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

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at below P25 for all trials

Timeline

Completed

Started Oct 2020

Typical duration for all trials

Geographic Reach

1 country

1 active site

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

2.7 years study duration

Study Start

First participant enrolled

October 5, 2020

Completed

2 months until next milestone

First Submitted

Initial submission to the registry

November 19, 2020

Completed

6 days until next milestone

First Posted

Study publicly available on registry

November 25, 2020

Completed

3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2021

Completed

2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2023

Completed

Last Updated

October 5, 2023

Status Verified

January 1, 2023

Enrollment Period

5 months

First QC Date

November 19, 2020

Last Update Submit

October 4, 2023

Conditions

Abdominal Wall Defect

Outcome Measures

Primary Outcomes (4)

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

Study Arms (2)

Abdominal Wall Defect

patients born with an abdominal wall defect

Diagnostic Test: CombynTM Function & Spaces ECGDiagnostic Test: Blood TakingDiagnostic Test: SpiroergometryDiagnostic Test: Dordel Koch Test (DKT)Diagnostic Test: UltrasoundDiagnostic Test: Stance and gait analyses

Control Group

age and sex matched Control Group