Tissue Glue vs Metallic Tackers in Mesh Fixation During T... | NCT05466084

Studies
Tissue Glue vs Metallic Tackers in Mesh Fixation During TAPP Repair.

NCT05466084

Sponsor

University of Jordan

Status

Completed

Last Update Posted

Aug 10, 2022Actual

Enrollment

50Actual

Phase

Not Applicable

Conditions

Hernia

Interventions

tissue Glue for mesh fixation
Metallic Tackers for mesh fixation

Countries

Jordan

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

Aug 2022

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

Jan 1, 2020Actual

Primary Completion Date

Aug 30, 2021Actual

Completion Date

Jul 1, 2022Actual

First Submitted Date

Jul 16, 2022

First Submission Date that Met QC Criteria

Jul 16, 2022

First Posted Date

Jul 20, 2022Actual

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

Aug 6, 2022

Last Update Posted Date

Aug 10, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Hanan Ibrahim Mansour, General surgery specialist, University of JordanPrincipal Investigator

Lead Sponsor

University of JordanOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

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

This is a randomized control trial intending to study the clinical difference between different mesh fixation techniques in laparoscopic TAPP hernioplasty of inguinal hernia for adults with unilateral and bilateral inguinal hernia , two techniques are tissue glue and surgical tackers , the target population will be divided according to an electronic generated randomization into two groups , they will be compared according to multiple variables which includes but not limited to : procedure time, early post op complication , post-operative pain , late complications , short term and long term recurrence rates .

Detailed Description

Laparoscopic transabdominal preperitoneal ( TAPP ) hernioplasty has emerged as an essential procedure for adults complaining of both unilateral and bilateral inguinal hernia , various descriptions of the procedure have been published recently, complications and recurrence rates are being calculated for each method, different mesh fixation techniques are being used by different surgeons, some use surgical tackers, some use fibrin glue and some demonstrated an equal outcome if the mesh was not fixed at all.

This is a randomized control trial intending to study the clinical difference between those different mesh fixation techniques in laparoscopic TAPP hernioplasty of inguinal hernia for adults with unilateral and bilateral inguinal hernia , two techniques are tissue glue and surgical tackers , the target population will be divided according to an electronic generated randomization into two groups , they will be compared according to multiple variables which includes but not limited to : procedure time, early post op complication , post-operative pain , late complications , short term and long term recurrence rates .

Design Module

Study Type

Interventional

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 Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
tissue glue	Experimental	mesh fixed using tissue glue	Procedure: tissue Glue for mesh fixation
metallic tackers	Experimental	mesh fixed using metallic tackers	Procedure: Metallic Tackers for mesh fixation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
tissue Glue for mesh fixation	Procedure	one arm of the study had their mesh fixed with tissue glue applied at multiple sites	tissue glue

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
postoperative pain	postoperative pain was measured using The visual analog scale ( VAS ) scored from 1-10	6 weeks

Secondary Outcomes

Measure	Description	Time Frame
postoperative complications	postoperative complications including : seroma, ssi , hematoma and others	6 weeks
operative time	operative time

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

all Adult Patients ages between 18 and 80 years old, males and females, inguinal hernias, unilateral or bilateral and femoral hernias.

Exclusion Criteria:

operations which were converted from TAPP to other procedures (such as open repair or TEP).
Patients who were unfit for general anesthesia
patients who refused to participate in the study
patients with chronic pain disorders requiring long term pain management before the procedure.
cases with complicated hernias that required emergency repair.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Jordan , faculty of medicine		Amman		11731	Jordan

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006547	Hernia

Ancestor Terms

ID	Term
D020763	Pathological Conditions, Anatomical
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided