Functional Abdominal Wall Reconstruction

Functional Abdominal Wall Reconstruction in Patients With Prune Belly Syndrome

Assessement of outcomes of functional reconstruction of underdeveloped abdominal muscles with the use od pedicled Vastus Lateralis Muscle flaps.

Study Overview

• Status: Active, not recruiting
• Conditions: Prune Belly Syndrome
• Intervention / Treatment: Procedure: Bilateral Pedicled Vastus Lateralis Muscle Flaps Transposition

• Study Type: Observational
• Enrollment (Actual): 7

Contacts and Locations

Study Locations

• Poland
  • Gliwice, Poland
    • Maria Sklodowska Curie Memorial National Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Pediatric patients diagnosed with Prune Belly syndrome suffering from symptoms related to abdominal wall insufficiency

Description

Inclusion Criteria:

• Patients diagnoes with Prune Belly Syndrome
• severe underdevelopment of rectus abdomini muscles
• patients who underwent microsurgical bipedicled vastus lateralis muscle flaps transposition
• patient undery 18 y.o.

Exclusion Criteria:

• Patient over the age of 18
• Patients who did not agreed for proposed microsurgical reconstruction of the abdominal wall

Exclusion Criteria: Patient over the age of 18

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Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Electromyography	To assess the proper function of transposed muscles the electromyographic tests were used to assess the proper electroactivity of transposed vastus lateralis muscles. The measured values of amplitude (mV) and conduction velocity(ms) were analyzed.	followup reached 96months
Motor tests - performance of ''sit-up''-like movement	Patients were asked to perform situp-like movement with legs fasetned before surgical transposition of muscles and then 12 months postoperatively. It was assessed in 0/1 manner. 0 - patient not able to do the sit-up, 1 - patient able to do the sit-up	Followup reached 96 months

Collaborators and Investigators

• Sponsor: Maria Sklodowska-Curie National Research Institute of Oncology
• Collaborators: Górnośląskie Centrum Zdrowia Dziecka

Publications and helpful links

General Publications

• Lopes RI, Baker LA, Denes FT. Modern management of and update on prune belly syndrome. J Pediatr Urol. 2021 Aug;17(4):548-554. doi: 10.1016/j.jpurol.2021.04.010. Epub 2021 Apr 24.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): March 1, 2024
• Study Completion (Estimated): September 30, 2026

Study Registration Dates

• First Submitted: April 1, 2025
• First Submitted That Met QC Criteria: April 8, 2025
• First Posted (Actual): April 15, 2025

Study Record Updates

• Last Update Posted (Actual): April 15, 2025
• Last Update Submitted That Met QC Criteria: April 8, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease; Congenital Abnormalities; Abnormalities, Multiple; Syndrome; Prune Belly Syndrome
• Other Study ID Numbers: 2017/01/01GCZD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No