NCT03766061

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

July 13, 2018

Completed
5 months until next milestone

First Posted

Study publicly available on registry

December 5, 2018

Completed
Last Updated

February 1, 2019

Status Verified

January 1, 2019

Enrollment Period

1.5 years

First QC Date

July 13, 2018

Last Update Submit

January 30, 2019

Conditions

Paraumbilical Hernia

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Postoperative pain from score 1 to 10

    3 days

  • Hospital Stay duration in days

    1 week

Study Arms (2)

Onlay Mesh Hernioplasty

ACTIVE COMPARATOR

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

Sublay Mesh Hernioplasty

ACTIVE COMPARATOR

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

Interventions

Onlay mesh HernioplastyPROCEDURE

Patients with paraumblical hernia are treated with onlay mesh hernioplasty in which mesh is placed on anterior rectus sheath

Onlay Mesh Hernioplasty
Sublay Mesh HernioplastyPROCEDURE

Patients with paraumblical hernia are treated with sublay mesh hernioplasty in which mesh is placed in retromuscular space

Sublay Mesh Hernioplasty

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients of both sexes and age 20 years and above with paraumblical hernia Defect size 3 to 6cm in greatest diameter

You may not qualify if:

  • defect size less than 3cm or greater than 6 cm in greatest diameter Obstructed or strangulated hernia Uncontrolled diabetes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Services hospital

Lahore, Punjab Province, 54000, Pakistan

Location

Study Officials

  • Mahmmood Ayyaz, mbbs, fcps

    Services Hospital, Lahore

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle investigator

Study Record Dates

First Submitted

July 13, 2018

First Posted

December 5, 2018

Study Start

January 1, 2017

Primary Completion

July 1, 2018

Study Completion

July 1, 2018

Last Updated

February 1, 2019

Record last verified: 2019-01

Locations

PA(1)