NCT05365087 - 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)

Barr AC, Frelich MJ, Bosler ME, Goldblatt MI, Gould JC
GERD and acid reduction medication use following gastric bypass and sleeve gastrectomy. Surg Endosc. 2017 Jan;31(1):410-415. doi: 10.1007/s00464-016-4989-4. Epub 2016 Jun 10.
DuPree CE, Blair K, Steele SR, Martin MJ
Laparoscopic sleeve gastrectomy in patients with preexisting gastroesophageal reflux disease : a national analysis. JAMA Surg. 2014 Apr;149(4):328-34. doi: 10.1001/jamasurg.2013.4323.
Rondelli F, Bugiantella W, Vedovati MC, Mariani E, Balzarotti Canger RC, Federici S, Guerra A, Boni M
Laparoscopic gastric bypass versus laparoscopic sleeve gastrectomy: A retrospective multicenter comparison between early and long-term post-operative outcomes. Int J Surg. 2017 Jan;37:36-41. doi: 10.1016/j.ijsu.2016.11.106. Epub 2016 Nov 29.
Tai CM, Huang CK
Increase in gastroesophageal reflux disease symptoms and erosive esophagitis 1 year after laparoscopic sleeve gastrectomy among obese adults. Surg Endosc. 2013 Oct;27(10):3937. doi: 10.1007/s00464-013-3022-4. Epub 2013 May 25. No abstract available.
Testoni PA, Testoni S, Mazzoleni G, Vailati C, Passaretti S
Long-term efficacy of transoral incisionless fundoplication with Esophyx (Tif 2.0) and factors affecting outcomes in GERD patients followed for up to 6 years: a prospective single-center study. Surg Endosc. 2015 Sep;29(9):2770-80. doi: 10.1007/s00464-014-4008-6. Epub 2014 Dec 6.
Trad KS, Turgeon DG, Deljkich E
Long-term outcomes after transoral incisionless fundoplication in patients with GERD and LPR symptoms. Surg Endosc. 2012 Mar;26(3):650-60. doi: 10.1007/s00464-011-1932-6. Epub 2011 Sep 30.

The Effect of Endoscopic Fundoplication Prior to Sleeve Gastrectomy Versus Gastric Bypass on Reflux Symptoms in Bariatric Patients With Gastroesophageal Reflux Disease

Details for clinical trial NCT05365087

Clinical trial NCT05365087 - References