The Use of Local Hemostatic in Patients With Large Incisional Hernias

NCT04222517 | Completed

• 1 other identifier: 1
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hernia, Ventral

Keywords

hernia

Outcome Measures

Primary Outcomes (10)

• 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 Outcomes (8)

• Lenght of the Hospital stay

  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).

• The concentration of NSAD in mg of applied analgesics

  up to 7-10 days after surgery

• The concentration of Tramadol in mg of applied analgesics

  up to 7-10 days after surgery

• The concentration of Trimeperidine in mg of applied analgesics

  up to 7-10 days after surgery

Study Arms (2)

Standart sublay retromuscular technique

EXPERIMENTAL

Apply standard intervention (sublay retromuscular)

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

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

Interventions

Incisional hernia repair by the mesh implant in sublay retromusuclar position 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

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

Standart sublay retromuscular technique with Hemoblock

Eligibility Criteria

• Age: 25 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• age older than 75 years
• decompensated concomitant pathology, ASA≥IV
• patient refusal to participate in the study

Sponsors & Collaborators

• Nijznevartovsk County Clinical Hospital: lead

Study Sites (1)

Nijnevartovsk Clinical County Hospital

Nizhnevartovsk, 628606, Russia

Location

MeSH Terms

Conditions

Hernia, Ventral; Hernia

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Pavel Kolyadko

  Omsk state Medical Univesity

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2020
• First Posted: January 10, 2020
• Study Start: September 10, 2017
• Primary Completion: October 15, 2018
• Study Completion: January 4, 2020
• Last Updated: January 10, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)