Onlay Mesh Hernioplasty Vs Sublay Mesh Hernioplasty for Paraumbilical Hernia Repair

January 30, 2019 updated by: Dr. SamiUllah, Services Hospital, Lahore
It is a randomized controlled trial in which we are comparing onlay mesh hernioplasty with sublay mesh hernioplasty for paraumbilical hernia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab
      • Lahore, Punjab, Pakistan, 54000
        • Services Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 58 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Onlay Mesh Hernioplasty
In this group patients with paraumbilical hernia are treated with onlay mesh hernioplasty in which we placed mesh on the anterior rectus sheath
Procedure: Onlay mesh Hernioplasty
Patients with paraumblical hernia are treated with onlay mesh hernioplasty in which mesh is placed on anterior rectus sheath
Active Comparator: Sublay Mesh Hernioplasty
In this group patients with paraumbilical hernia are treated with sublay mesh hernioplasty in which we placed mesh in the retromuscular space
Procedure: Sublay Mesh Hernioplasty
Patients with paraumblical hernia are treated with sublay mesh hernioplasty in which mesh is placed in retromuscular space

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of patients presenting with recurrence of hernia
Time Frame: 8 months
Recurrence (defined as appearance of swelling in operative site with positive cough impulse) of hernia after surgery
8 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative pain from score 1 to 10
Time Frame: 3 days
Postoperative pain measured with visual analog score after surgery with 1 being the minimum and 10 being the maximum
3 days
Hospital Stay duration in days
Time Frame: 1 week
hospital stay (duration of patient from surgery to discharge) after surgery
1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Services Hospital, Lahore

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2017

Primary Completion (Actual)

July 1, 2018

Study Completion (Actual)

July 1, 2018

Study Registration Dates

First Submitted

July 13, 2018

First Submitted That Met QC Criteria

December 4, 2018

First Posted (Actual)

December 5, 2018

Study Record Updates

Last Update Posted (Actual)

February 1, 2019

Last Update Submitted That Met QC Criteria

January 30, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S8

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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