Mesh Alone VS Combined Mesh and Darn in the Management of... | NCT04891601

Studies
Mesh Alone VS Combined Mesh and Darn in the Management of Primary Inguinal Hernia in Adult Males

NCT04891601

Sponsor

Jabir Ibn Hayyan Medical University

Status

Completed

Last Update Posted

Jul 7, 2021Actual

Enrollment

228Actual

Phase

Not Applicable

Conditions

Inguinal Hernia

Interventions

polypropelene mesh

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

May 2021

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 2015Actual

Primary Completion Date

Feb 2018Actual

Completion Date

Feb 2020Actual

First Submitted Date

Mar 8, 2021

First Submission Date that Met QC Criteria

May 13, 2021

First Posted Date

May 18, 2021Actual

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

Jul 4, 2021

Last Update Posted Date

Jul 7, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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

A prospective randomized study involved 228 individuals with primary inguinal hernia, operated in our departments, between January 2015 to February 2018. The duration of hospital stay, operative time, duration of returning to routine activities, postsurgical sequels and recurrence rates estimated. We randomly allocated it into two groups: mesh repair was applied to 166 patients (Group 1) and combined both mesh, and darn repair applied to 162 patients (Group 2).

Detailed Description

Background In spite of the era of laparoscopy still, open repair in primary inguinal hernia is currently the most commonly performed general surgical operation. To evaluate whether the combined darn repair plus Lichtenstein compare Lichtenstein repair alone in the treatment of inguinal hernias regarding postoperative complication and recurrence.

Materials and methods:

A prospective randomized study involved with 218 patients with primary inguinal hernia, operated in our departments, between 2015 and 2018. The duration of the operation time, hospitalization, and time to return to daily activities and postoperative complication and recurrence rates were evaluated. We randomly allocated into two groups: Lichtenstein repair was applied to 169 patients (Group 1), and combined both modified darn repair plus Lichtenstein repair was applied to 160 patients (Group 2).

Results:

The average follow-up period was 48 months. For the alone Lichtenstein procedure, the average duration of operation was 62 min; the average time to return to routine activities was 21 days. The number of patients with postoperative complications was 12 (11.3 %), and the number of patients with recurrence was 1 (0. 9%). For darn repair plus Lichtenstein procedure, the average duration of operation was 72 min; the time to return to daily activities was 21days. The number of patients with postoperative complication was 13 (11.6%), and no recurrences were noted. The hospitalization time of the groups was similar.

Conclusion:

Two-year follow-up, combined mesh and darn better than mesh alone in recurrence rate, both had the same postoperative complication, hospitalization time and return to routine activity.

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

228Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group II MA Mesh alone repair	Active Comparator	patient use mesh alone as treatment of inguinal hernia	Procedure: polypropelene mesh
Group I CMD Combined Mesh & darn	Active Comparator	patients utilize both mesh and darn repair	Procedure: polypropelene mesh

Interventions

Name	Type	Description	Arm Group Labels	Other Names
polypropelene mesh	Procedure	compare use mesh alone or combined mesh and darn repair	Group I CMD Combined Mesh & darn Group II MA Mesh alone repair

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Recurrence rate	follow up	two to four year
Post operative complications	record complication	two to four year
Post operative pain	Visual Analog Score for pain	two to four year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

primary hernia
male

Exclusion Criteria:

Female
bilateral
recurrent hernia

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

70 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Yes

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

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