Back to resultsThe Use of Local Hemostatic in Patients With Large Incisional Hernias
Primary Purpose
Hernia, Ventral
Status
Completed
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
Incisional hernia repair by the mesh implant in sublay retromusuclar position
Incisional hernia repair by the mesh implant in sublay retromusuclar position with using a local hemostatic Hemoblock
Sponsored by
About this trial
This is an interventional prevention trial for Hernia, Ventral focused on measuring hernia
Eligibility Criteria
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
Sites / Locations
- Nijnevartovsk Clinical County Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Standart sublay retromuscular technique
Standart sublay retromuscular technique with Hemoblock
Arm Description
Apply standard intervention (sublay retromuscular)
Local hemostatic Hemoblock is used in retro-muscular and subcutaneous spaces
Outcomes
Primary Outcome Measures
drainage duration
Duration of drainage in days
the amount of the exudate from post-op wound
How many ml is exudate from the wound
the ultrasound changes of fluid collections in the postoperative wound
volume of the fluid collections in the post-op wound after drains removal
the number of necessary punctures of the postoperative wound
How many punctures need to treatment fluid collections
amount of seromas
use Morales-Conde classification
other postoperative wound complications
such as SSI, thromboembolism, therapeutic complications
white blood cell count in exudate from post-op wound
The number of leukocytes
the number of lymphocytes in exudate from post-op wound
The number of lymphocytes
the amount of C-RP in exudate from post-op wound
The number of C-RP
the amount of Albuminum in exudate from post-op wound
The number of Albuminum
Secondary Outcome Measures
Lenght of the Hospital stay
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
The concentration of NSAD in mg of applied analgesics
NSAD (Ketoprofen)
The concentration of Tramadol in mg of applied analgesics
Tramadol
The concentration of Trimeperidine in mg of applied analgesics
Trimeperidine
Duration of use NSAD in days
NSAD (Ketoprofen)
Duration of use Tramadol in days
Tramadol
Duration of use Trimeperidine in days
Trimeperidine
Full Information
NCT ID
NCT04222517
First Posted
January 4, 2020
Last Updated
January 7, 2020
Sponsor
Nijznevartovsk County Clinical Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04222517
Brief Title
The Use of Local Hemostatic in Patients With Large Incisional Hernias
Official Title
The Use of Local Hemostatic in Patients With Large Incisional Hernias: Randomized Controlled Trial Study
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
September 10, 2017 (Actual)
Primary Completion Date
October 15, 2018 (Actual)
Study Completion Date
January 4, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nijznevartovsk County Clinical Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hernia, Ventral
Keywords
hernia
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
Participant
Allocation
Randomized
Enrollment
66 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standart sublay retromuscular technique
Arm Type
Experimental
Arm Description
Apply standard intervention (sublay retromuscular)
Arm Title
Standart sublay retromuscular technique with Hemoblock
Arm Type
Experimental
Arm Description
Local hemostatic Hemoblock is used in retro-muscular and subcutaneous spaces
Intervention Type
Procedure
Intervention Name(s)
Incisional hernia repair by the mesh implant in sublay retromusuclar position
Intervention Description
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).
Intervention Type
Procedure
Intervention Name(s)
Incisional hernia repair by the mesh implant in sublay retromusuclar position with using a local hemostatic Hemoblock
Intervention Description
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).
Primary Outcome Measure Information:
Title
drainage duration
Description
Duration of drainage in days
Time Frame
from 1 to 6 days after operation
Title
the amount of the exudate from post-op wound
Description
How many ml is exudate from the wound
Time Frame
from 1 to 6 days after operation
Title
the ultrasound changes of fluid collections in the postoperative wound
Description
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.
Title
the number of necessary punctures of the postoperative wound
Description
How many punctures need to treatment fluid collections
Time Frame
up to 30 days after drains removal
Title
amount of seromas
Description
use Morales-Conde classification
Time Frame
up to 30 days after drains removal
Title
other postoperative wound complications
Description
such as SSI, thromboembolism, therapeutic complications
Time Frame
up to 30 days after drains removal
Title
white blood cell count in exudate from post-op wound
Description
The number of leukocytes
Time Frame
from 1 to 6 days after operation
Title
the number of lymphocytes in exudate from post-op wound
Description
The number of lymphocytes
Time Frame
from 1 to 6 days after operation
Title
the amount of C-RP in exudate from post-op wound
Description
The number of C-RP
Time Frame
from 1 to 6 days after operation
Title
the amount of Albuminum in exudate from post-op wound
Description
The number of Albuminum
Time Frame
from 1 to 6 days after operation
Secondary Outcome Measure Information:
Title
Lenght of the Hospital stay
Description
Days
Time Frame
from 4 to 18 days
Title
post-operative pain scores using numerical rating on Visual Analogue Scale (VAS)
Description
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).
Title
The concentration of NSAD in mg of applied analgesics
Description
NSAD (Ketoprofen)
Time Frame
up to 7-10 days after surgery
Title
The concentration of Tramadol in mg of applied analgesics
Description
Tramadol
Time Frame
up to 7-10 days after surgery
Title
The concentration of Trimeperidine in mg of applied analgesics
Description
Trimeperidine
Time Frame
up to 7-10 days after surgery
Title
Duration of use NSAD in days
Description
NSAD (Ketoprofen)
Time Frame
up to 7-10 days after surgery
Title
Duration of use Tramadol in days
Description
Tramadol
Time Frame
up to 7-10 days after surgery
Title
Duration of use Trimeperidine in days
Description
Trimeperidine
Time Frame
up to 7-10 days after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pavel Kolyadko
Organizational Affiliation
Omsk state Medical Univesity
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nijnevartovsk Clinical County Hospital
City
Nijnevartovsk
ZIP/Postal Code
628606
Country
Russian Federation
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Use of Local Hemostatic in Patients With Large Incisional Hernias
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