An Efficiency/Safety Study of Surgical Tissue Glue to Tre... | NCT01669837

Studies
An Efficiency/Safety Study of Surgical Tissue Glue to Treat Inguinal Hernias

NCT01669837

Sponsor

Duomed

Status

Completed

Last Update Posted

Jun 18, 2020Actual

Enrollment

1,000Actual

Phase

Not provided

Conditions

Inguinal Hernia

Interventions

Mesh fixation with surgical tissue glue

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2012Actual

Primary Completion Date

Mar 2020Actual

Completion Date

Mar 2020Actual

First Submitted Date

Aug 17, 2012

First Submission Date that Met QC Criteria

Aug 20, 2012

First Posted Date

Aug 21, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 18, 2020

Last Update Posted Date

Jun 18, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Prospective, multicenter, observational registry to collect data of laparoscopic inguinal hernia repair using surgical tissue glue fixation. The objective is to determine the prevalence of chronic pain at 1 year.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,000Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patient group		Administration of surgical tissue glue.	Device: Mesh fixation with surgical tissue glue

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Mesh fixation with surgical tissue glue	Device	Laparoscopic inguinal hernia repair using surgical tissue glue for mesh fixation	Patient group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Postoperative pain	Prevalence of postoperative pain evaluated by patient self-assessment using a visual analog scale.	up to 1 year

Secondary Outcomes

Measure	Description	Time Frame
Intraoperative complications	Complications such as bowel injury, major bleeding, complications due to anesthesia, nerve damage, lesion of vas deferens.	1 day
Postoperative complications	Local numbness, hematoma, seroma, wound infection, mesh infection, hernia recurrence.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patient is older than 18 years.
Written informed consent is obtained from patient.
Patient is able to complete the EQ-5D questionnaire.
Patient has a primary unilateral or primary bilateral inguinal hernia- Mesh fixation is established with solely surgical tissue glue (Ifbond™).

Exclusion Criteria:

Patient has a recurrent inguinal hernia.
Patient is treated using the Lichtenstein technique.
Mesh fixation with sutures, tacks, absorbable tacks or clips.
Patient is allergic to components of surgical tissue glue (Ifbond™).
Patient has a life expectancy of less than 1 year.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with a primary inguinal hernia

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kurt Van der Speeten, MD	Ziekenhuis Oost-Limburg	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ziekenhuis Oost-Limburg		Genk	Limburg	3600	Belgium

Condition Browse Module

MeSH Terms

ID	Term
D006552	Hernia, Inguinal

Ancestor Terms

ID	Term
D046449	Hernia, Abdominal
D006547	Hernia
D020763	Pathological Conditions, Anatomical
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided