The Use of Local Hemostatic in Patients With Large Incisional Hernias

Nijznevartovsk County Clinical Hospital

Status: Completed

Conditions: Hernia, Ventral

Treatments: 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

Study type: Interventional

Funder types: Other

Identifiers

NCT04222517

1

Details and patient eligibility

About

Design of a simple blind randomized controlled trial study. Large incisional hernia repair with use of local hemostatic Hemoblock

Full 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).

Enrollment: 66 patients

Sex: All

Ages: 25 to 75 years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Single Blind

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66 participants in 2 patient groups

Standart sublay retromuscular technique

Experimental group

Description:

Apply standard intervention (sublay retromuscular)

Treatment:

Procedure: Incisional hernia repair by the mesh implant in sublay retromusuclar position

Standart sublay retromuscular technique with Hemoblock

Experimental group

Description:

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

Treatment:

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