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

Completed

• Conditions: Abdominal Wall Defect
• Interventions: Diagnostic Test: CombynTM Function & Spaces ECG; Diagnostic Test: Blood Taking; Diagnostic Test: Spiroergometry; Diagnostic Test: Dordel Koch Test (DKT); Diagnostic Test: Ultrasound; Diagnostic Test: Stance and gait analyses

• Registration Number: NCT04644965
• Lead Sponsor: Medical University of Graz

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

Detailed Description

Not available

Study Timeline

• Study Start: 2020-10-05
• Study First Submitted: 2020-11-19
• Study First Submitted QC: 2020-11-19
• Study First Posted: 2020-11-25
• Primary Completion: 2021-02-28
• Status Verified: 2023-01
• Study Completion: 2023-05-31
• Last Update Submitted: 2023-10-04
• Last Update Posted: 2023-10-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• All patients born with an abdominal wall defect

Exclusion Criteria

• mental disease

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Abdominal Wall Defect	Spiroergometry	patients born with an abdominal wall defect
Abdominal Wall Defect	Dordel Koch Test (DKT)	patients born with an abdominal wall defect
Control Group	Dordel Koch Test (DKT)	age and sex matched Control Group
Control Group	Ultrasound	age and sex matched Control Group
Abdominal Wall Defect	CombynTM Function & Spaces ECG	patients born with an abdominal wall defect
Abdominal Wall Defect	Blood Taking	patients born with an abdominal wall defect
Abdominal Wall Defect	Ultrasound	patients born with an abdominal wall defect
Abdominal Wall Defect	Stance and gait analyses	patients born with an abdominal wall defect
Control Group	CombynTM Function & Spaces ECG	age and sex matched Control Group
Control Group	Blood Taking	age and sex matched Control Group
Control Group	Stance and gait analyses	age and sex matched Control Group
Control Group	Spiroergometry	age and sex matched Control Group

Primary Outcome Measures

Name	Time	Method
Motor Activity	30 minutes	Comparison of the Dordel Koch Test between the two groups. (T-Test or Mann-Withney-U)
Cardiopulmonary Performance Capacity - lung function	30 minutes	Comparing relative lung function \[%\] between the two groups.(T-Test or Mann-Withney-U)
Cardiopulmonary Performance Capacity - peak VO2	30 minutes	Comparing peak VO2 between the two groups.(T-Test or Mann-Withney-U)
Gastrointestinal Quality of Life	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)

Trial Locations

Locations (1)

Medical University of Graz; 🇦🇹 Graz, Styria, Austria