NCT04644965

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 20 (actual)
• Sponsor: Medical University of Graz · Academic / Other
• Sex: All
• Age: 6 Years – 18 Years
• Healthy volunteers: —

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

Conditions

• Abdominal Wall Defect

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	CombynTM Function & Spaces ECG	Multi-frequency impedance measurement to assess the muscle and fat mass
DIAGNOSTIC_TEST	Blood Taking	Sampling of blood of the finger pad to assess liver function
DIAGNOSTIC_TEST	Spiroergometry	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_TEST	Dordel 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_TEST	Ultrasound	Ultrasound for abdominal wall muscles
DIAGNOSTIC_TEST	Stance and gait analyses	Stance and gait analyses for measuring the core stability

Timeline

• Start date: 2020-10-05
• Primary completion: 2021-02-28
• Completion: 2023-05-31
• First posted: 2020-11-25
• Last updated: 2023-10-05

Locations

1 site across 1 country: Austria