NCT04138329 - Clinical Trial References

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.

Citation(s)

Aasvang E, Kehlet H
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Alfieri S, Amid PK, Campanelli G, Izard G, Kehlet H, Wijsmuller AR, Di Miceli D, Doglietto GB
International guidelines for prevention and management of post-operative chronic pain following inguinal hernia surgery. Hernia. 2011 Jun;15(3):239-49. doi: 10.1007/s10029-011-0798-9. Epub 2011 Mar 2.
Andresen K, Burcharth J, Fonnes S, Hupfeld L, Rothman JP, Deigaard S, Winther D, Errebo MB, Therkildsen R, Hauge D, Sørensen FS, Bjerg J, Rosenberg J
Chronic pain after inguinal hernia repair with the ONSTEP versus the Lichtenstein technique, results of a double-blinded multicenter randomized clinical trial. Langenbecks Arch Surg. 2017 Mar;402(2):213-218. doi: 10.1007/s00423-016-1532-y. Epub 2016 Nov 11.
Browne RH
On the use of a pilot sample for sample size determination. Stat Med. 1995 Sep 15;14(17):1933-40.
Fränneby U, Gunnarsson U, Andersson M, Heuman R, Nordin P, Nyrén O, Sandblom G
Validation of an Inguinal Pain Questionnaire for assessment of chronic pain after groin hernia repair. Br J Surg. 2008 Apr;95(4):488-93.
Lourenço A, da Costa RS
The ONSTEP inguinal hernia repair technique: initial clinical experience of 693 patients, in two institutions. Hernia. 2013 Jun;17(3):357-64. doi: 10.1007/s10029-013-1057-z. Epub 2013 Feb 24.
Rosenberg J, Andresen K
The Onstep Method for Inguinal Hernia Repair: Operative Technique and Technical Tips. Surg Res Pract. 2016;2016:6935167. doi: 10.1155/2016/6935167. Epub 2016 Jun 9. Review.

Comparison of Postoperative Inguinal Pain Between the Onstep Technique and the Lichtenstein Technique: A Randomized Controlled Study.

Details for clinical trial NCT04138329

Clinical trial NCT04138329 - References