Impact Evaluation of Incisional Hernia on Muscular and Postural Function

Incisional Hernia Clinical Trial

— IHMPF-1  

Official title:

Incisional Hernia Impact on Muscular and Postural Function

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05990647
• Other study ID #: "EC" ?1-2022
• Status: Completed
• Phase: N/A
• Start date: January 2, 2018
• Est. completion date: May 15, 2023

Study information

• Verified date: August 2023
• Source: Republican Specialized Scientific and Practical Medical Center of Surgery Named After V. Vakhidov
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 95
• Est. completion date: May 15, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Hernia
• Incisional Hernia

Intervention

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.
• 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.
• 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)
• 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.

Locations

Country	Name	City	State
Uzbekistan	Republican specialized scientific practical medical center of surgery named after V.V. Vakhidov	Tashkent

Sponsors (4)

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

Country where clinical trial is conducted

Uzbekistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic accuracy	Sensitivity and specificity	1-2 weeks before surgical treatment and 6 months after reconstructive hernioplasty of postoperative ventral hernia