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Completed

NCT Number: NCT04644965

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

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

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Key information

Conditions

Abdominal Wall Defect

Age range

6 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Medical University of Graz

Graz, Styria, 8036, Austria

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All patients born with an abdominal wall defect

Exclusion criteria

  • mental disease

Treatment and study plan

CombynTM Function & Spaces ECG

Diagnostic Test

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

Blood Taking

Diagnostic Test

Sampling of blood of the finger pad to assess liver function

Spiroergometry

Diagnostic Test

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

Dordel Koch Test (DKT)

Diagnostic Test

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

Ultrasound

Diagnostic Test

Ultrasound for abdominal wall muscles

Stance and gait analyses

Diagnostic Test

Stance and gait analyses for measuring the core stability

Primary outcomes

  1. Motor Activity

    Time frame: 30 minutes

    Comparison of the Dordel Koch Test between the two groups. (T-Test or Mann-Withney-U)

  2. Cardiopulmonary Performance Capacity - lung function

    Time frame: 30 minutes

    Comparing relative lung function [%] between the two groups.(T-Test or Mann-Withney-U)

  3. Cardiopulmonary Performance Capacity - peak VO2

    Time frame: 30 minutes

    Comparing peak VO2 between the two groups.(T-Test or Mann-Withney-U)

  4. Gastrointestinal Quality of Life

    Time frame: 15 minutes

    Gastrointestinal 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)

Sponsors and collaborators

Lead sponsor

Medical University of Graz

Other

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2023
First posted
Nov 25, 2020
Registry last updated
Oct 5, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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