Ventral Hernia — LACH-Trial: LAparoscopic Correction of Hernia
Citation(s)
DeMaria EJ, Moss JM, Sugerman HJ Laparoscopic intraperitoneal polytetrafluoroethylene (PTFE) prosthetic patch repair of ventral hernia. Prospective comparison to open prefascial polypropylene mesh repair. Surg Endosc. 2000 Apr;14(4):326-9.
Goodney PP, Birkmeyer CM, Birkmeyer JD Short-term outcomes of laparoscopic and open ventral hernia repair: a meta-analysis. Arch Surg. 2002 Oct;137(10):1161-5.
Heniford BT, Park A, Ramshaw BJ, Voeller G Laparoscopic repair of ventral hernias: nine years' experience with 850 consecutive hernias. Ann Surg. 2003 Sep;238(3):391-9; discussion 399-400.
LeBlanc KA Laparoscopic incisional and ventral hernia repair: complications-how to avoid and handle. Hernia. 2004 Dec;8(4):323-31. Review.
The Effect of Mesh Fixation Technique on Postoperative Pain in Laparoscopic Correction of Incisional and Ventral Abdominal Wall Hernias.
Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.
Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.
Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.
Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.
Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.