Onlay Mesh Hernioplasty Vs Sublay Mesh Hernioplasty for Paraumbilical Hernia Repair

Paraumbilical Hernia Clinical Trial

Official title:

Onlay Mesh Hernioplasty Vs Sublay Mesh Hernioplasty for Paraumbilical Hernia Repair

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03766061
• Other study ID #: s8
• Status: Completed
• Phase: N/A
• Start date: January 1, 2017
• Est. completion date: July 1, 2018

Study information

• Verified date: January 2019
• Source: Services Hospital, Lahore
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

It is a randomized controlled trial in which we are comparing onlay mesh hernioplasty with sublay mesh hernioplasty for paraumbilical hernia.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: July 1, 2018
• Est. primary completion date: July 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Hernia
• Paraumbilical Hernia

Intervention

Procedure:
• Onlay mesh Hernioplasty
Patients with paraumblical hernia are treated with onlay mesh hernioplasty in which mesh is placed on anterior rectus sheath
• Sublay Mesh Hernioplasty
Patients with paraumblical hernia are treated with sublay mesh hernioplasty in which mesh is placed in retromuscular space

Locations

Country	Name	City	State
Pakistan	Services hospital	Lahore	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Services Hospital, Lahore

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	8 months
Secondary	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	3 days
Secondary	Hospital Stay duration in days	hospital stay (duration of patient from surgery to discharge) after surgery	1 week