- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05990647
Impact Evaluation of Incisional Hernia on Muscular and Postural Function (IHMPF-1)
Incisional Hernia Impact 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.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Tashkent, Uzbekistan, 100100
- Republican specialized scientific practical medical center of surgery named after V.V. Vakhidov
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Group I
32 patients who underwent classic abdominal wall anterior components separation and bridged hernia repair.
|
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:
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:
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)
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:
|
Active Comparator: Group II
34 patients who underwent posterior components separation with the internal oblique myofascial release by Rives-Stoppa
|
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:
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:
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)
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:
|
Active Comparator: Group III
29 patients who underwent posterior components separation with transversus abdominis release (TAR).
|
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:
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:
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)
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:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Diagnostic accuracy
Time Frame: 1-2 weeks before surgical treatment and 6 months after reconstructive hernioplasty of postoperative ventral hernia
|
Sensitivity and specificity
|
1-2 weeks before surgical treatment and 6 months after reconstructive hernioplasty of postoperative ventral hernia
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Otabek J. Eshonkhodjaev, MD, PhD, Republican specialiazed scientific practical medical center of surgery named after V.V. Vakhidov
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- "EC" №1-2022
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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