIQLI score: sum of the points - Score Range: 0-148 Compare the mean between the two groups (T-Test or Mann-Withney-U)

Countries

Austria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026