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

Medical University of Graz

Status: Completed

Conditions: Abdominal Wall Defect

Treatments: Diagnostic Test: Stance and gait analyses; Diagnostic Test: Dordel Koch Test (DKT); Diagnostic Test: CombynTM Function & Spaces ECG; Diagnostic Test: Blood Taking; Diagnostic Test: Ultrasound; Diagnostic Test: Spiroergometry

Study type: Observational

Funder types: Other

Identifiers

NCT04644965

32-231 ex 19/20

Details and patient eligibility

About

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

Enrollment: 20 patients

Sex: All

Ages: 6 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• All patients born with an abdominal wall defect

Exclusion criteria

• mental disease

Trial design

20 participants in 2 patient groups

Abdominal Wall Defect

Description:

patients born with an abdominal wall defect

Treatment:

Diagnostic Test: Blood Taking

Diagnostic Test: Dordel Koch Test (DKT)

Diagnostic Test: Stance and gait analyses

Diagnostic Test: Spiroergometry

Diagnostic Test: CombynTM Function & Spaces ECG

Diagnostic Test: Ultrasound

Control Group

Description:

age and sex matched Control Group

Treatment:

Diagnostic Test: Blood Taking

Diagnostic Test: Dordel Koch Test (DKT)

Diagnostic Test: Stance and gait analyses

Diagnostic Test: Spiroergometry

Diagnostic Test: CombynTM Function & Spaces ECG

Diagnostic Test: Ultrasound