NCT00749268

Brief Summary

The objective of this study is to assess pain that occurs following hernia repair that is related to mesh fixation. The study is designed to see if there is any difference in pain after surgery between absorbable and permanent methods of mesh fixation in inguinal and ventral hernia repair.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
216

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Oct 2008

Longer than P75 for phase_4

Geographic Reach
1 country

2 active sites

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

First Submitted

Initial submission to the registry

September 8, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 9, 2008

Completed
22 days until next milestone

Study Start

First participant enrolled

October 1, 2008

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
2.9 years until next milestone

Results Posted

Study results publicly available

October 5, 2015

Completed
Last Updated

October 5, 2015

Status Verified

September 1, 2015

Enrollment Period

3.2 years

First QC Date

September 8, 2008

Results QC Date

October 14, 2013

Last Update Submit

September 9, 2015

Conditions

Hernia, InguinalHernia, Ventral

Keywords

hernia

Outcome Measures

Primary Outcomes (2)

  • Postoperative Pain

    Pain Intensity Numeric Rating Scale (PI-NRS) - change from baseline. Treatments analyzed within inguinal arm and within ventral arm. Scale is 0 - 10 with 0 being "no pain" and 10 being "worst pain imaginable".

    Discharge, Month 1, Month 6, Month 12

  • Safety for Laparoscopic Hernia Repair as Measured by Number of Patients Experiencing Device Related Events

    One year

Secondary Outcomes (2)

  • Quality of Life

    Pre-op, Month 1, Month 6, 1 year

  • Hernia Recurrence

    Discharge, 1 Month, 6 Month, 1 year

Study Arms (2)

A

ACTIVE COMPARATOR
Device: AbsorbaTack

B

ACTIVE COMPARATOR
Device: ProTack

Interventions

AbsorbaTackDEVICE

Comparison of different devices for mesh fixation. This intervention arm has absorbable tacks as the method of hernia mesh fixation. Application is during hernia repair and tacks will essentially absorb within the body after 1 year.

A
ProTackDEVICE

Comparison of different devices for mesh fixation. This intervention is a permanent tack for hernia mesh fixation. Application is during hernia repair and the tacks will remain in the body.

B

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Ability and willingness to provide written informed consent and comply with the schedule of protocol assessments
  • Age \> 18 years
  • Subjects undergoing laparoscopic hernia repair with Parietex or Parietex Composite reinforcements depending on indication and fixation of reinforcements with helical tackers (ProTack, Covidien) or absorbable tacks (AbsorbaTack, Covidien) in accordance with recommendations for use

You may not qualify if:

  • Pregnancy
  • Patients considered to have greater than reasonable surgical risk associated with general anesthesia and laparoscopic hernia repair
  • Known active infection or any major episode of infection requiring hospitalization or treatment with IV antibiotics or oral antibiotics within 30 days prior to screening
  • History of alcohol or drug abuse within 6 months prior to screening
  • History of chronic pain condition requiring more than 30 days of medical management
  • Use of an additional nonresorbable means of fixation (inguinal)
  • Patients considered not able to comply with the protocol and follow up schedule
  • ASA grade of 4 or above

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University Hospitals at Case Medical Center

Cleveland, Ohio, 44194, United States

Location

Greenville Hospital System

Greenville, South Carolina, 29605, United States

Location

MeSH Terms

Conditions

Hernia, InguinalHernia, VentralHernia

Condition Hierarchy (Ancestors)

Hernia, AbdominalPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Jessica Carlson, Clinical Project Manager
Organization
Covidien
jessica.carlson@covidien.com
(203) 821-4734

Study Officials

  • M Rosen

    Case Medical Center, University Hospitals of Cleveland, Cleveland, OH, USA

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 8, 2008

First Posted

September 9, 2008

Study Start

October 1, 2008

Primary Completion

December 1, 2011

Study Completion

November 1, 2012

Last Updated

October 5, 2015

Results First Posted

October 5, 2015

Record last verified: 2015-09

Locations

US(2)