Abdominal Wall DefectNCT04644965
Evaluation of the Motor Activity, Cardiopulmonary Performance Capacity and Quality of Life in Patients Born With a Congenital Abdominal Wall Defect
An observational study of Abdominal Wall Defect, run by Medical University of Graz at 1 site in Austria.
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. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Abdominal Wall Defect
- What is being tested?
- CombynTM Function & Spaces ECG, Blood Taking and Spiroergometry
- How many people
- 20 participants
- Where
- 1 siteAustria
- Study dates
- 5 Oct 2020to 31 May 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- Child, Adult
Study population: All patients born with an abdominal wall defect between 6-18years old are invited personally for examinations.
Who may be able to join
- All patients born with an abdominal wall defect
Who cannot join
- mental disease
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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
- Conditions
- Abdominal Wall Defect
- Being tested
- CombynTM Function & Spaces ECG, Blood Taking, Spiroergometry, Dordel Koch Test (DKT), Ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CombynTM Function & Spaces ECGDiagnostic test
Multi-frequency impedance measurement to assess the muscle and fat mass
Blood TakingDiagnostic test
Sampling of blood of the finger pad to assess liver function
SpiroergometryDiagnostic 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)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
UltrasoundDiagnostic test
Ultrasound for abdominal wall muscles
Stance and gait analysesDiagnostic test
Stance and gait analyses for measuring the core stability
| Study group | Role | What they receive |
|---|---|---|
| Abdominal Wall Defect | patients born with an abdominal wall defect Receives: 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 | |
| Control Group | age and sex matched Control Group Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Motor Activity
Comparison of the Dordel Koch Test between the two groups. (T-Test or Mann-Withney-U)
Measured: 30 minutes
Cardiopulmonary Performance Capacity - lung function
Comparing relative lung function [%] between the two groups.(T-Test or Mann-Withney-U)
Measured: 30 minutes
Cardiopulmonary Performance Capacity - peak VO2
Comparing peak VO2 between the two groups.(T-Test or Mann-Withney-U)
Measured: 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)
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2020
- Study start5 Oct 2020
- Primary completion28 Feb 2021
- Study completion31 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Abdominal Wall DefectStudies of the same condition, open and under way.
- More trials run by Medical University of GrazThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04644965
- Sponsor's protocol ID
- 32-231 ex 19/20
- Status last verified
- Jan 2023
- First submitted
- 19 Nov 2020
- Last updated
- 5 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 27982137Snoep 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.
PubMed 31874371Harris 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.
PubMed 25280647Kaiser 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.
PubMed 11077588
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Motor Activity, Cardiopulmonary Performance Capacity and Quality of Life in Patients Born With a Congenital Abdominal Wall Defect
- ClinicalTrials.gov ID
- NCT04644965
- Acronym / sponsor ID
- 32-231 ex 19/20
- Conditions
- Abdominal Wall Defect
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- 5 Oct 2020 (actual)
- Primary completion
- 28 Feb 2021 (actual)
- Study completion
- 31 May 2023 (actual)
- First posted
- 25 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Abdominal Wall Defect | – | 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 analysespatients born with an abdominal wall defect |
| Control Group | – | 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 analysesage and sex matched Control Group |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- All patients born with an abdominal wall defect between 6-18years old are invited personally for examinations.
Key inclusion criteria (1 listed)
- All patients born with an abdominal wall defect
Key exclusion criteria (1 listed)
- mental disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CombynTM Function & Spaces ECGMulti-frequency impedance measurement to assess the muscle and fat mass | Diagnostic test | Abdominal Wall Defect, Control Group |
| Blood TakingSampling of blood of the finger pad to assess liver function | Diagnostic test | Abdominal Wall Defect, Control Group |
| SpiroergometrySpiroergometry 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 | Diagnostic test | Abdominal Wall Defect, Control Group |
| 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 | Diagnostic test | Abdominal Wall Defect, Control Group |
| UltrasoundUltrasound for abdominal wall muscles | Diagnostic test | Abdominal Wall Defect, Control Group |
| Stance and gait analysesStance and gait analyses for measuring the core stability | Diagnostic test | Abdominal Wall Defect, Control Group |
Primary outcome
Motor Activity
Time frame: 30 minutes
Comparison of the Dordel Koch Test between the two groups. (T-Test or Mann-Withney-U)
Cardiopulmonary Performance Capacity - lung function
Time frame: 30 minutes
Comparing relative lung function [%] between the two groups.(T-Test or Mann-Withney-U)
Cardiopulmonary Performance Capacity - peak VO2
Time frame: 30 minutes
Comparing peak VO2 between the two groups.(T-Test or Mann-Withney-U)
Gastrointestinal Quality of Life
Time frame: 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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2023.
- Background: PubMed 27982137Frybova 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.
- Background: PubMed 31874371Snoep 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.
- Background: PubMed 25280647Harris 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.
- Background: PubMed 11077588Kaiser 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Abdominal Wall Defect, run by Medical University of Graz at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Motor Activity (time frame: 30 minutes). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04644965, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2023.