Impact Evaluation of Incisional Hernia on Muscular and Postural Function

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
Incisional Hernia Impact on Muscular and Postural Function

Conditions
-----------------
Incisional Hernia

Intervention / Treatment
-----------------
* Diagnostic Test: Dynamometric tension assessment
* Diagnostic Test: Postural balance
* Diagnostic Test: Assessment of the hernia defect size
* Diagnostic Test: Physical activity of patients


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Cohort study
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group I<br>32 patients who underwent classic abdominal wall anterior components separation and bridged hernia repair. | Diagnostic Test: Dynamometric tension assessment<br>* 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.<br>* Other names: DT;Diagnostic Test: Postural balance<br>* 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.<br>* Other names: PB;Diagnostic Test: Assessment of the hernia defect size<br>* 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)<br>Diagnostic Test: Physical activity of patients<br>* 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.<br>* Other names: PAP;|
| Active Comparator: Group II<br>34 patients who underwent posterior components separation with the internal oblique myofascial release by Rives-Stoppa | Diagnostic Test: Dynamometric tension assessment<br>* 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.<br>* Other names: DT;Diagnostic Test: Postural balance<br>* 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.<br>* Other names: PB;Diagnostic Test: Assessment of the hernia defect size<br>* 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)<br>Diagnostic Test: Physical activity of patients<br>* 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.<br>* Other names: PAP;|
| Active Comparator: Group III<br>29 patients who underwent posterior components separation with transversus abdominis release (TAR). | Diagnostic Test: Dynamometric tension assessment<br>* 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.<br>* Other names: DT;Diagnostic Test: Postural balance<br>* 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.<br>* Other names: PB;Diagnostic Test: Assessment of the hernia defect size<br>* 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)<br>Diagnostic Test: Physical activity of patients<br>* 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.<br>* Other names: PAP;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic accuracy | Sensitivity and specificity | 1-2 weeks before surgical treatment and 6 months after reconstructive hernioplasty of postoperative ventral hernia | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
TAR, incisional hernia, tension dynamometry, raster photostereography, postural balance, hernia repair, bridging technique, Rives-Stoppa