Impact of Mesh Fixation With Tissue Adhesive

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.

ClinicalTrials.gov Identifier: NCT05934266

Recruitment Status : Recruiting

First Posted : July 6, 2023

Last Update Posted : July 6, 2023

See Contacts and Locations

View this study on the modernized ClinicalTrials.gov

Sponsor:

Information provided by (Responsible Party):

Justyna Drewniak Jakubowska, Hospital Universitario de Móstoles

Tracking Information

First Submitted Date ^ICMJE

June 12, 2023

First Posted Date ^ICMJE

July 6, 2023

Last Update Posted Date

July 6, 2023

Actual Study Start Date ^ICMJE

March 29, 2023

Estimated Primary Completion Date

November 29, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Postoperative pain assessed by visual numeric scale [ Time Frame: 6 months ]
Values come from 0 to 10, where 0 means no pain and 10 means the worst imaginable pain.
Postoperative administration of analgesics [ Time Frame: 6 months ]
Record of dose of analgesics needed: nonsteroidal anti-inflamatory drugs, opioid requirements, other analgesics requirements

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Hernia recurrence [ Time Frame: 6 months ]
Hernia recurrence rate after mesh fixation with tissue adhesive
Hematoma [ Time Frame: 1 month ]
Groin hematoma following hernioplasty with n-hexyl cyanoacrylate

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Pre-specified Outcome Measures

Not Provided

Original Other Pre-specified Outcome Measures

Not Provided

Descriptive Information

Brief Title ^ICMJE

Impact of Mesh Fixation With Tissue Adhesive

Official Title ^ICMJE

Impact of Mesh Fixation With Tissue Adhesive on Open Inguinal Hernia Repair

Brief Summary

Randomized controlled trial on mesh fixation using cyanoacrylate glue compared to standard suture in open inguinal hernia repair.

Detailed Description

Hernioplasty with suture-fixed mesh is the standard technique for the treatment of inguinal hernia, one of the most frequent pathologies in the Surgery Service. Despite its good results in terms of recurrences, it is currently under review due to the incidence of chronic postoperative pain. Up to half of the patients report some type of pain at one year of follow-up, and 15% report moderate-severe pain.

The objective of the study is to analyze whether the use of tissue adhesive (n-hexyl cyanoacrylate 0.5 ml) for mesh fixation in patients undergoing scheduled open inguinal hernioplasty results in a better postoperative evolution, with less chronic pain and less demand for analgesia, compared with a control group of patients who undergo the same surgical intervention with standard suture repair.

Study Type ^ICMJE

Interventional

Study Phase ^ICMJE

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Groin Hernia
Hernia, Inguinal
Postoperative Pain
Neuropathic Pain

Intervention ^ICMJE

Device: Use of n-hexyl cyanoacrylate for mesh fixation

Mesh fixation with tissue adhesive (n-hexyl cyanoacrylate) in open hernia repair

Study Arms ^ICMJE

Experimental: Tissue adhesive
Group of 80 patients in which mesh fixation is done using cyanoacrylate glue

Intervention: Device: Use of n-hexyl cyanoacrylate for mesh fixation
No Intervention: Standard suture
Group of 80 patients who undergo hernioplasty with standard suture

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

160

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date ^ICMJE

November 29, 2023

Estimated Primary Completion Date

November 29, 2023 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Elective open inguinal hernioplasty in patients over 18 years old

Exclusion Criteria:

Patient refusal
Laparoscopic surgery
Reintervention surgery
Urgent surgery
Cyanoacrylate allergy
Administration of intraoperative local anesthetics
Comorbidities that may affect the requirements of analgesics, such as degenerative arthropathies, fibromyalgia, etc.

Sex/Gender ^ICMJE

Sexes Eligible for Study:

All

Ages ^ICMJE

18 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers ^ICMJE

Contacts ^ICMJE

Contact: Justyna Drewniak

+34916648600 ext 8734

justyna.drewniak@salud.madrid.org

Listed Location Countries ^ICMJE

Spain

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT05934266

Other Study ID Numbers ^ICMJE

HUMostoles

Has Data Monitoring Committee

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No
Product Manufactured in and Exported from the U.S.:	No

IPD Sharing Statement ^ICMJE

Plan to Share IPD:	Yes
Plan Description:	All IPD that underlie results in a publication
Supporting Materials:	Study Protocol
Supporting Materials:	Statistical Analysis Plan (SAP)
Supporting Materials:	Informed Consent Form (ICF)
Supporting Materials:	Clinical Study Report (CSR)
Supporting Materials:	Analytic Code