Incisional HerniaIHMPF-1NCT05990647
Impact Evaluation of Incisional Hernia on Muscular and Postural Function
A study testing Dynamometric tension assessment, Postural balance and Assessment of the hernia defect size in people with Incisional Hernia, run by Republican Specialized Scientific and Practical Medical Center of Surgery Named After V. Vakhidov at 1 site in Uzbekistan.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Incisional Hernia
- What is being tested?
- Dynamometric tension assessment, Postural balance and Assessment of the hernia defect size
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 1 siteUzbekistan
- Study dates
- 2 Jan 2018to 15 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- big and giant incisional hernia
- hernia without recurrence
- age 18-75
Who cannot join
- acute infection diseases
- cancer
- orthopedic diseases
- terminal status
- BMI>39,9
Trial locations and contacts
1 site in 1 country.
Uzbekistan1 site
Republican specialized scientific practical medical center of surgery named after V.V. Vakhidov
Tashkent, 100100
About this study
Official title: Incisional Hernia Impact on Muscular and Postural Function
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.
- Conditions
- Incisional Hernia
- Being tested
- Dynamometric tension assessment, Postural balance, Assessment of the hernia defect size, Physical activity of patients
- Keywords
- incisional hernia, tension dynamometry, raster photostereography, postural balance, hernia repair, bridging technique, Rives-Stoppa, TAR
- Medical subject headings
- Incisional Hernia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dynamometric tension assessmentDiagnostic test
Also called DT
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 balanceDiagnostic test
Also called PB
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 sizeDiagnostic test
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 patientsDiagnostic test
Also called PAP
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.
| Study group | Role | What they receive |
|---|---|---|
| Group I | Active comparator | 32 patients who underwent classic abdominal wall anterior components separation and bridged hernia repair. Receives: Diagnostic Test: Dynamometric tension assessment; Diagnostic Test: Postural balance; Diagnostic Test: Assessment of the hernia defect size; Diagnostic Test: Physical activity of patients |
| Group II | Active comparator | 34 patients who underwent posterior components separation with the internal oblique myofascial release by Rives-Stoppa Receives: Diagnostic Test: Dynamometric tension assessment; Diagnostic Test: Postural balance; Diagnostic Test: Assessment of the hernia defect size; Diagnostic Test: Physical activity of patients |
| Group III | Active comparator | 29 patients who underwent posterior components separation with transversus abdominis release (TAR). Receives: Diagnostic Test: Dynamometric tension assessment; Diagnostic Test: Postural balance; Diagnostic Test: Assessment of the hernia defect size; Diagnostic Test: Physical activity of patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy
Sensitivity and specificity
Measured: 1-2 weeks before surgical treatment and 6 months after reconstructive hernioplasty of postoperative ventral hernia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start2 Jan 2018
- Primary completion31 Dec 2022
- Study completion15 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Incisional HerniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Cohort study
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Republican Specialized Scientific and Practical Medical Center of Surgery Named After V. Vakhidov
- Sponsor type
- University, hospital or other
- Collaborators
- Tashkent state dental institute, I.M. Sechenov First Moscow State Medical University, Pirogov Russian National Research Medical University
- Responsible party
- Principal investigator, Nikita A. Demin, Republican Specialized Scientific and Practical Medical Center of Surgery Named After V. Vakhidov
- Investigators
- Otabek J. Eshonkhodjaev, MD, PhD, Study chair, Republican specialiazed scientific practical medical center of surgery named after V.V. Vakhidov
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05990647
- Sponsor's protocol ID
- "EC" №1-2022
- Acronym
- IHMPF-1
- Status last verified
- Aug 2023
- First submitted
- 22 Jul 2023
- Last updated
- 14 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incisional Hernia Impact on Muscular and Postural Function
- ClinicalTrials.gov ID
- NCT05990647
- Acronym / sponsor ID
- IHMPF-1 / "EC" №1-2022
- Conditions
- Incisional Hernia
- Keywords
- incisional hernia, tension dynamometry, raster photostereography, postural balance, hernia repair, bridging technique, Rives-Stoppa, TAR
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Republican Specialized Scientific and Practical Medical Center of Surgery Named After V. VakhidovUniversity, hospital or other
- Collaborators
- Tashkent state dental institute, I.M. Sechenov First Moscow State Medical University, Pirogov Russian National Research Medical University
- Study start
- 2 Jan 2018 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 15 May 2023 (actual)
- First posted
- 14 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
- Model description
- Cohort study
| Arm | Type | Receives |
|---|---|---|
| Group I | Active comparator | Diagnostic Test: Dynamometric tension assessment, Diagnostic Test: Postural balance, Diagnostic Test: Assessment of the hernia defect size, Diagnostic Test: Physical activity of patients32 patients who underwent classic abdominal wall anterior components separation and bridged hernia repair. |
| Group II | Active comparator | Diagnostic Test: Dynamometric tension assessment, Diagnostic Test: Postural balance, Diagnostic Test: Assessment of the hernia defect size, Diagnostic Test: Physical activity of patients34 patients who underwent posterior components separation with the internal oblique myofascial release by Rives-Stoppa |
| Group III | Active comparator | Diagnostic Test: Dynamometric tension assessment, Diagnostic Test: Postural balance, Diagnostic Test: Assessment of the hernia defect size, Diagnostic Test: Physical activity of patients29 patients who underwent posterior components separation with transversus abdominis release (TAR). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- big and giant incisional hernia
- hernia without recurrence
- age 18-75
Key exclusion criteria (5 listed)
- acute infection diseases
- cancer
- orthopedic diseases
- terminal status
- BMI>39,9
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dynamometric tension assessmentAlso: DTTension 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 test | Group I, Group II, Group III |
| Postural balanceAlso: PBPostural 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 test | Group I, Group II, Group III |
| Assessment of the hernia defect sizeParameters 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 | Group I, Group II, Group III |
| Physical activity of patientsAlso: PAPTo 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. | Diagnostic test | Group I, Group II, Group III |
Primary outcome
Diagnostic accuracy
Time frame: 1-2 weeks before surgical treatment and 6 months after reconstructive hernioplasty of postoperative ventral hernia
Sensitivity and specificity
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2023.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Otabek J. Eshonkhodjaev, MD, PhD study chair
Republican specialiazed scientific practical medical center of surgery named after V.V. Vakhidov
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dynamometric tension assessment, Postural balance and Assessment of the hernia defect size in people with Incisional Hernia, run by Republican Specialized Scientific and Practical Medical Center of Surgery Named After V. Vakhidov at 1 site in Uzbekistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Uzbekistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic accuracy (time frame: 1-2 weeks before surgical treatment and 6 months after reconstructive hernioplasty of postoperative ventral hernia). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2023.