Actively Recruiting

Phase Not Applicable
Age: 25Years - 88Years
All Genders
ID05734222

Optimization of Surgical Treatment of Patients With Postoperative Median and Median-lateral Ventral Hernias

Led by Samara State Medical University · Updated on 2025-01-01

110

Participants Needed

1

Research Sites

3 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying surgical treatments for patients with postoperative ventral hernias located in the middle and side areas of the abdomen. The focus is on medium and large hernias (classified as W2 and W3) and aims to improve treatment outcomes by developing new surgical techniques. The study will explore the anatomy of blood vessels and nerves in different layers of the abdominal wall to reduce complications and improve recovery. The study compares two groups: a control group who received standard treatment methods for incisional ventral hernias and an experimental group treated with newly developed surgical techniques. These new methods focus on preserving important blood vessels and nerves while creating the implant bed, including a novel approach for repairing mid-lateral hernias by combining retromuscular and subaponeurotic spaces. The clinical phase includes up to 80 patients, with treatments performed over 1.5 to 2 years. Participants will undergo assessments before and after surgery, including CT scans and ultrasound to evaluate blood supply and fluid accumulation in the implant area. Researchers will monitor immediate results for up to one year, tracking treatment time, pain, seromas, hematomas, infections, and complications. Long-term follow-up of 1 to 1.5 years will assess hernia recurrence and late complications such as fistulas or persistent pain. Data will be analyzed using advanced statistical methods to evaluate the effectiveness and safety of the new surgical techniques.

CONDITIONS

Brief Title

Optimization of Surgical Treatment of Patients With Incisional Ventral Hernias

Who Can Participate

Age: 25Years - 88Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with postoperative ventral hernias located in the median or lateral parts of the abdomen
  • Hernias with an average gate width from 4.1 to 15 cm (W2-W3 according to EHS classification)
  • Hernia size confirmed by CT scan
  • Adults aged 25 to 88 years
Not Eligible

You will not qualify if you...

  • Patients without postoperative ventral hernias of median or lateral localization

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery and Immediate Post-operative Care

Duration - Up to 5 days

Participants undergo surgery using new surgical techniques to repair mid-lateral postoperative ventral hernias with minimal traumatization of neurovascular bundles. Immediate post-operative care focuses on monitoring for complications such as bleeding, hematoma, and seroma formation.

Daily visits for up to 5 days

Post-operative Follow-up

Duration - Up to 1 year

Participants are monitored for postoperative complications including pus formation and persisting pain. Follow-up includes evaluation of treatment effectiveness and detection of any complications over the first year after surgery.

Regular follow-up visits over 1 year

Trial Site Locations

Total: 1 location

1

Clinics of Samara State Medical University

Samara, Russia

Actively Recruiting

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Research Team

A

Alexander Sonis, doctor

V

Vladislav Timoschuk, PhD student

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

CROSSOVER

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Transversus abdominis muscle release: a novel approach to posterior component separation during complex abdominal wall reconstruction.

Yuri W Novitsky, Heidi L Elliott, Sean B Orenstein...

https://pubmed.ncbi.nlm.nih.gov/22607741