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OpenTrials
Active, Not Recruiting

NCT Number: NCT06928974

Functional Abdominal Wall Reconstruction

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Prune Belly Syndrome Abnormalities, Multiple Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Maria Sklodowska Curie Memorial National Cancer Center

Gliwice, Poland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

Bilateral Pedicled Vastus Lateralis Muscle Flaps Transposition

Procedure

Bilateral Pedicled Vastus Lateralis Muscle Flaps Transposition to restore the function of underdeveloped or absent rectus abdomini muscles

Primary outcomes

  1. Electromyography

    Time frame: followup reached 96months

    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.

  2. Motor tests - performance of ''sit-up''-like movement

    Time frame: Followup reached 96 months

    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

Sponsors and collaborators

Lead sponsor

Maria Sklodowska-Curie National Research Institute of Oncology

Other

Collaborators

  • Górnośląskie Centrum Zdrowia Dziecka

Registry information

Official study title

Functional Abdominal Wall Reconstruction in Patients With Prune Belly Syndrome

Important dates

Study start
2017
Primary completion
2024
Study completion
2026
First posted
Apr 15, 2025
Registry last updated
Apr 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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