The Use of Local Hemostatic in Patients With Large Incisional Hernias

Study Overview
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Brief Summary
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Design of a simple blind randomized controlled trial study. Large incisional hernia repair with use of local hemostatic Hemoblock

Detailed Description
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Design of a simple blind randomized controlled trial study. The total number of subjects was 66. In the main group (A) - 33, in the other group (B) - 33. Operation - sublay retromuscular using prolene mesh implant. In group A Hemoblock 15 ml in the retromuscular and 15 ml in the subcutaneous spaces were used. Wounds were drained by vacuum-suction drainage. Postoperative monitoring of early ultrasound examinations on the 3rd, 7th, 10th, 12th, 15th, 18th, 21st, 25th, 28th, 30th days after drainage removal. In group B were used a standard intervention (sublay retromuscular).

Official Title
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The Use of Local Hemostatic in Patients With Large Incisional Hernias: Randomized Controlled Trial Study

Conditions
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Hernia, Ventral

Intervention / Treatment
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* Procedure: Incisional hernia repair by the mesh implant in sublay retromusuclar position
* Procedure: Incisional hernia repair by the mesh implant in sublay retromusuclar position with using a local hemostatic Hemoblock


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ASA I, II, III the absence of oncological pathology consent to participate in the study Large incisional hernia (hernial defect ≥10 cm in diameter and/or area of hernial defect ≥100 cm2) according to the classification of EHS, 2009 (W3); age 25-75 years Exclusion Criteria: age older than 75 years decompensated concomitant pathology, ASA≥IV patient refusal to participate in the study

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Standart sublay retromuscular technique<br>Apply standard intervention (sublay retromuscular) | Procedure: Incisional hernia repair by the mesh implant in sublay retromusuclar position<br>* Incisional hernia repair using mesh prolene implant in sublay retromuscular position. Dissect the posterior rectus sheets, suture them continuously, formed a retromuscular space in which the standard prolene mesh implant is installed. Perform hemostasis. Install the drainage tube into the retromuscular space. After that, the anterior rectus sheets were sutured, hemostasis was performed, a drainage tube was installed in the subcutaneous tissue. Drainage tubes were connected to the UnoVac vacuum aspiration system (Unomedical, Denmark).<br>|
| Experimental: Standart sublay retromuscular technique with Hemoblock<br>Local hemostatic Hemoblock is used in retro-muscular and subcutaneous spaces | Procedure: Incisional hernia repair by the mesh implant in sublay retromusuclar position with using a local hemostatic Hemoblock<br>* Incisional hernia repair using mesh prolene implant in sublay retromuscular position. Dissect the posterior rectus sheets, suture them continuously, formed a retromuscular space in which the standard prolene mesh implant is installed. Perform hemostasis. Install the drainage tube into the retromuscular space. Used a local hemostatic Hemoblock 15 ml in this space. After that, the anterior rectus sheets were sutured, hemostasis was performed, a drainage tube was installed in the subcutaneous tissue. Used a local hemostatic Hemoblock 15 ml in subcutaneus space. Drainage tubes were connected to the UnoVac vacuum aspiration system (Unomedical, Denmark).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| drainage duration | Duration of drainage in days | from 1 to 6 days after operation | 
| the amount of the exudate from post-op wound | How many ml is exudate from the wound | from 1 to 6 days after operation | 
| the ultrasound changes of fluid collections in the postoperative wound | volume of the fluid collections in the post-op wound after drains removal | on the 3rd, 7th, 10th, 12th, 15th, 18th, 21st, 25th, 28th, 30th days after drainage removal. | 
| the number of necessary punctures of the postoperative wound | How many punctures need to treatment fluid collections | up to 30 days after drains removal | 
| amount of seromas | use Morales-Conde classification | up to 30 days after drains removal | 
| other postoperative wound complications | such as SSI, thromboembolism, therapeutic complications | up to 30 days after drains removal | 
| white blood cell count in exudate from post-op wound | The number of leukocytes | from 1 to 6 days after operation | 
| the number of lymphocytes in exudate from post-op wound | The number of lymphocytes | from 1 to 6 days after operation | 
| the amount of C-RP in exudate from post-op wound | The number of C-RP | from 1 to 6 days after operation | 
| the amount of Albuminum in exudate from post-op wound | The number of Albuminum | from 1 to 6 days after operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lenght of the Hospital stay | Days | from 4 to 18 days | 
| post-operative pain scores using numerical rating on Visual Analogue Scale (VAS) | Ten days after surgery twice a day (at 06:00 AM and at 06:00 PM). A ten-point scale, where 0 points - no pain and 10 points - unbearable pain | Ten days after surgery twice a day (at 06:00 AM and at 06:00 PM). | 
| The concentration of NSAD in mg of applied analgesics | NSAD (Ketoprofen) | up to 7-10 days after surgery | 
| The concentration of Tramadol in mg of applied analgesics | Tramadol | up to 7-10 days after surgery | 
| The concentration of Trimeperidine in mg of applied analgesics | Trimeperidine | up to 7-10 days after surgery | 
| Duration of use NSAD in days | NSAD (Ketoprofen) | up to 7-10 days after surgery | 
| Duration of use Tramadol in days | Tramadol | up to 7-10 days after surgery | 
| Duration of use Trimeperidine in days | Trimeperidine | up to 7-10 days after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hernia