Mesh Alone VS Combined Mesh and Darn in the Management of Primary Inguinal Hernia in Adult Males
Primary Purpose
Inguinal Hernia
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
polypropelene mesh
Sponsored by
About this trial
This is an interventional treatment trial for Inguinal Hernia focused on measuring Adult inguinal hernia, Mesh, Darn repair, Hernia repair techinques, Primary inguinal hernia
Eligibility Criteria
Inclusion Criteria:
- primary hernia
- male
Exclusion Criteria:
- Female
- bilateral
- recurrent hernia
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Group II MA Mesh alone repair
Group I CMD Combined Mesh & darn
Arm Description
patient use mesh alone as treatment of inguinal hernia
patients utilize both mesh and darn repair
Outcomes
Primary Outcome Measures
Recurrence rate
follow up
Post operative complications
record complication
Post operative pain
Visual Analog Score for pain
Secondary Outcome Measures
Full Information
NCT ID
NCT04891601
First Posted
March 8, 2021
Last Updated
July 4, 2021
Sponsor
Jabir Ibn Hayyan Medical University
1. Study Identification
Unique Protocol Identification Number
NCT04891601
Brief Title
Mesh Alone VS Combined Mesh and Darn in the Management of Primary Inguinal Hernia in Adult Males
Official Title
Randomised Controlled Trial, Compare Mesh and Combined Mesh and Darn Repair in the Treatment of Adults Inguinal Hernia
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
January 2015 (Actual)
Primary Completion Date
February 2018 (Actual)
Study Completion Date
February 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jabir Ibn Hayyan Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inguinal Hernia
Keywords
Adult inguinal hernia, Mesh, Darn repair, Hernia repair techinques, Primary inguinal hernia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
228 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group II MA Mesh alone repair
Arm Type
Active Comparator
Arm Description
patient use mesh alone as treatment of inguinal hernia
Arm Title
Group I CMD Combined Mesh & darn
Arm Type
Active Comparator
Arm Description
patients utilize both mesh and darn repair
Intervention Type
Procedure
Intervention Name(s)
polypropelene mesh
Intervention Description
compare use mesh alone or combined mesh and darn repair
Primary Outcome Measure Information:
Title
Recurrence rate
Description
follow up
Time Frame
two to four year
Title
Post operative complications
Description
record complication
Time Frame
two to four year
Title
Post operative pain
Description
Visual Analog Score for pain
Time Frame
two to four year
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
primary hernia
male
Exclusion Criteria:
Female
bilateral
recurrent hernia
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
Yes
Learn more about this trial
Mesh Alone VS Combined Mesh and Darn in the Management of Primary Inguinal Hernia in Adult Males
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