RecruitingNCT05920200Updated Jul 23, 2024

Factors Influencing the Results of Treatment in Patients With Hernias of Various Localizations

An observational study in Inguinal Hernia, Femoral Hernia and Umbilical Hernia, sponsored by Immanuel Kant Baltic Federal University. Recruiting at 1 site in Russian Federation. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2024-07-23.

Sponsored by Immanuel Kant Baltic Federal University · Observational

From the registry’s dates

Primary completion was expected by Dec 2025, 10 months ago, but the record still lists the study as recruiting.
Started Jan 2020; still recruiting 6 years 10 months later.

Study type: Observational
Model: Cohort
Time perspective: Prospective
Enrollment: 4,000
Ages: 18 Years to 90 Years
Sex: All

Study 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.

For this purpose the investigators will analyze data from the Kalinigrad Hernia Registry (KHR).

Conditions studied

Inguinal Hernia
Femoral Hernia
Umbilical Hernia
Ventral Hernia
Chronic Pain
Acute Post Operative Pain
Recrrence Rate

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Keywords

hernia
register
inguinal hernia
femoral hernia
umbilical hernia
ventral hernia
CPIP
postoperative complications
chronic post-operative pain
recurrence rate

In context

Hernia, Inguinal

543 studies on the registry are indexed under Hernia, Inguinal; 92 are open to participants now.

This study's planned enrollment of 4,000 is above the median of 134 across 137 observational studies indexed under Hernia, Inguinal.

Browse Hernia, Inguinal studies →

Lead sponsor

Immanuel Kant Baltic Federal University is the lead sponsor of 2 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 90 Years
Sexes eligible: All
Accepts healthy volunteers: No
Sampling method: Non-probability sample

Study population

An unselected, consecutive regionwide cohort during 3 years, with a 3-year follow-up

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

All mesh and non-mesh repairs that have been registered in the KHR from January 9, 2020, until December 31, 2023.

Exclusion criteria

Exclusion Criteria:

Patients not having a 11-digit state-assigned Personal insurance policy number.
Parastomal hernia;
infected hernias;

Study design

Observational model: Cohort
Time perspective: Prospective
Enrollment: 4,000 participants (estimated)
Patient registry: No

Groups and cohorts

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

Interventions

Procedureopen non-mesh hernia repair
A groin and femoral hernia non-mesh repair. An umbilical hernia non-mesh repair. A ventral and incisional hernia non-mesh repair.
Procedureopen mesh hernia repair
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.
ProcedureMIS hernia repair
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 .

What researchers measure

Primary outcomes

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%).
Time frame: 1 year
Recurrence rate
the overall frequency of recurrent hernias
Time frame: 3 year

Secondary outcomes

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.
Time frame: 3 year

Study locations

1 of 1 sites recruiting

Baltic Federal University
Kaliningrad, Kaliningrad Region 236041, Russian Federation
1 other open study at this site →
Recruiting
- Viktor V Kakotkin, MD · Contact · Vkakotkin@kantiana.ru · +74012595071
- Mikhail A Agapov, PhD/MD · Principal investigator
- Viktor V Kakotkin, MD · Sub investigator
Recruiting

References and documents

Individual participant data

Plan to share: No — No individual participant data (IPD) will be available for other researcher.

No publications or documents are linked to this record.

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jan 2020 (actual). Primary completion is estimated for Dec 2025, 71 months after the start.

Of 51 non-industry observational studies under Hernia, Inguinal, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 68. This study's planned 71 months is above that.

Counting every sponsor, half of 57 studies reached it within 18 months; a quarter within 9 and three quarters within 68.

How these figures are worked out, and which studies are left out of them.

Registered: Jun 6, 2023
First posted: Jun 27, 2023
StartActual: Jan 9, 2020
Primary completionEst.: Dec 31, 2025
CompletionEst.: Dec 31, 2025
Last update: Jul 23, 2024

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Jul 23, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT05920200
Lead sponsor: Immanuel Kant Baltic Federal University
Responsible party: Sponsor
First posted: Jun 27, 2023
Start date: Jan 9, 2020
Primary completion: Dec 31, 2025 (estimated)
Completion: Dec 31, 2025 (estimated)
Last update: Jul 23, 2024

Study contacts

Viktor V Kakotkin, MD

Contact

Vkakotkin@kantiana.ru

+74012595071

Oversight

Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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