NCT02453165 - 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)

Ceccaroni M, Berretta R, Malzoni M, Scioscia M, Roviglione G, Spagnolo E, Rolla M, Farina A, Malzoni C, De Iaco P, Minelli L, Bovicelli L
Vaginal cuff dehiscence after hysterectomy: a multicenter retrospective study. Eur J Obstet Gynecol Reprod Biol. 201
Hur HC, Donnellan N, Mansuria S, Barber RE, Guido R, Lee T
Vaginal cuff dehiscence after different modes of hysterectomy. Obstet Gynecol. 2011 Oct;118(4):794-801. doi: 10.1097/AOG.0b013e31822f1c92.
Kim MJ, Kim S, Bae HS, Lee JK, Lee NW, Song JY
Evaluation of risk factors of vaginal cuff dehiscence after hysterectomy. Obstet Gynecol Sci. 2014 Mar;57(2):136-43. doi: 10.5468/ogs.2014.57.2.136. Epub 2014 Mar 15.
Nieboer TE, Johnson N, Lethaby A, Tavender E, Curr E, Garry R, van Voorst S, Mol BW, Kluivers KB
Surgical approach to hysterectomy for benign gynaecological disease. Cochrane Database Syst Rev. 2009 Jul 8;(3):CD003677. doi: 10.1002/14651858.CD003677.pub4
Uccella S, Ceccaroni M, Cromi A, Malzoni M, Berretta R, De Iaco P, Roviglione G, Bogani G, Minelli L, Ghezzi F
Vaginal cuff dehiscence in a series of 12,398 hysterectomies: effect of different types of colpotomy and vaginal closure. Obstet Gynecol. 2012
Uccella S, Ghezzi F, Mariani A, Cromi A, Bogani G, Serati M, Bolis P
Vaginal cuff closure after minimally invasive hysterectomy: our experience and systematic review of the literature. Am J Obstet Gynecol. 2011 Aug;205(2):119.e1-12. doi: 10.1016/j.ajog.2

Randomized Clinical Trial About Vaginal Cuff Dehiscence Following Total Laparoscopic Hysterectomy: Laparoscopic vs. Transvaginal Cuff Suturing

Clinical trial NCT02453165 - References