The Use of Local Hemostatic in Patients With Large Incisional Hernias

NCT ID: NCT04222517

Last Updated: 2020-01-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-10
• Study Completion Date: 2020-01-04

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).

Conditions

Hernia, Ventral

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Standart sublay retromuscular technique

Apply standard intervention (sublay retromuscular)

Group Type: EXPERIMENTAL

Incisional hernia repair by the mesh implant in sublay retromusuclar position

Intervention Type: PROCEDURE

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).

Standart sublay retromuscular technique with Hemoblock

Local hemostatic Hemoblock is used in retro-muscular and subcutaneous spaces

Group Type: EXPERIMENTAL

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

Intervention Type: PROCEDURE

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).

Interventions

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).

Intervention Type: 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).

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nijznevartovsk County Clinical Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pavel Kolyadko

Role: PRINCIPAL_INVESTIGATOR

Omsk state Medical Univesity

Locations

Nijnevartovsk Clinical County Hospital

Nizhnevartovsk, , Russia

Countries

Russia

Other Identifiers

1

Identifier Type: -

Identifier Source: org_study_id