The Use of Local Hemostatic in Patients With Large Incisional Hernias

Hernia, Ventral Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04222517
• Other study ID #: 1
• Status: Completed
• Phase: N/A
• Start date: September 10, 2017
• Est. completion date: January 4, 2020

Study information

• Verified date: January 2020
• Source: Nijznevartovsk County Clinical Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: January 4, 2020
• Est. primary completion date: October 15, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Hernia
• Hernia, Ventral
• Incisional Hernia

Intervention

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

Locations

Country	Name	City	State
Russian Federation	Nijnevartovsk Clinical County Hospital	Nijnevartovsk

Sponsors (1)

Lead Sponsor	Collaborator
Nijznevartovsk County Clinical Hospital

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	drainage duration	Duration of drainage in days	from 1 to 6 days after operation
Primary	the amount of the exudate from post-op wound	How many ml is exudate from the wound	from 1 to 6 days after operation
Primary	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.
Primary	the number of necessary punctures of the postoperative wound	How many punctures need to treatment fluid collections	up to 30 days after drains removal
Primary	amount of seromas	use Morales-Conde classification	up to 30 days after drains removal
Primary	other postoperative wound complications	such as SSI, thromboembolism, therapeutic complications	up to 30 days after drains removal
Primary	white blood cell count in exudate from post-op wound	The number of leukocytes	from 1 to 6 days after operation
Primary	the number of lymphocytes in exudate from post-op wound	The number of lymphocytes	from 1 to 6 days after operation
Primary	the amount of C-RP in exudate from post-op wound	The number of C-RP	from 1 to 6 days after operation
Primary	the amount of Albuminum in exudate from post-op wound	The number of Albuminum	from 1 to 6 days after operation
Secondary	Lenght of the Hospital stay	Days	from 4 to 18 days
Secondary	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). A ten-point scale, where 0 points - no pain and 10 points - unbearable pain	Ten days after surgery twice a day (at 06:00 AM and at 06:00 PM).
Secondary	The concentration of NSAD in mg of applied analgesics	NSAD (Ketoprofen)	up to 7-10 days after surgery
Secondary	The concentration of Tramadol in mg of applied analgesics	Tramadol	up to 7-10 days after surgery
Secondary	The concentration of Trimeperidine in mg of applied analgesics	Trimeperidine	up to 7-10 days after surgery
Secondary	Duration of use NSAD in days	NSAD (Ketoprofen)	up to 7-10 days after surgery
Secondary	Duration of use Tramadol in days	Tramadol	up to 7-10 days after surgery
Secondary	Duration of use Trimeperidine in days	Trimeperidine	up to 7-10 days after surgery