Evaluation of Postoperative Pain Following Laparoscopic Hernia Repair

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by Covidien.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Covidien
ClinicalTrials.gov Identifier:
NCT00749268
First received: September 8, 2008
Last updated: June 14, 2012
Last verified: June 2012
  Purpose

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.


Condition Intervention Phase
Hernia, Inguinal
Hernia, Ventral
Device: AbsorbaTack
Device: ProTack
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of Postoperative Pain Following Laparoscopic Hernia Repair

Resource links provided by NLM:


Further study details as provided by Covidien:

Primary Outcome Measures:
  • Postoperative Pain [ Time Frame: four time points out to one year ] [ Designated as safety issue: No ]
  • Safety for laparoscopic hernia repair as measured by device related events [ Time Frame: four time points out to one year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Quality of life/ time to return to normal activity [ Time Frame: three time points out to one year ] [ Designated as safety issue: No ]
  • Hernia recurrence [ Time Frame: four time points out to one year ] [ Designated as safety issue: No ]

Estimated Enrollment: 371
Study Start Date: October 2008
Estimated Study Completion Date: October 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A Device: AbsorbaTack
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.
Active Comparator: B Device: ProTack
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00749268

Locations
United States, Ohio
University Hospitals at Case Medical Center
Cleveland, Ohio, United States, 44194
United States, South Carolina
Greenville Hospital System
Greenville, South Carolina, United States, 29605
Sponsors and Collaborators
Covidien
  More Information

No publications provided

Responsible Party: Covidien
ClinicalTrials.gov Identifier: NCT00749268     History of Changes
Other Study ID Numbers: AS08011
Study First Received: September 8, 2008
Last Updated: June 14, 2012
Health Authority: United States: Institutional Review Board
France: Institutional Ethical Committee
Germany: Ethics Commission

Keywords provided by Covidien:
hernia

Additional relevant MeSH terms:
Hernia
Pain, Postoperative
Hernia, Inguinal
Hernia, Ventral
Pathological Conditions, Anatomical
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Hernia, Abdominal

ClinicalTrials.gov processed this record on September 16, 2014