The Use of Local Hemostatic in Patients With Large Incisional Hernias

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

Study Overview

• Status: Completed
• Conditions: Hernia, Ventral
• Intervention / Treatment: Procedure: Incisional hernia repair by the mesh implant in sublay retromusuclar position; Procedure: Incisional hernia repair by the mesh implant in sublay retromusuclar position with using a 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 Type: Interventional
• Enrollment (Actual): 66
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Russian Federation
  • Nijnevartovsk, Russian Federation, 628606
    • Nijnevartovsk Clinical County Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Standart sublay retromuscular technique; Apply standard intervention (sublay retromuscular)	Procedure: Incisional 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).
Experimental: Standart sublay retromuscular technique with Hemoblock; Local hemostatic Hemoblock is used in retro-muscular and subcutaneous spaces	Procedure: Incisional 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
drainage duration	Duration of drainage in days	from 1 to 6 days after operation
the amount of the exudate from post-op wound	How many ml is exudate from the wound	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	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	up to 30 days after drains removal
amount of seromas	use Morales-Conde classification	up to 30 days after drains removal
other postoperative wound complications	such as SSI, thromboembolism, therapeutic complications	up to 30 days after drains removal
white blood cell count in exudate from post-op wound	The number of leukocytes	from 1 to 6 days after operation
the number of lymphocytes in exudate from post-op wound	The number of lymphocytes	from 1 to 6 days after operation
the amount of C-RP in exudate from post-op wound	The number of C-RP	from 1 to 6 days after operation
the amount of Albuminum in exudate from post-op wound	The number of Albuminum	from 1 to 6 days after operation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lenght of the Hospital stay	Days	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	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)	up to 7-10 days after surgery
The concentration of Tramadol in mg of applied analgesics	Tramadol	up to 7-10 days after surgery
The concentration of Trimeperidine in mg of applied analgesics	Trimeperidine	up to 7-10 days after surgery
Duration of use NSAD in days	NSAD (Ketoprofen)	up to 7-10 days after surgery
Duration of use Tramadol in days	Tramadol	up to 7-10 days after surgery
Duration of use Trimeperidine in days	Trimeperidine	up to 7-10 days after surgery

Collaborators and Investigators

• Sponsor: Nijznevartovsk County Clinical Hospital
• Investigators: Principal Investigator: Pavel Kolyadko, Omsk state Medical Univesity

Study record dates

Study Major Dates

• Study Start (Actual): September 10, 2017
• Primary Completion (Actual): October 15, 2018
• Study Completion (Actual): January 4, 2020

Study Registration Dates

• First Submitted: January 4, 2020
• First Submitted That Met QC Criteria: January 7, 2020
• First Posted (Actual): January 10, 2020

Study Record Updates

• Last Update Posted (Actual): January 10, 2020
• Last Update Submitted That Met QC Criteria: January 7, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: hernia
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pathological Conditions, Anatomical; Hernia, Abdominal; Hernia; Hernia, Ventral; Incisional Hernia; Coagulants; Hemostatics
• Other Study ID Numbers: 1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No