Optimization of Surgical Treatment of Patients With Incisional Ventral Hernias
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ClinicalTrials.gov Identifier: NCT05734222 |
Recruitment Status :
Recruiting
First Posted : February 17, 2023
Last Update Posted : February 17, 2023
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The goal of our work of optimization of the treatment of postoperative hernias is to improve the results of treatment of patients with median and median-lateral postoperative hernias of medium (W2) and large (W3) sizes by developing new surgical techniques. The main questions it aims to answer are:
- To study the topographic and variant anatomy of vessels and nerves in the retromuscular, preperitoneal, postperitoneal and pre-abdominal cell spaces of the anterior abdominal wall. To determine the most probable sources of blood flow and lymph from the anatomical formations forming the bed of the endoprosthesis.
- To develop technical, surgical techniques that allow to form an implant bed with minimal traumatization of blood vessels and nerves and reduce the risk of postoperative complications.
- To develop a technique for plasty of the anterior abdominal wall in mid-lateral postoperative hernias with a combination of retromuscular and subaponeurotic spaces.
The researchers will compare an experimental group in which a new method of preparing the implant place will be used and a control group in which standard methods of treating postoperative ventral hernias were used to see whether the new method affects the improvement of the postoperative period and the reduction of complications.
Condition or disease | Intervention/treatment | Phase |
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Incisional Hernia Medial Hernia Medial-lateral Hernia | Procedure: A new method of repair of the abdominal wall of mid-lateral postoperative ventral hernias | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 110 participants |
Allocation: | Non-Randomized |
Intervention Model: | Crossover Assignment |
Intervention Model Description: | The study will include patients with postoperative ventral hernias of median and lateral localization and an average hernial gate width from 4.1 to 15 cm (W2-W3 according to the EHS classification).. The size of the hernial gate is determined by CT. The estimated number of patients is 60-80. 25-30 patients with median-lateral ventral postoperative hernias and 35-50 patients with median hernias are expected. 2. The control group is retrospective. It will include patients who have been operated on for POVG in the surgical department No. 1 of the KPH during the last 3 years (25-35) and 5-10 patients who will be operated on within the next 6-8 months. 3. The established group - patients who will be operated on in the surgical department No. 1 of the KPH over the next 1.5 - 2 years, using the developed techniques. |
Masking: | None (Open Label) |
Masking Description: | 4. The comparison groups will include patients who underwent retromuscular plastic surgery followed by aspiration drainage of the prosthesis bed. When analyzing the results, the presence of obesity and coagulopathy will be taken into account, CT and ultrasound examination will be carried out. Special attention will be paid to the presence and volume of liquid formations in the implant bed. 5. Immediate results will be evaluated up to 1 year Criteria for evaluating immediate results: treatment time, pain syndrome, the presence of seromas and hematomas, their infection and suppuration. 6. Long-term results will be evaluated in terms from 1 to 1.5 years. Evaluation criteria: the presence of recurrent hernia, the presence of late complications - fistulas, seromas requiring drainage, pain syndrome. |
Primary Purpose: | Treatment |
Official Title: | Optimization of Surgical Treatment of Patients With Postoperative Median and Median-lateral Ventral Hernias |
Actual Study Start Date : | September 29, 2022 |
Estimated Primary Completion Date : | April 30, 2024 |
Estimated Study Completion Date : | May 23, 2025 |
Arm | Intervention/treatment |
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Active Comparator: Control Group
The control group is retrospective. It will include patients who have been operated on for POVG in the surgical department No. 1 of the KPH during the last 3 years (25-35) and 5-10 patients who will be operated on within the next 6-8 months.
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Procedure: A new method of repair of the abdominal wall of mid-lateral postoperative ventral hernias
Other Name: Development of techniques to minimize traumatization of the neurovascular bundles of the abdominal wall and reduce postoperative complications. |
Experimental: Established group
The established group - patients who will be operated on in the surgical department No. 1 of the KPH over the next 1.5 - 2 years, using the developed techniques.
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Procedure: A new method of repair of the abdominal wall of mid-lateral postoperative ventral hernias
Other Name: Development of techniques to minimize traumatization of the neurovascular bundles of the abdominal wall and reduce postoperative complications. |
- seroma [ Time Frame: from 3 to 5 days ]development of seroma in postoperative area
- hematoma [ Time Frame: from 3 to 5 days ]development of hematoma in postoperative area
- Pus [ Time Frame: from 3 to 7 days ]development of suppuration in postoperative area
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Ages Eligible for Study: | 25 Years to 88 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- The study will include patients with postoperative ventral hernias of median and lateral localization and an average hernial gate width from 4.1 to 15 cm (W2-W3 according to the EHS classification).. The size of the hernial gate is determined by CT.
Exclusion Criteria:
- Patients without postoperative ventral hernias median and lateral localization
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05734222
Contact: Alexander Grigiryevich | +79272024050 | a.g.sonis@samsmu.ru | |
Contact: Vladislav Vladimirovich | +79270004150 | v.v.timoschuk@samsmu.ru |
Russian Federation | |
Clinics of Samara State Medical University | Recruiting |
Samara, Russian Federation |
Responsible Party: | Samara State Medical University |
ClinicalTrials.gov Identifier: | NCT05734222 |
Other Study ID Numbers: |
124537 |
First Posted: | February 17, 2023 Key Record Dates |
Last Update Posted: | February 17, 2023 |
Last Verified: | January 2023 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Incisional Hernia median median-lateral |
median-lateral Incisional hernia hernia Incisional |
Hernia Incisional Hernia Hernia, Ventral Pathological Conditions, Anatomical |
Postoperative Complications Pathologic Processes Hernia, Abdominal |