Status:
COMPLETED
AbsorbaTack Evaluation of Postoperative Pain Following Laparoscopic Hernia Repair
Lead Sponsor:
Medtronic - MITG
Conditions:
Hernia, Inguinal
Hernia, Ventral
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 betwee...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2012
Estimated Enrollment :
216 Patients enrolled
Trial Details
Trial ID
NCT00749268
Start Date
October 1 2008
End Date
November 1 2012
Last Update
October 5 2015
Active Locations (2)
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1
University Hospitals at Case Medical Center
Cleveland, Ohio, United States, 44194
2
Greenville Hospital System
Greenville, South Carolina, United States, 29605