Clinical trial NCT04222517: The Use of Local Hemostatic in Patients With Large Incisional Hernias
Official title: The Use of Local Hemostatic in Patients With Large Incisional Hernias: Randomized Controlled Trial Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hernia, Ventral
Keywords: hernia
Lead sponsor: Nijznevartovsk County Clinical Hospital
Sponsor class: OTHER
First posted: 2020-01-10
Enrollment: 66
Sex: ALL
Minimum age (years): 25
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: PREVENTION

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).

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

Primary outcomes:
measure: drainage duration
timeFrame: from 1 to 6 days after operation
measure: the amount of the exudate from post-op wound
timeFrame: from 1 to 6 days after operation
measure: the ultrasound changes of fluid collections in the postoperative wound
timeFrame: on the 3rd, 7th, 10th, 12th, 15th, 18th, 21st, 25th, 28th, 30th days after drainage removal.
measure: the number of necessary punctures of the postoperative wound
timeFrame: up to 30 days after drains removal
measure: amount of seromas
timeFrame: up to 30 days after drains removal
measure: other postoperative wound complications
timeFrame: up to 30 days after drains removal
measure: white blood cell count in exudate from post-op wound
timeFrame: from 1 to 6 days after operation
measure: the number of lymphocytes in exudate from post-op wound
timeFrame: from 1 to 6 days after operation
measure: the amount of C-RP in exudate from post-op wound
timeFrame: from 1 to 6 days after operation
measure: the amount of Albuminum in exudate from post-op wound
timeFrame: from 1 to 6 days after operation
Secondary outcomes:
measure: Lenght of the Hospital stay
timeFrame: from 4 to 18 days
measure: post-operative pain scores using numerical rating on Visual Analogue Scale (VAS)
timeFrame: Ten days after surgery twice a day (at 06:00 AM and at 06:00 PM).
measure: The concentration of NSAD in mg of applied analgesics
timeFrame: up to 7-10 days after surgery
measure: The concentration of Tramadol in mg of applied analgesics
timeFrame: up to 7-10 days after surgery
measure: The concentration of Trimeperidine in mg of applied analgesics
timeFrame: up to 7-10 days after surgery
measure: Duration of use NSAD in days
timeFrame: up to 7-10 days after surgery
measure: Duration of use Tramadol in days
timeFrame: up to 7-10 days after surgery
measure: Duration of use Trimeperidine in days
timeFrame: up to 7-10 days after surgery
Other outcomes:
Locations:
city: Nijnevartovsk
country: Russian Federation
facility: Nijnevartovsk Clinical County Hospital
Study officials:
affiliation: Omsk state Medical Univesity
name: Pavel Kolyadko
role: PRINCIPAL_INVESTIGATOR
References: