Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05734222 |
| Other study ID # |
124537 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
September 29, 2022 |
| Est. completion date |
May 23, 2025 |
Study information
| Verified date |
January 2023 |
| Source |
Samara State Medical University |
| Contact |
Alexander Grigiryevich |
| Phone |
+79272024050 |
| Email |
a.g.sonis[@]samsmu.ru |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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. 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. 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. 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.
Description:
Relevance of the research topic:
The problem of surgical treatment of postoperative ventral hernias (POVG) remains relevant to
the present time. PWS account for 20-22% of the total number of hernias and occupy the second
place in frequency of occurrence after inguinal hernias. Despite the rapid development of
minimally invasive technologies in abdominal surgery, according to various authors, the
frequency of occurrence of POVG after elective operations reaches 4-18.1%, and after urgent
operations - 18.1-58.7% (Ishutov I.V. et al. 2020, 2018, 2016, Krivoshchekov E.P. et al.
2018, Samartsev V.A., Gavrilov V.A. 2018, 2016, Lu. Y, et al 2021).
The use of mesh implants in the treatment of POVH reduced the number of relapses, but led to
an increase in the frequency of postoperative wound complications, reaching, according to
various authors, impressive figures - 20.9-49.2% (Ermakov N.A. et al. 2020, 2018; Greyasov
V.I. et al. 2018) Complications of hernioplasty lead to an increase in postoperative beda day
and an outpatient period of follow-up treatment, a sharp increase in material costs for
treatment. Treatment of late complications of allogernioplasty (postoperative fistulas, mesh
implant rejections) requires repeated additional hospitalizations and outpatient treatment
courses (Botezatu A.A. et al., 2018, 2016; Gogia B.Sh., Alyautdinov R.R. 2018, Olsson A, et
al 2021).
In modern times, one of the priority areas of scientific research in herniology is the
improvement of prosthetic plastics and the development of methods for the prevention of
seromas, which are the most common complication of the course of the postoperative period and
occur in a wide range from 0.8% to 60% (Belokonev V.I. Grachev B.D. 2018, Galimov O.V. et al.
2018, 2016, Paasch C, et al. 2021, 2019) Retromuscular plasty of the anterior abdominal wall
is currently the most physiological and reliable method of surgery for hernias of median
localization. Optimal methods of plastic surgery for median and lateral hernias are
indicated, including in clinical recommendations, but the question of plastic surgery for
ventral postoperative hernias of median-lateral localization remains open. (Clinical
recommendations "Postoperative ventral hernia", 2017) Variant anatomy of vessels and nerves
of the anterior abdominal wall for herniologists is important in the development of surgical
techniques that minimize traumatization of neurovascular bundles during anterior abdominal
wall plastic surgery. In this way, it is possible to reduce blood and lymph flow from
cellular spaces, preserve the neurovascular trophic anatomical formations of the anterior
abdominal wall and reduce the risk of postoperative complications. Based on the above, the
development of surgical techniques that minimize traumatization of neurovascular bundles is
an urgent task. The development of plastic methods for combined mid-lateral hernias is also
an urgent task of modern surgery.
The aim of the study:
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.
Research objectives:
1. To study the topographic and variant anatomy of the vessels and nerves of the
retromuscular, preperitoneal, post-peritoneal and pre-bubble cellular spaces of the
anterior abdominal wall. To determine the most probable sources of blood and lymph flow
from the anatomical formations forming the bed of the endoprosthesis.
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. To develop a technique for plasty of the anterior abdominal wall in mid-lateral
postoperative hernias with the combination of retromuscular and subaponeurotic spaces.
4. To test the developed methods in the clinic, to evaluate their effectiveness at the
stages of immediate results from the standpoint of evidence-based medicine.
5. To investigate the long-term results of using the developed methods.
Materials and methods of research It is planned to analyze the results of CT scans of 20
patients with Incisional ventral hernia to study the features of blood supply to the anterior
abdominal wall using the Autoplan hardware software package.
The experimental part
It is planned to study the variant anatomy of the anterior abdominal wall on 20 unfixed
corpses. To study:
- the presence of vessels perforating the white line of the abdomen;
- vessels behind the xiphoid process and the lower third of the sternum;
- vessels of the pre-bubble space;
- how far the intercostal neurovascular bundles (SNPs) go into the retromuscular space,
how to minimize their intersection when preparing the implant bed.
- Separately investigate the retromuscular and subaponeurotic spaces and ways of combining
them.
Clinical part
1. 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 Incisional ventral hernia 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.
4. The comparison groups will include patients who underwent retromuscular plastic surgery
followed by aspiration drainage of the prosthesis bed. The analysis of the results will
necessarily take into account the presence of obesity and coagulopathy. In addition to
general clinical studies, CT before surgery and dynamic ultrasound examination of the
anterior abdominal wall after surgery will be performed. Particular attention will be
paid to the presence and volume of fluid 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. According to the Clavien-Dindo scale, complications belong to
class 3B.
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.
The data obtained will be evaluated using the IBM SPSS Advanced Statistica application
package. The results of the study will be generated using Word, Excel, and Microsoft Office
software. In the course of the work, modern statistical research methods will be used:
descriptive statistics, methods for assessing the significance of differences using
parametric and nonparametric criteria, methods of correlation and variance analysis, cluster
analysis, forecasting using logistic regressions.
Planned scientific novelty and practical value
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 plasty. 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.
A brief description of the planned innovations
1. Development of a new method of plasty of the anterior abdominal wall of mid-lateral
postoperative ventral hernias
2. Development of techniques to minimize traumatization of the neurovascular bundles of the
anterior abdominal wall and reduce postoperative complications.
