Inguinal HerniaNCT05920200
Factors Influencing the Results of Treatment in Patients With Hernias of Various Localizations
An observational study of Inguinal Hernia and Femoral Hernia, run by Immanuel Kant Baltic Federal University at 1 site in Russia.
Trial summary
The study attempts to quantify the relative risks for acute postoperative pain, complications rate, chronic postoperative pain (CPIP) and recurrence rate after different methods of repair of groin, umbilical and incisional hernia depending on surgical technique, mesh type and fixation suture material. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Inguinal Hernia, Femoral Hernia, Umbilical Hernia
- What is being tested?
- open non-mesh hernia repair, open mesh hernia repair and MIS hernia repair
- Type of treatment
- Surgery or procedure
- How many people
- 4,000 participants
- Where
- 1 siteRussia
- Study dates
- 9 Jan 2020to 31 Dec 2025
- Phase
- Observational
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: An unselected, consecutive regionwide cohort during 3 years, with a 3-year follow-up
Who may be able to join
- All mesh and non-mesh repairs that have been registered in the KHR from January 9, 2020, until December 31, 2023.
Who cannot join
- Patients not having a 11-digit state-assigned Personal insurance policy number.
- Parastomal hernia;
- infected hernias;
Trial locations and contacts
1 site in 1 country.
Russia1 site, 1 recruiting
- Recruiting
Baltic Federal University
Kaliningrad, Kaliningrad Oblast, 236041
Viktor V Kakotkin, MD, +74012595071, Vkakotkin@kantiana.ru
Mikhail A Agapov, PhD/MD
About this study
Official title: Factors Affecting the Results of Treatment of Patients With Hernias of Various Localization: Evaluation of Treatment Results Using an Automated Hernia Register
The study attempts to quantify the relative risks for acute postoperative pain, complications rate, chronic postoperative pain (CPIP) and recurrence rate after different methods of repair of groin, umbilical and incisional hernia depending on surgical technique, mesh type and fixation suture material.
For this purpose the investigators will analyze data from the Kalinigrad Hernia Registry (KHR).
- Conditions
- Inguinal Hernia, Femoral Hernia, Umbilical Hernia, Ventral Hernia, Chronic Pain, Acute Post Operative Pain
- Being tested
- open non-mesh hernia repair, open mesh hernia repair, MIS hernia repair
- Keywords
- hernia, register, inguinal hernia, femoral hernia, umbilical hernia, ventral hernia, CPIP, postoperative complications, chronic post-operative pain, recurrence rate
- Medical subject headings
- Hernia, Inguinal, Hernia, Femoral, Hernia, Umbilical, Hernia, Ventral, Chronic Pain, Pain, Postoperative, Hernia, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
open non-mesh hernia repairProcedure or surgery
A groin and femoral hernia non-mesh repair. An umbilical hernia non-mesh repair. A ventral and incisional hernia non-mesh repair.
open mesh hernia repairProcedure or surgery
A groin and femoral hernia repair, reinforced by synthetic mesh. The mesh is affixed with sutures for Lichtenstein. Self-fixating mesh is also possible.
An umbilical, ventral, incisional hernia repair, reinforced by synthetic mesh. The mesh is affixed with sutures.
MIS hernia repairProcedure or surgery
A groin and femoral minimal invasive hernia repair (TAPP, eTEP). The mesh is affixed with tack/no-fixation. Self-fixation mesh is also possible.
An umbilical, ventral, incisional minimal invasive hernia repair (eTEP, IPOM,). The mesh is affixed with tack and no-fixation .
| Study group | Role | What they receive |
|---|---|---|
| Patients with groin and femoral hernia/IG | Not described Receives: Procedure: open non-mesh hernia repair; Procedure: open mesh hernia repair; Procedure: MIS hernia repair | |
| Patients with umbilical hernia/IG | Not described Receives: Procedure: open non-mesh hernia repair; Procedure: open mesh hernia repair; Procedure: MIS hernia repair | |
| Patients with ventral and incisional hernia/InG | Not described Receives: Procedure: open non-mesh hernia repair; Procedure: open mesh hernia repair; Procedure: MIS hernia repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chronic postoperative pain rate and severity
The painDETECT questionnaire will be used to identify chronic postoperative pain.
Final painDETECT Score: 20, indicating that a neuropathic pain component is likely (>90%).
Measured: 1 year
Recurrence rate
the overall frequency of recurrent hernias
Measured: 3 year
Secondary outcomes (1)
Treatment satisfaction rate
To assess the quality of life will be used Eura HS Quality of Life Scale-EuraHS QoL.
