Hernia, Ventral
Conditions
Keywords
hernia
Brief summary
Design of a simple blind randomized controlled trial study. Large incisional hernia repair with use of local hemostatic Hemoblock
Detailed description
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).
Interventions
PROCEDUREIncisional hernia repair by the mesh implant in sublay retromusuclar position
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).
PROCEDUREIncisional hernia repair by the mesh implant in sublay retromusuclar position with using a local hemostatic Hemoblock
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).
Sponsors
Nijznevartovsk County Clinical Hospital
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
25 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. ASA I, II, III 2. the absence of oncological pathology 3. consent to participate in the study 4. 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
1. age older than 75 years 2. decompensated concomitant pathology, ASA≥IV 3. patient refusal to participate in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the amount of Albuminum in exudate from post-op wound | from 1 to 6 days after operation | The number of Albuminum |
| the amount of the exudate from post-op wound | from 1 to 6 days after operation | How many ml is exudate from the wound |
| the ultrasound changes of fluid collections in the postoperative wound | on the 3rd, 7th, 10th, 12th, 15th, 18th, 21st, 25th, 28th, 30th days after drainage removal. | volume of the fluid collections in the post-op wound after drains removal |
| the number of necessary punctures of the postoperative wound | up to 30 days after drains removal | How many punctures need to treatment fluid collections |
| amount of seromas | up to 30 days after drains removal | use Morales-Conde classification |
| other postoperative wound complications | up to 30 days after drains removal | such as SSI, thromboembolism, therapeutic complications |
| white blood cell count in exudate from post-op wound | from 1 to 6 days after operation | The number of leukocytes |
| the number of lymphocytes in exudate from post-op wound | from 1 to 6 days after operation | The number of lymphocytes |
| the amount of C-RP in exudate from post-op wound | from 1 to 6 days after operation | The number of C-RP |
| drainage duration | from 1 to 6 days after operation | Duration of drainage in days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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). | 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 |
| The concentration of NSAD in mg of applied analgesics | up to 7-10 days after surgery | NSAD (Ketoprofen) |
| The concentration of Tramadol in mg of applied analgesics | up to 7-10 days after surgery | Tramadol |
| The concentration of Trimeperidine in mg of applied analgesics | up to 7-10 days after surgery | Trimeperidine |
| Duration of use NSAD in days | up to 7-10 days after surgery | NSAD (Ketoprofen) |
| Duration of use Tramadol in days | up to 7-10 days after surgery | Tramadol |
| Duration of use Trimeperidine in days | up to 7-10 days after surgery | Trimeperidine |
| Lenght of the Hospital stay | from 4 to 18 days | Days |
Countries
Russia
Outcome results
None listed