IHMPF-1: Impact Evaluation of Incisional Hernia on Muscular and Postural Function
Sponsor
Republican Specialized Scientific and Practical Medical Center of Surgery Named After V. Vakhidov (Other)
Overall Status
Completed
CT.gov ID
NCT05990647
Collaborator
Tashkent state dental institute (Other), I.M. Sechenov First Moscow State Medical University (Other), Pirogov Russian National Research Medical University (Other)
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Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Study Type:
Interventional
Actual Enrollment
:
95 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Cohort studyCohort study
Masking:
Single (Investigator)
Primary Purpose:
Diagnostic
Official Title:
Incisional Hernia Impact on Muscular and Postural Function
Actual Study Start Date
:
Jan 2, 2018
Actual Primary Completion Date
:
Dec 31, 2022
Actual Study Completion Date
:
May 15, 2023
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Group I 32 patients who underwent classic abdominal wall anterior components separation and bridged hernia repair. |
Diagnostic Test: Dynamometric tension assessment
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:
Diagnostic Test: Postural balance
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:
Diagnostic Test: Assessment of the hernia defect size
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)
Diagnostic Test: Physical activity of patients
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 |
Diagnostic Test: Dynamometric tension assessment
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:
Diagnostic Test: Postural balance
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:
Diagnostic Test: Assessment of the hernia defect size
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)
Diagnostic Test: Physical activity of patients
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). |
Diagnostic Test: Dynamometric tension assessment
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:
Diagnostic Test: Postural balance
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:
Diagnostic Test: Assessment of the hernia defect size
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)
Diagnostic Test: Physical activity of patients
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:
|
Outcome Measures
Primary Outcome Measures
- Diagnostic accuracy [1-2 weeks before surgical treatment and 6 months after reconstructive hernioplasty of postoperative ventral hernia]
Sensitivity and specificity
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Republican specialized scientific practical medical center of surgery named after V.V. Vakhidov | Tashkent | Uzbekistan | 100100 |
Sponsors and Collaborators
- Republican Specialized Scientific and Practical Medical Center of Surgery Named After V. Vakhidov
- Tashkent state dental institute
- I.M. Sechenov First Moscow State Medical University
- Pirogov Russian National Research Medical University
Investigators
- Study Chair: Otabek J. Eshonkhodjaev, MD, PhD, Republican specialiazed scientific practical medical center of surgery named after V.V. Vakhidov
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Nikita A. Demin,
Principal investigator,
Republican Specialized Scientific and Practical Medical Center of Surgery Named After V. Vakhidov
ClinicalTrials.gov Identifier:
NCT05990647
Other Study ID Numbers:
- "EC" №1-2022
First Posted:
Aug 14, 2023
Last Update Posted:
Aug 14, 2023
Last Verified:
Aug 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Nikita A. Demin,
Principal investigator,
Republican Specialized Scientific and Practical Medical Center of Surgery Named After V. Vakhidov
Additional relevant MeSH terms: