The Use of Local Hemostatic in Patients With Large Incisional Hernias

Not Applicable

Completed

• Conditions: Hernia, Ventral
• Interventions: 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

• Registration Number: NCT04222517
• Lead Sponsor: Nijznevartovsk County Clinical Hospital

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).

Study Timeline

• Study Start: 2017-09-10
• Primary Completion: 2018-10-15
• Status Verified: 2020-01
• Study Completion: 2020-01-04
• Study First Submitted: 2020-01-04
• Study First Submitted QC: 2020-01-07
• Last Update Submitted: 2020-01-07
• Study First Posted: 2020-01-10
• Last Update Posted: 2020-01-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Standart sublay retromuscular technique	Incisional hernia repair by the mesh implant in sublay retromusuclar position	Apply standard intervention (sublay retromuscular)
Standart sublay retromuscular technique with Hemoblock	Incisional hernia repair by the mesh implant in sublay retromusuclar position with using a local hemostatic Hemoblock	Local hemostatic Hemoblock is used in retro-muscular and subcutaneous spaces

Primary Outcome Measures

Name	Time	Method
amount of seromas	up to 30 days after drains removal	use Morales-Conde classification
drainage duration	from 1 to 6 days after operation	Duration of drainage in days
the amount of C-RP in exudate from post-op wound	from 1 to 6 days after operation	The number of C-RP
the ultrasound changes of fluid collections in the postoperative wound	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
the number of lymphocytes in exudate from post-op wound	from 1 to 6 days after operation	The number of lymphocytes
the amount of the exudate from post-op wound	from 1 to 6 days after operation	How many ml is exudate from the wound
the number of necessary punctures of the postoperative wound	up to 30 days after drains removal	How many punctures need to treatment fluid collections
other postoperative wound complications	up to 30 days after drains removal	such as SSI, thromboembolism, therapeutic complications
white blood cell count in exudate from post-op wound	from 1 to 6 days after operation	The number of leukocytes
the amount of Albuminum in exudate from post-op wound	from 1 to 6 days after operation	The number of Albuminum

Secondary Outcome Measures

Name	Time	Method
The concentration of NSAD in mg of applied analgesics	up to 7-10 days after surgery	NSAD (Ketoprofen)
Lenght of the Hospital stay	from 4 to 18 days	Days
The concentration of Tramadol in mg of applied analgesics	up to 7-10 days after surgery	Tramadol
The concentration of Trimeperidine in mg of applied analgesics	up to 7-10 days after surgery	Trimeperidine
Duration of use NSAD in days	up to 7-10 days after surgery	NSAD (Ketoprofen)
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).	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
Duration of use Trimeperidine in days	up to 7-10 days after surgery	Trimeperidine
Duration of use Tramadol in days	up to 7-10 days after surgery	Tramadol

Trial Locations

Locations (1)

Nijnevartovsk Clinical County Hospital; 🇷🇺 Nijnevartovsk, Russian Federation