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Impact Evaluation of Incisional Hernia on Muscular and Postural Function (IHMPF-1)

Primary Purpose

Incisional Hernia

Status
Completed
Phase
Not Applicable
Locations
Uzbekistan
Study Type
Interventional
Intervention
Dynamometric tension assessment
Postural balance
Assessment of the hernia defect size
Physical activity of patients
Sponsored by
Republican Specialized Scientific and Practical Medical Center of Surgery Named After V. Vakhidov
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Incisional Hernia focused on measuring incisional hernia, tension dynamometry, raster photostereography, postural balance, hernia repair, bridging technique, Rives-Stoppa, TAR

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Group I

Group II

Group III

Arm Description

32 patients who underwent classic abdominal wall anterior components separation and bridged hernia repair.

34 patients who underwent posterior components separation with the internal oblique myofascial release by Rives-Stoppa

29 patients who underwent posterior components separation with transversus abdominis release (TAR).

Outcomes

Primary Outcome Measures

Diagnostic accuracy
Sensitivity and specificity

Secondary Outcome Measures

Full Information

First Posted
July 22, 2023
Last Updated
August 6, 2023
Sponsor
Republican Specialized Scientific and Practical Medical Center of Surgery Named After V. Vakhidov
Collaborators
Tashkent state dental institute, I.M. Sechenov First Moscow State Medical University, Pirogov Russian National Research Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT05990647
Brief Title
Impact Evaluation of Incisional Hernia on Muscular and Postural Function
Acronym
IHMPF-1
Official Title
Incisional Hernia Impact on Muscular and Postural Function
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
January 2, 2018 (Actual)
Primary Completion Date
December 31, 2022 (Actual)
Study Completion Date
May 15, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Republican Specialized Scientific and Practical Medical Center of Surgery Named After V. Vakhidov
Collaborators
Tashkent state dental institute, I.M. Sechenov First Moscow State Medical University, Pirogov Russian National Research Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Incisional Hernia
Keywords
incisional hernia, tension dynamometry, raster photostereography, postural balance, hernia repair, bridging technique, Rives-Stoppa, TAR

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Cohort study
Masking
Investigator
Allocation
Randomized
Enrollment
95 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group I
Arm Type
Active Comparator
Arm Description
32 patients who underwent classic abdominal wall anterior components separation and bridged hernia repair.
Arm Title
Group II
Arm Type
Active Comparator
Arm Description
34 patients who underwent posterior components separation with the internal oblique myofascial release by Rives-Stoppa
Arm Title
Group III
Arm Type
Active Comparator
Arm Description
29 patients who underwent posterior components separation with transversus abdominis release (TAR).
Intervention Type
Diagnostic Test
Intervention Name(s)
Dynamometric tension assessment
Other Intervention Name(s)
DT
Intervention Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Postural balance
Other Intervention Name(s)
PB
Intervention Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Assessment of the hernia defect size
Intervention Description
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)
Intervention Type
Diagnostic Test
Intervention Name(s)
Physical activity of patients
Other Intervention Name(s)
PAP
Intervention Description
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.
Primary Outcome Measure Information:
Title
Diagnostic accuracy
Description
Sensitivity and specificity
Time Frame
1-2 weeks before surgical treatment and 6 months after reconstructive hernioplasty of postoperative ventral hernia

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Otabek J. Eshonkhodjaev, MD, PhD
Organizational Affiliation
Republican specialiazed scientific practical medical center of surgery named after V.V. Vakhidov
Official's Role
Study Chair
Facility Information:
Facility Name
Republican specialized scientific practical medical center of surgery named after V.V. Vakhidov
City
Tashkent
ZIP/Postal Code
100100
Country
Uzbekistan

12. IPD Sharing Statement

Plan to Share IPD
Yes

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Impact Evaluation of Incisional Hernia on Muscular and Postural Function

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