EuraHS Qol - total (min - 0, max - 90) EuraHS Qol - pain (min - 0, max - 30) EuraHS Qol - restriction of activities (min - 0, max - 40) EuraHS Qol - cosmetic discomfort (min -0, max - 20)
Higher scores mean a worse outcome.
Measured: 3 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2023
- Study start9 Jan 2020
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inguinal 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Immanuel Kant Baltic Federal University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05920200
- Sponsor's protocol ID
- HR202339
- Status last verified
- Jul 2024
- First submitted
- 6 Jun 2023
- Last updated
- 23 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No individual participant data (IPD) will be available for other researcher.
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Factors Affecting the Results of Treatment of Patients With Hernias of Various Localization: Evaluation of Treatment Results Using an Automated Hernia Register
- ClinicalTrials.gov ID
- NCT05920200
- Acronym / sponsor ID
- HR202339
- Conditions
- Inguinal Hernia, Femoral Hernia, Umbilical Hernia, Ventral Hernia, Chronic Pain, Acute Post Operative Pain
- Keywords
- hernia, register, inguinal hernia, femoral hernia, umbilical hernia, ventral hernia, CPIP, postoperative complications
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 4,000 participants (estimated)
- Lead sponsor
- Immanuel Kant Baltic Federal UniversityUniversity, hospital or other
- Study start
- 9 Jan 2020 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 27 Jun 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.
The study attempts to quantify the relative risks for acute postoperative pain, complications rate, chronic postoperative pain (CPIP) and recurrence rate after different methods of repair of groin, umbilical and incisional hernia depending on surgical technique, mesh type and fixation suture material.
For this purpose the investigators will analyze data from the Kalinigrad Hernia Registry (KHR).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients with groin and femoral hernia/IG | – | Procedure: open non-mesh hernia repair, Procedure: open mesh hernia repair, Procedure: MIS hernia repair |
| Patients with umbilical hernia/IG | – | Procedure: open non-mesh hernia repair, Procedure: open mesh hernia repair, Procedure: MIS hernia repair |
| Patients with ventral and incisional hernia/InG | – | Procedure: open non-mesh hernia repair, Procedure: open mesh hernia repair, Procedure: MIS hernia repair |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- An unselected, consecutive regionwide cohort during 3 years, with a 3-year follow-up
Key inclusion criteria (1 listed)
- All mesh and non-mesh repairs that have been registered in the KHR from January 9, 2020, until December 31, 2023.
Key exclusion criteria (3 listed)
- Patients not having a 11-digit state-assigned Personal insurance policy number.
- Parastomal hernia;
- infected hernias;
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 |
|---|---|---|
| open non-mesh hernia repairA groin and femoral hernia non-mesh repair. An umbilical hernia non-mesh repair. A ventral and incisional hernia non-mesh repair. | Procedure or surgery | Patients with groin and femoral hernia/IG, Patients with umbilical hernia/IG, Patients with ventral and incisional hernia/InG |
| open mesh hernia repairA groin and femoral hernia repair, reinforced by synthetic mesh. The mesh is affixed with sutures for Lichtenstein. Self-fixating mesh is also possible. An umbilical, ventral, incisional hernia repair, reinforced by synthetic mesh. The mesh is affixed with sutures. | Procedure or surgery | Patients with groin and femoral hernia/IG, Patients with umbilical hernia/IG, Patients with ventral and incisional hernia/InG |
| MIS hernia repairA groin and femoral minimal invasive hernia repair (TAPP, eTEP). The mesh is affixed with tack/no-fixation. Self-fixation mesh is also possible. An umbilical, ventral, incisional minimal invasive hernia repair (eTEP, IPOM,). The mesh is affixed with tack and no-fixation . | Procedure or surgery | Patients with groin and femoral hernia/IG, Patients with umbilical hernia/IG, Patients with ventral and incisional hernia/InG |
Primary outcome
Chronic postoperative pain rate and severity
Time frame: 1 year
The painDETECT questionnaire will be used to identify chronic postoperative pain. Final painDETECT Score: 20, indicating that a neuropathic pain component is likely (>90%).
Recurrence rate
Time frame: 3 year
the overall frequency of recurrent hernias
1 secondary outcome
Treatment satisfaction rate
Time frame: 3 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2024.
- Individual participant dataSharing planned: No. No individual participant data (IPD) will be available for other researcher.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inguinal Hernia and Femoral Hernia, run by Immanuel Kant Baltic Federal University at 1 site in Russia.
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 1 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 23 Jul 2024. 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 Russia. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Viktor V Kakotkin, MD (+74012595071, Vkakotkin@kantiana.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chronic postoperative pain rate and severity (time frame: 1 year). The study lists 2 primary outcomes in all. 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 23 Jul 2024.