Optimization of Surgical Treatment of Patients With Incisional Ventral Hernias

NCT05734222 | Recruiting DMC

• 1 other identifier: 124537
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

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:

1. 1.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.
2. 2.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.
3. 3.To develop a technique for plasty of the anterior abdominal wall in mid-lateral postoperative hernias with a combination of retromuscular and subaponeurotic spaces.

Conditions

Hernia, Ventral; Hernias Intestinal; Hernia Abdominal Wall

Keywords

Hernia; median; median-lateral; median-lateral Incisional hernia; Incisional

Outcome Measures

Primary Outcomes (3)

• rate of seroma

  rate of development of seroma in postoperative area

  5 days

• rate of hematoma

  rate of development of hematoma in postoperative area

  5 days

• Recurrence rate

  Rate of hernia recurrences diagnosed at clinical and/or ultrasound examination

  One year

Secondary Outcomes (2)

• Pus

  7 days

• Persisting postoperative pain

  one year

Study Arms (2)

Control Group

ACTIVE COMPARATOR

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.

Procedure: A new method of repair of the abdominal wall of mid-lateral postoperative ventral hernias

Established group

EXPERIMENTAL

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.

Procedure: A new method of repair of the abdominal wall of mid-lateral postoperative ventral hernias

Interventions

A new method of repair of the abdominal wall of mid-lateral postoperative ventral hernias PROCEDURE

1. It is planned to study potential sources of bleeding and hematoma formation during SRM plastic surgery. On this basis, recommendations on the technique of the operation will be formulated. 2. It is supposed to find a way to preserve intercostal neurovascular bundles when performing SRM repair. This should improve the quality of abdominal wall reconstruction by preserving neurovascular bundles of muscles and reducing neuroalgic pain syndrome. 3. It is proposed to develop a method for combining retromuscular and subaponeurotic spaces in the treatment of mid-lateral hernias 4. It is planned to substantiate the effectiveness and expediency of the application of the developed surgical techniques based on the analysis of the immediate and long-term results of treatment.

Also known as: Development of techniques to minimize traumatization of the neurovascular bundles of the abdominal wall and reduce postoperative complications.

Control Group; Established group

Eligibility Criteria

• Age: 25 Years - 88 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients without postoperative ventral hernias median and lateral localization

Sponsors & Collaborators

• Samara State Medical University: lead

Study Sites (1)

Clinics of Samara State Medical University

Samara, Russia

RECRUITING

Related Publications (10)

• Novitsky YW, Elliott HL, Orenstein SB, Rosen MJ. Transversus abdominis muscle release: a novel approach to posterior component separation during complex abdominal wall reconstruction. Am J Surg. 2012 Nov;204(5):709-16. doi: 10.1016/j.amjsurg.2012.02.008. Epub 2012 May 16.

  PMID: 22607741 RESULT

• Nielsen MF, de Beaux A, Stutchfield B, Kung J, Wigmore SJ, Tulloh B. Peritoneal flap hernioplasty for repair of incisional hernias after orthotopic liver transplantation. Hernia. 2022 Apr;26(2):481-487. doi: 10.1007/s10029-021-02409-5. Epub 2021 Apr 22.

  PMID: 33884521 RESULT

• Nielsen MF, de Beaux A, Damaskos D, Tulloh B. Peritoneal flap hernioplasty for reconstruction of transverse incisional hernias. Hernia. 2021 Apr;25(2):313-319. doi: 10.1007/s10029-019-02099-0. Epub 2019 Dec 7.

  PMID: 31813114 RESULT

• Kostov S, Dineva S, Kornovski Y, Slavchev S, Ivanova Y, Yordanov A. Vascular Anatomy and Variations of the Anterior Abdominal Wall - Significance in Abdominal Surgery. Prague Med Rep. 2023;124(2):108-142. doi: 10.14712/23362936.2023.9.

  PMID: 37212131 RESULT

• Oprea V, Radu VG, Moga D; -. Transversus Abdominis Muscle Release (TAR) for Large Incisional Hernia Repair. Chirurgia (Bucur). 2016 Nov-Dec;111(6):535-540. doi: 10.21614/chirurgia.111.6.535.

  PMID: 28044960 RESULT

• Клинические рекомендации "Послеоперационная вентральная грыжа", 2021-2022-2023 (23.10.2021) - Утверждены Минздравом РФ, ID 685 Doi 10.7602/jmis.2018.21.1.5

  RESULT

• Диссертационное исследование Гуляев М.Г. "Профилактика и лечение рецидивных вен-тральных грыж после аутопластических и протезирующих вмешательств" 2015г/ Doi 10.17116/hirurgia201910136

  RESULT

• Belokonev Vladimir, Sergey Pushkin, Zinaida Kovaleva, Yuliya Ponomareva, and Maksim Gulyaev. Etiology, Pathogenesis and Treatment of Recurrent Postoperative Ventral Hernias. INFRA-M Academic Publishing LLC., 2021. https://doi.org/10.12737/1058965.

  RESULT

• Мадьяров, В.М., Р.Б. Турсунов, С.П. Мухаметова, and М.Е. Кусманов. "Prevention of the risk of postoperative ventral hernias with open surgical interventions on the anterior ab-dominal wall." Vestnik, no. 4 (February 25, 2022): 98-104. https://doi.org/10.53065/kaznmu.2021.45.79.019.

  RESULT

• Мишкин, И., I. Mishkin, Н. Садыкова, and N. Sadykova. "Comparative characteristics of tension free techniques hernioplasty in the treatment of ventral hernias." Clinical Medicine and Pharmacology 4, no. 2 (July 27, 2018): 27-30. https://doi.org/10.12737/article_5b5ade394350a0.50327344.

  RESULT

MeSH Terms

Conditions

Hernia, Ventral; Hernia, Abdominal; Hernia; Surgical Wound

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Wounds and Injuries

Study Officials

• Vladislav Timoschuk, Phd Student

  Samara State Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexander Sonis, doctor

CONTACT

+79272024050; a.g.sonis@samsmu.ru

Vladislav Timoschuk, PhD student

CONTACT

+79270004150; v.v.timotshuk1@samsmu.ru

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 8, 2023
• First Posted: February 17, 2023
• Study Start: September 29, 2022
• Primary Completion: April 30, 2025
• Study Completion: May 23, 2025
• Last Updated: January 1, 2025

Record last verified: 2024-12

Locations

RU (1)