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

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-10-05

Study Completion Date

2023-05-31

Brief Summary

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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

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Conditions

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Abdominal Wall Defect

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Abdominal Wall Defect

patients born with an abdominal wall defect

CombynTM Function & Spaces ECG

Intervention Type DIAGNOSTIC_TEST

Multi-frequency impedance measurement to assess the muscle and fat mass

Blood Taking

Intervention Type DIAGNOSTIC_TEST

Sampling of blood of the finger pad to assess liver function

Spiroergometry

Intervention Type DIAGNOSTIC_TEST

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)

Intervention Type DIAGNOSTIC_TEST

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

Intervention Type DIAGNOSTIC_TEST

Ultrasound for abdominal wall muscles

Stance and gait analyses

Intervention Type DIAGNOSTIC_TEST

Stance and gait analyses for measuring the core stability

Control Group

age and sex matched Control Group

CombynTM Function & Spaces ECG

Intervention Type DIAGNOSTIC_TEST

Multi-frequency impedance measurement to assess the muscle and fat mass

Blood Taking

Intervention Type DIAGNOSTIC_TEST

Sampling of blood of the finger pad to assess liver function

Spiroergometry

Intervention Type DIAGNOSTIC_TEST

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)

Intervention Type DIAGNOSTIC_TEST

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

Intervention Type DIAGNOSTIC_TEST

Ultrasound for abdominal wall muscles

Stance and gait analyses

Intervention Type DIAGNOSTIC_TEST

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

Intervention Type DIAGNOSTIC_TEST

Blood Taking

Sampling of blood of the finger pad to assess liver function

Intervention Type DIAGNOSTIC_TEST

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

Intervention Type DIAGNOSTIC_TEST

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

Intervention Type DIAGNOSTIC_TEST

Ultrasound

Ultrasound for abdominal wall muscles

Intervention Type DIAGNOSTIC_TEST

Stance and gait analyses

Stance and gait analyses for measuring the core stability

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* All patients born with an abdominal wall defect

Exclusion Criteria

* mental disease
Minimum Eligible Age

6 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University of Graz

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Medical University of Graz

Graz, Styria, Austria

Site Status

Countries

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Austria

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.

Reference Type BACKGROUND
PMID: 27982137 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31874371 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25280647 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11077588 (View on PubMed)

Other Identifiers

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32-231 ex 19/20

Identifier Type: -

Identifier Source: org_study_id

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