Evaluation of the Motor Activity, Cardiopulmonary Performance Capacity and Quality of Life in Patients Born With a Congenital Abdominal Wall Defect
NCT ID: NCT04644965
Last Updated: 2023-10-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
20 participants
OBSERVATIONAL
2020-10-05
2023-05-31
Brief Summary
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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
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Abdominal Wall Defect
patients born with an abdominal wall defect
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
Control Group
age and sex matched Control Group
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
6 Years
18 Years
ALL
No
Sponsors
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Medical University of Graz
OTHER
Responsible Party
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Locations
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Medical University of Graz
Graz, Styria, Austria
Countries
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References
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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.
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.
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.
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.
Other Identifiers
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32-231 ex 19/20
Identifier Type: -
Identifier Source: org_study_id
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