NCT01638221

Brief Summary

This study will be comparing the patients overall satisfaction of two different meshes used in laparoscopic inguinal hernia repairs.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

July 1, 2012

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

July 9, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 11, 2012

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
Last Updated

August 1, 2012

Status Verified

July 1, 2012

Enrollment Period

1 year

First QC Date

July 9, 2012

Last Update Submit

July 31, 2012

Conditions

Inguinal Hernia

Outcome Measures

Primary Outcomes (1)

  • pain

    Subjective pain scale rating post surgical

    1 year

Secondary Outcomes (1)

  • return to activities of daily living

    1 year

Study Arms (2)

heavy weight mesh

Surgipro mesh is a heavier weighted mesh with less flexibility after surgery

light weight mesh

UltraPro mesh is a lighter weighted mesh with theoretically less stiffness and more flexibility compared to heavier weighted meshes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients over the age of 18 who are undergoing a unilateral repair of inguinal hernias laparoscopically

You may qualify if:

  • over the age of 18
  • unilateral side to be repaired
  • no major abdominal surgery previously

You may not qualify if:

  • under age 18
  • bilateral repairs undertaken

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

GenesysRMC

Grand Blanc, Michigan, 48439, United States

RECRUITING

MeSH Terms

Conditions

Hernia, Inguinal

Condition Hierarchy (Ancestors)

Hernia, AbdominalHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Adam P Pentel, DO

    Ascension Health

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Adam P Pentel, DO

CONTACT

402-720-5871apentel@hotmail.com

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
DO, general surgery resident

Study Record Dates

First Submitted

July 9, 2012

First Posted

July 11, 2012

Study Start

July 1, 2012

Primary Completion

July 1, 2013

Last Updated

August 1, 2012

Record last verified: 2012-07

Locations

US(1)