Back to resultsOnlay Mesh Hernioplasty Vs Sublay Mesh Hernioplasty for Paraumbilical Hernia Repair
Primary Purpose
Paraumbilical Hernia
Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Onlay mesh Hernioplasty
Sublay Mesh Hernioplasty
Sponsored by
About this trial
This is an interventional treatment trial for Paraumbilical Hernia
Eligibility Criteria
Inclusion Criteria:
- Patients of both sexes and age 20 years and above with paraumblical hernia Defect size 3 to 6cm in greatest diameter
Exclusion Criteria:
- defect size less than 3cm or greater than 6 cm in greatest diameter Obstructed or strangulated hernia Uncontrolled diabetes
Sites / Locations
- Services hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Onlay Mesh Hernioplasty
Sublay Mesh Hernioplasty
Arm Description
In this group patients with paraumbilical hernia are treated with onlay mesh hernioplasty in which we placed mesh on the anterior rectus sheath
In this group patients with paraumbilical hernia are treated with sublay mesh hernioplasty in which we placed mesh in the retromuscular space
Outcomes
Primary Outcome Measures
Percentage of patients presenting with recurrence of hernia
Recurrence (defined as appearance of swelling in operative site with positive cough impulse) of hernia after surgery
Secondary Outcome Measures
Postoperative pain from score 1 to 10
Postoperative pain measured with visual analog score after surgery with 1 being the minimum and 10 being the maximum
Hospital Stay duration in days
hospital stay (duration of patient from surgery to discharge) after surgery
Full Information
NCT ID
NCT03766061
First Posted
July 13, 2018
Last Updated
January 30, 2019
Sponsor
Services Hospital, Lahore
1. Study Identification
Unique Protocol Identification Number
NCT03766061
Brief Title
Onlay Mesh Hernioplasty Vs Sublay Mesh Hernioplasty for Paraumbilical Hernia Repair
Official Title
Onlay Mesh Hernioplasty Vs Sublay Mesh Hernioplasty for Paraumbilical Hernia Repair
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
January 1, 2017 (Actual)
Primary Completion Date
July 1, 2018 (Actual)
Study Completion Date
July 1, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Services Hospital, Lahore
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
It is a randomized controlled trial in which we are comparing onlay mesh hernioplasty with sublay mesh hernioplasty for paraumbilical hernia.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Paraumbilical Hernia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Onlay Mesh Hernioplasty
Arm Type
Active Comparator
Arm Description
In this group patients with paraumbilical hernia are treated with onlay mesh hernioplasty in which we placed mesh on the anterior rectus sheath
Arm Title
Sublay Mesh Hernioplasty
Arm Type
Active Comparator
Arm Description
In this group patients with paraumbilical hernia are treated with sublay mesh hernioplasty in which we placed mesh in the retromuscular space
Intervention Type
Procedure
Intervention Name(s)
Onlay mesh Hernioplasty
Intervention Description
Patients with paraumblical hernia are treated with onlay mesh hernioplasty in which mesh is placed on anterior rectus sheath
Intervention Type
Procedure
Intervention Name(s)
Sublay Mesh Hernioplasty
Intervention Description
Patients with paraumblical hernia are treated with sublay mesh hernioplasty in which mesh is placed in retromuscular space
Primary Outcome Measure Information:
Title
Percentage of patients presenting with recurrence of hernia
Description
Recurrence (defined as appearance of swelling in operative site with positive cough impulse) of hernia after surgery
Time Frame
8 months
Secondary Outcome Measure Information:
Title
Postoperative pain from score 1 to 10
Description
Postoperative pain measured with visual analog score after surgery with 1 being the minimum and 10 being the maximum
Time Frame
3 days
Title
Hospital Stay duration in days
Description
hospital stay (duration of patient from surgery to discharge) after surgery
Time Frame
1 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients of both sexes and age 20 years and above with paraumblical hernia Defect size 3 to 6cm in greatest diameter
Exclusion Criteria:
defect size less than 3cm or greater than 6 cm in greatest diameter Obstructed or strangulated hernia Uncontrolled diabetes
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mahmmood Ayyaz, mbbs, fcps
Organizational Affiliation
Services Hospital, Lahore
Official's Role
Study Director
Facility Information:
Facility Name
Services hospital
City
Lahore
State/Province
Punjab
ZIP/Postal Code
54000
Country
Pakistan
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Onlay Mesh Hernioplasty Vs Sublay Mesh Hernioplasty for Paraumbilical Hernia Repair
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