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Completed

NCT Number: NCT04222517

The Use of Local Hemostatic in Patients With Large Incisional Hernias

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

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Key information

Conditions

HERNIA, VENTRAL Hernia Hernia, Abdominal Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

25 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nijnevartovsk Clinical County Hospital

Nizhnevartovsk, 628606, Russia

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

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).

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).

Primary outcomes

  1. drainage duration

    Time frame: from 1 to 6 days after operation

    Duration of drainage in days

  2. 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

  3. 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

  4. 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

  5. amount of seromas

    Time frame: up to 30 days after drains removal

    use Morales-Conde classification

  6. other postoperative wound complications

    Time frame: up to 30 days after drains removal

    such as SSI, thromboembolism, therapeutic complications

  7. white blood cell count in exudate from post-op wound

    Time frame: from 1 to 6 days after operation

    The number of leukocytes

  8. the number of lymphocytes in exudate from post-op wound

    Time frame: from 1 to 6 days after operation

    The number of lymphocytes

  9. 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

  10. the amount of Albuminum in exudate from post-op wound

    Time frame: from 1 to 6 days after operation

    The number of Albuminum

Secondary outcomes

  1. Lenght of the Hospital stay

    Time frame: from 4 to 18 days

    Days

  2. 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).

    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

  3. The concentration of NSAD in mg of applied analgesics

    Time frame: up to 7-10 days after surgery

    NSAD (Ketoprofen)

  4. The concentration of Tramadol in mg of applied analgesics

    Time frame: up to 7-10 days after surgery

    Tramadol

  5. The concentration of Trimeperidine in mg of applied analgesics

    Time frame: up to 7-10 days after surgery

    Trimeperidine

  6. Duration of use NSAD in days

    Time frame: up to 7-10 days after surgery

    NSAD (Ketoprofen)

  7. Duration of use Tramadol in days

    Time frame: up to 7-10 days after surgery

    Tramadol

  8. Duration of use Trimeperidine in days

    Time frame: up to 7-10 days after surgery

    Trimeperidine

Sponsors and collaborators

Lead sponsor

Nijznevartovsk County Clinical Hospital

Other

Registry information

Official study title

The Use of Local Hemostatic in Patients With Large Incisional Hernias: Randomized Controlled Trial Study

Important dates

Study start
2017
Primary completion
2018
Study completion
2020
First posted
Jan 10, 2020
Registry last updated
Jan 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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