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Impact Evaluation of Incisional Hernia on Muscular and Postural Function

Incisional Hernia Impact on Muscular and Postural Function

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05990647
Acronym
IHMPF-1
Enrollment
95
Registered
2023-08-14
Start date
2018-01-02
Completion date
2023-05-15
Last updated
2023-08-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Incisional Hernia

Keywords

incisional hernia, tension dynamometry, raster photostereography, postural balance, hernia repair, bridging technique, Rives-Stoppa, TAR

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.

Interventions

DIAGNOSTIC_TESTDynamometric 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.

DIAGNOSTIC_TESTPostural 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.

DIAGNOSTIC_TESTAssessment 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_TESTPhysical 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.

Sponsors

Tashkent state dental institute
CollaboratorUNKNOWN
I.M. Sechenov First Moscow State Medical University
CollaboratorOTHER
Pirogov Russian National Research Medical University
CollaboratorOTHER
Republican Specialized Scientific and Practical Medical Center of Surgery Named After V. Vakhidov
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Investigator)

Intervention model description

Cohort study

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Diagnostic accuracy1-2 weeks before surgical treatment and 6 months after reconstructive hernioplasty of postoperative ventral herniaSensitivity and specificity

Countries

Uzbekistan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026