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Completed

NCT Number: NCT05990647

Impact Evaluation of Incisional Hernia on Muscular and Postural Function

Purpose of study is to assess perioperative functional parameters of the anterior abdominal wall muscles and postural control status in patients with large and giant incisional hernias in a controlled diagnostic study.

The study involved 95 patients (100% completed) with a large or giant incisional hernia of the anterior abdominal wall. The participants were divided into three groups by type of hernia repair: bridged hernia repair, Rives-Stoppa procedure, or TAR technique. Perioperative functional parameters of the anterior abdominal wall muscles were assessed by tension dynamometry. The postural balance assessments were made by raster photostereography.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Republican specialized scientific practical medical center of surgery named after V.V. Vakhidov

Tashkent, 100100, Uzbekistan

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • big and giant incisional hernia
  • hernia without recurrence
  • age 18-75

Exclusion criteria

  • acute infection diseases
  • cancer
  • orthopedic diseases
  • terminal status
  • BMI>39,9

Treatment and study plan

Dynamometric tension assessment

Diagnostic Test

Tension dynamometry was carried out using the "Back-Check 600" diagnostic complex by Dr.WOLFF® (GmbH, Germany). The dynamometric stress assessment included tasks for flexion and extension of the body. The functional assessment of the abdominal wall muscles was assessed when preparing the patient for surgery (1-10 days before AWR-abdominal wall reconstruction) and 6 months after AWR.

Other names: DT

Postural balance

Diagnostic Test

Postural balance was assessed using raster photostereography and baropodometry on the "DIERS" diagnostic complex by Formetric-4D (GmbH, Germany). When analyzing the topography of the optical field, muscle imbalance is revealed in the form of lateral deviation and inclination of the trunk and pelvis, as well as the values of the angle of kyphosis and lordosis. When conducting baropodometry, the level of displacement of the pressure area on the feet of patients in a static and dynamic position was assessed. Diagnosis of postural balance in patients with incisional ventral hernia was performed a few days before surgical treatment and 6 months after AWR.

Other names: PB

Assessment of the hernia defect size

Diagnostic Test

Parameters of the hernial defect, including the volume of the hernial sac, the diameter of the hernial orifice, the ratio of hernia volume to the abdominal cavity volume, were performed using preoperative (1-10 days before AWR) multispiral computed tomography on a GE "BrightSpeed 16" tomograph (General Electric©, USA)

Physical activity of patients

Diagnostic Test

To analyze the physical activity of patients, the measurement of the number of steps was used. The measurements of steps and the amount of distance traveled were carried out using a physical activity monitor - a fitness bracelet "MiBAND" (China). Measurements were taken 10 days before AWR and within 6 months after AWR.

Other names: PAP

Primary outcomes

  1. Diagnostic accuracy

    Time frame: 1-2 weeks before surgical treatment and 6 months after reconstructive hernioplasty of postoperative ventral hernia

    Sensitivity and specificity

Sponsors and collaborators

Lead sponsor

Republican Specialized Scientific and Practical Medical Center of Surgery Named After V. Vakhidov

Other

Collaborators

  • I.M. Sechenov First Moscow State Medical University
  • Pirogov Russian National Research Medical University
  • Tashkent state dental institute

Registry information

Official study title

Incisional Hernia Impact on Muscular and Postural Function

Acronym: IHMPF-1

Important dates

Study start
2018
Primary completion
2022
Study completion
2023
First posted
Aug 14, 2023
Registry last updated
Aug 14, 2023

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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