Hernia, VentralNCT04222517
The Use of Local Hemostatic in Patients With Large Incisional Hernias
A study testing Incisional hernia repair by the mesh implant in sublay retromusuclar position and Incisional hernia repair by the mesh implant in sublay retromusuclar position with using a local hemostatic Hemoblock in people with Hernia, Ventral, run by Nijznevartovsk County Clinical Hospital at 1 site in Russia.
Trial summary
Design of a simple blind randomized controlled trial study. Large incisional hernia repair with use of local hemostatic Hemoblock Read more about this study
- Who is it for?
- Ages 25 to 75 years
- Conditions the study is for
- Hernia, Ventral
- What is being tested?
- Incisional hernia repair by the mesh implant in sublay retromusuclar position and Incisional hernia repair by the mesh implant in sublay retromusuclar position with using a local hemostatic Hemoblock
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteRussia
- Study dates
- 10 Sep 2017to 4 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- age older than 75 years
- decompensated concomitant pathology, ASA≥IV
- patient refusal to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Use of Local Hemostatic in Patients With Large Incisional Hernias: Randomized Controlled Trial Study
Design of a simple blind randomized controlled trial study. Large incisional hernia repair with use of local hemostatic Hemoblock
Read the 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).
- Conditions
- Hernia, Ventral
- Being tested
- 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
- Keywords
- hernia
- Medical subject headings
- Hernia, Ventral, Hernia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Incisional hernia repair by the mesh implant in sublay retromusuclar positionProcedure or surgery
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 or surgery
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).
| Study group | Role | What they receive |
|---|---|---|
| Standart sublay retromuscular technique | Experimental | Apply standard intervention (sublay retromuscular) Receives: Procedure: Incisional hernia repair by the mesh implant in sublay retromusuclar position |
| Standart sublay retromuscular technique with Hemoblock | Experimental | Local hemostatic Hemoblock is used in retro-muscular and subcutaneous spaces Receives: Procedure: Incisional hernia repair by the mesh implant in sublay retromusuclar position with using a local hemostatic Hemoblock |
What is being measured
The primary outcome is the main question the study is designed to answer.
drainage duration
Duration of drainage in days
Measured: from 1 to 6 days after operation
the amount of the exudate from post-op wound
How many ml is exudate from the wound
Measured: 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
Measured: 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
Measured: up to 30 days after drains removal
amount of seromas
use Morales-Conde classification
Measured: up to 30 days after drains removal
other postoperative wound complications
such as SSI, thromboembolism, therapeutic complications
Measured: up to 30 days after drains removal
white blood cell count in exudate from post-op wound
The number of leukocytes
Measured: from 1 to 6 days after operation
the number of lymphocytes in exudate from post-op wound
The number of lymphocytes
Measured: from 1 to 6 days after operation
the amount of C-RP in exudate from post-op wound
The number of C-RP
Measured: from 1 to 6 days after operation
the amount of Albuminum in exudate from post-op wound
The number of Albuminum
Measured: from 1 to 6 days after operation
Secondary outcomes (8)
Lenght of the Hospital stay
Days
Measured: 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
Measured: 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)
Measured: up to 7-10 days after surgery
The concentration of Tramadol in mg of applied analgesics
Tramadol
Measured: up to 7-10 days after surgery
The concentration of Trimeperidine in mg of applied analgesics
Trimeperidine
Measured: up to 7-10 days after surgery
Duration of use NSAD in days
NSAD (Ketoprofen)
Measured: up to 7-10 days after surgery
Duration of use Tramadol in days
Tramadol
Measured: up to 7-10 days after surgery
Duration of use Trimeperidine in days
Trimeperidine
Measured: up to 7-10 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2020
- Study start10 Sep 2017
- Primary completion15 Oct 2018
- Study completion4 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hernia, VentralStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nijznevartovsk County Clinical Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pavel Kolyadko, Principal investigator, Omsk state Medical Univesity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04222517
- Sponsor's protocol ID
- 1
- Status last verified
- Jan 2020
- First submitted
- 4 Jan 2020
- Last updated
- 10 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Local Hemostatic in Patients With Large Incisional Hernias: Randomized Controlled Trial Study
- ClinicalTrials.gov ID
- NCT04222517
- Acronym / sponsor ID
- 1
- Conditions
- Hernia, Ventral
- Keywords
- hernia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Nijznevartovsk County Clinical HospitalUniversity, hospital or other
- Study start
- 10 Sep 2017 (actual)
- Primary completion
- 15 Oct 2018 (actual)
- Study completion
- 4 Jan 2020 (actual)
- First posted
- 10 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standart sublay retromuscular technique | Experimental | Procedure: Incisional hernia repair by the mesh implant in sublay retromusuclar positionApply standard intervention (sublay retromuscular) |
| Standart sublay retromuscular technique with Hemoblock | Experimental | Procedure: Incisional hernia repair by the mesh implant in sublay retromusuclar position with using a local hemostatic HemoblockLocal hemostatic Hemoblock is used in retro-muscular and subcutaneous spaces |
Who may qualify
- Ages
- 25 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- age older than 75 years
- decompensated concomitant pathology, ASA≥IV
- patient refusal to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Incisional hernia repair by the mesh implant in sublay retromusuclar positionIncisional 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). | Procedure or surgery | Standart sublay retromuscular technique |
| Incisional hernia repair by the mesh implant in sublay retromusuclar position with using a local hemostatic HemoblockIncisional 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). | Procedure or surgery | Standart sublay retromuscular technique with Hemoblock |
Primary outcome
drainage duration
Time frame: from 1 to 6 days after operation
Duration of drainage in days
the amount of the exudate from post-op wound
Time frame: 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
Time frame: 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
Time frame: up to 30 days after drains removal
How many punctures need to treatment fluid collections
amount of seromas
Time frame: up to 30 days after drains removal
use Morales-Conde classification
other postoperative wound complications
Time frame: up to 30 days after drains removal
such as SSI, thromboembolism, therapeutic complications
white blood cell count in exudate from post-op wound
Time frame: from 1 to 6 days after operation
The number of leukocytes
the number of lymphocytes in exudate from post-op wound
Time frame: from 1 to 6 days after operation
The number of lymphocytes
the amount of C-RP in exudate from post-op wound
Time frame: from 1 to 6 days after operation
The number of C-RP
the amount of Albuminum in exudate from post-op wound
Time frame: from 1 to 6 days after operation
The number of Albuminum
8 secondary outcomes
Lenght of the Hospital stay
Time frame: from 4 to 18 days
post-operative pain scores using numerical rating on Visual Analogue Scale (VAS)
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
Time frame: up to 7-10 days after surgery
The concentration of Tramadol in mg of applied analgesics
Time frame: up to 7-10 days after surgery
The concentration of Trimeperidine in mg of applied analgesics
Time frame: up to 7-10 days after surgery
Duration of use NSAD in days
Time frame: up to 7-10 days after surgery
Duration of use Tramadol in days
Time frame: up to 7-10 days after surgery
Duration of use Trimeperidine in days
Time frame: up to 7-10 days after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pavel Kolyadko principal investigator
Omsk state Medical Univesity
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Incisional hernia repair by the mesh implant in sublay retromusuclar position and Incisional hernia repair by the mesh implant in sublay retromusuclar position with using a local hemostatic Hemoblock in people with Hernia, Ventral, run by Nijznevartovsk County Clinical Hospital at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
drainage duration (time frame: from 1 to 6 days after operation). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2020; AzTrials last refreshed its copy on 8 Nov 2026.