The Use of Local Hemostatic in Patients With Large Incisional Hernias

Nijznevartovsk County Clinical Hospital66 enrolled

Overview

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

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

Conditions

Hernia, Ventral

Interventions

Incisional hernia repair by the mesh implant in sublay retromusuclar positionPROCEDURE

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).

Incisional hernia repair by the mesh implant in sublay retromusuclar position with using a local hemostatic HemoblockPROCEDURE

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).

Eligibility

Sex: ALLMin age: 25 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Nijnevartovsk Clinical County Hospital

Nizhnevartovsk, Russia

Outcomes

Primary Outcomes

drainage duration

Duration of drainage in days

Time frame: from 1 to 6 days after operation

the amount of the exudate from post-op wound

How many ml is exudate from the wound

Time frame: 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

Time frame: 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

Time frame: up to 30 days after drains removal

amount of seromas

use Morales-Conde classification

Time frame: up to 30 days after drains removal

Secondary Outcomes

Lenght of the Hospital stay

Days

Time frame: 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

Time frame: 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)