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/22607741Actively Recruiting
Led by Samara State Medical University · Updated on 2025-01-01
110
Participants Needed
1
Research Sites
3 weeks
Total Duration
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
Optimization of Surgical Treatment of Patients With Incisional Ventral Hernias
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Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
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
Total: 1 location
1
Clinics of Samara State Medical University
Samara, Russia
Actively Recruiting
A
Alexander Sonis, doctor
V
Vladislav Timoschuk, PhD student
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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