Sutured vs Sutureless Mesh Fixation for Onlay Ventral Her... | NCT06209450

Studies
Sutured vs Sutureless Mesh Fixation for Onlay Ventral Hernia Repair

NCT06209450

Sponsor

Assiut University

Status

Unknown status

Last Update Posted

Jan 17, 2024Actual

Enrollment

1Estimated

Phase

Not Applicable

Conditions

Ventral Hernia

Interventions

Ventral hernia repair with mesh fixation

Countries

Not provided

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

Jan 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2024Estimated

Primary Completion Date

Mar 1, 2025Estimated

Completion Date

Mar 1, 2025Estimated

First Submitted Date

Jan 5, 2024

First Submission Date that Met QC Criteria

Jan 5, 2024

First Posted Date

Jan 17, 2024Actual

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

Jan 5, 2024

Last Update Posted Date

Jan 17, 2024Actual

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

Comparison beta sutured and suturless mesh fixation for ventral hernia regarding recurrence rates and complications rate

Detailed Description

Ventral hernia repair is common procedure with over 250000 repairs each year in the unites states . Most ventral hernias are repaired using tension free type of repair using mesh that bridge the defect and reinforce the abdominal wall .

The mesh fixation technique has impact on recurrence rates,chronic pain and complications rates . Suturless ventral hernia repair with sealing agent fixation proved to be durable with comperable complication profile to other techniques.

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

1Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Ventral hernia repair	Experimental		Procedure: Ventral hernia repair with mesh fixation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ventral hernia repair with mesh fixation	Procedure	Sutured versus suturless mesh fixation	Ventral hernia repair

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Complications	Intraoperative and post operative complications occur due to technique used in study	One year after surgery

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

ventral hernia
both sexes

Exclusion Criteria:

obstructed or complicated ventral hernia
incisional hernia
recurrent hernia
multiple ventral hernia
large hernia more than 5 cm

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Khaled Muhammad Mahmoud	Contact	01069094017		Khaledgad19844@gmail.com
Moray Muhammad Morsy, Prof	Contact	01093688097		m.morsy@aun.edu.eg

Overall Officials

Not provided

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006555	Hernia, Ventral

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