Impact Evaluation of Incisional Hernia on Muscular and Postural Function
IHMPF-1
Incisional Hernia Impact on Muscular and Postural Function
1 other identifier
interventional
95
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2018
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 2, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
May 15, 2023
CompletedFirst Submitted
Initial submission to the registry
July 22, 2023
CompletedFirst Posted
Study publicly available on registry
August 14, 2023
CompletedAugust 14, 2023
August 1, 2023
5 years
July 22, 2023
August 6, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Diagnostic accuracy
Sensitivity and specificity
1-2 weeks before surgical treatment and 6 months after reconstructive hernioplasty of postoperative ventral hernia
Study Arms (3)
Group I
ACTIVE COMPARATOR32 patients who underwent classic abdominal wall anterior components separation and bridged hernia repair.
Group II
ACTIVE COMPARATOR34 patients who underwent posterior components separation with the internal oblique myofascial release by Rives-Stoppa
Group III
ACTIVE COMPARATOR29 patients who underwent posterior components separation with transversus abdominis release (TAR).
Interventions
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.
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.
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.
Eligibility Criteria
You may qualify if:
- big and giant incisional hernia
- hernia without recurrence
- age 18-75
You may not qualify if:
- acute infection diseases
- cancer
- orthopedic diseases
- terminal status
- BMI\>39,9
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Republican specialized scientific practical medical center of surgery named after V.V. Vakhidov
Tashkent, 100100, Uzbekistan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Otabek J. Eshonkhodjaev, MD, PhD
Republican specialiazed scientific practical medical center of surgery named after V.V. Vakhidov
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal investigator
Study Record Dates
First Submitted
July 22, 2023
First Posted
August 14, 2023
Study Start
January 2, 2018
Primary Completion
December 31, 2022
Study Completion
May 15, 2023
Last Updated
August 14, 2023
Record last verified: 2023-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR