AbsorbaTack Evaluation of Postoperative Pain Following Laparoscopic Hernia Repair
Completed · Phase 4
Conditions studied: Hernia, Inguinal, Hernia, Ventral
In brief
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.
Key facts
- Study ID
- NCT00749268
- Run by
- Medtronic - MITG
- People needed
- 216
- Starts
- 2008-10-01
- Expected to finish
- 2012-11-01
- Last updated by the study team
- 2015-10-05
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
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
Where it is running
- University Hospitals at Case Medical Center — Cleveland, Ohio, United States
- Greenville Hospital System — Greenville, South Carolina, United States
Full record on ClinicalTrials.gov
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