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

Abdominal Wall Defect Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04644965
• Other study ID #: 32-231 ex 19/20
• Status: Completed
• Start date: October 5, 2020
• Est. completion date: May 31, 2023

Study information

• Verified date: January 2023
• Source: Medical University of Graz
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: May 31, 2023
• Est. primary completion date: February 28, 2021
• Gender: All
• Age group: 6 Years to 18 Years

Eligibility

Inclusion Criteria:

• All patients born with an abdominal wall defect

Exclusion Criteria:

• mental disease

Related Conditions & MeSH terms

• Abdominal Wall Defect

Intervention

Diagnostic Test:
• CombynTM Function & Spaces ECG
Multi-frequency impedance measurement to assess the muscle and fat mass
• Blood Taking
Sampling of blood of the finger pad to assess liver function
• 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
• 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
• Ultrasound
Ultrasound for abdominal wall muscles
• Stance and gait analyses
Stance and gait analyses for measuring the core stability

Locations

Country	Name	City	State
Austria	Medical University of Graz	Graz	Styria

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Graz

Country where clinical trial is conducted

Austria, 

References & Publications (4)

Frybova B, Kokesova A, Zemkova D, Mixa V, Vlk R, Rygl M. Quality of life in patients with gastroschisis is comparable with the general population: A questionnaire survey. Biomed Pap Med Fac Univ Palacky Olomouc Czech Repub. 2017 Mar;161(1):75-79. doi: 10.5507/bp.2016.059. Epub 2016 Dec 13. — View Citation

Harris EL, Minutillo C, Hart S, Warner TM, Ravikumara M, Nathan EA, Dickinson JE. The long term physical consequences of gastroschisis. J Pediatr Surg. 2014 Oct;49(10):1466-70. doi: 10.1016/j.jpedsurg.2014.03.008. — View Citation

Kaiser MM, Kahl F, von Schwabe C, Halsband H. [Omphalocele and gastroschisis. Outcome--complications--follow-up--quality of life]. Chirurg. 2000 Oct;71(10):1256-62. doi: 10.1007/s001040051212. German. — View Citation

Snoep MC, de Heus R, Manten GTR, Lap CCMM, Snoeker BAM, Lindeboom MYA. Gastro-intestinal function and quality of life are favorable in adolescent and adult gastroschisis patients. Early Hum Dev. 2020 Feb;141:104936. doi: 10.1016/j.earlhumdev.2019.104936. Epub 2019 Dec 23. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Motor Activity	Comparison of the Dordel Koch Test between the two groups. (T-Test or Mann-Withney-U)	30 minutes
Primary	Cardiopulmonary Performance Capacity - lung function	Comparing relative lung function [%] between the two groups.(T-Test or Mann-Withney-U)	30 minutes
Primary	Cardiopulmonary Performance Capacity - peak VO2	Comparing peak VO2 between the two groups.(T-Test or Mann-Withney-U)	30 minutes
Primary	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