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The 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
Nijznevartovsk County Clinical Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hernia, Ventral focused on measuring hernia

Eligibility Criteria

25 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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

First Posted
January 4, 2020
Last Updated
January 7, 2020
Sponsor
Nijznevartovsk County Clinical Hospital
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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

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The Use of Local Hemostatic in Patients With Large Incisional Hernias

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