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

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 Overview

• Status: Completed
• Conditions: Abdominal Wall Defect
• Intervention / Treatment: 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

• Study Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• Austria
  • Styria
    • Graz, Styria, Austria, 8036
      • Medical University of Graz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

All patients born with an abdominal wall defect between 6-18years old are invited personally for examinations.

Description

Inclusion Criteria:

• All patients born with an abdominal wall defect

Exclusion Criteria:

• mental disease

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Abdominal Wall Defect; patients born with an abdominal wall defect	Diagnostic test: CombynTM Function & Spaces ECG; Multi-frequency impedance measurement to assess the muscle and fat mass; Diagnostic test: Blood Taking; Sampling of blood of the finger pad to assess liver function; 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; 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; Diagnostic test: Ultrasound; Ultrasound for abdominal wall muscles; Diagnostic test: Stance and gait analyses; Stance and gait analyses for measuring the core stability
Control Group; age and sex matched Control Group	Diagnostic test: CombynTM Function & Spaces ECG; Multi-frequency impedance measurement to assess the muscle and fat mass; Diagnostic test: Blood Taking; Sampling of blood of the finger pad to assess liver function; 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; 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; Diagnostic test: Ultrasound; Ultrasound for abdominal wall muscles; Diagnostic test: Stance and gait analyses; Stance and gait analyses for measuring the core stability

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Medical University of Graz

Publications and helpful links

General 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 5, 2020
• Primary Completion (Actual): February 28, 2021
• Study Completion (Actual): May 31, 2023

Study Registration Dates

• First Submitted: November 19, 2020
• First Submitted That Met QC Criteria: November 19, 2020
• First Posted (Actual): November 25, 2020

Study Record Updates

• Last Update Posted (Actual): October 5, 2023
• Last Update Submitted That Met QC Criteria: October 4, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 32-231 ex 19/20

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No