NCT06225609 - 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)

Lee L, de Lacy B, Gomez Ruiz M, Liberman AS, Albert MR, Monson JRT, Lacy A, Kim SH, Atallah SB
A Multicenter Matched Comparison of Transanal and Robotic Total Mesorectal Excision for Mid and Low-rectal Adenocarcinoma. Ann Surg. 2019 Dec;270(6):1110-1116. doi: 10.1097/SLA.0000000000002862.
Miccini M, Amore Bonapasta S, Gregori M, Barillari P, Tocchi A
Ghost ileostomy: real and potential advantages. Am J Surg. 2010 Oct;200(4):e55-7. doi: 10.1016/j.amjsurg.2009.12.017.
Mori L, Vita M, Razzetta F, Meinero P, D'Ambrosio G
Ghost ileostomy in anterior resection for rectal carcinoma: is it worthwhile? Dis Colon Rectum. 2013 Jan;56(1):29-34. doi: 10.1097/DCR.0b013e3182716ca1.
Palumbo P, Usai S, Pansa A, Lucchese S, Caronna R, Bona S
Anastomotic Leakage in Rectal Surgery: Role of the Ghost Ileostomy. Anticancer Res. 2019 Jun;39(6):2975-2983. doi: 10.21873/anticanres.13429.
Roodbeen SX, Penna M, Mackenzie H, Kusters M, Slater A, Jones OM, Lindsey I, Guy RJ, Cunningham C, Hompes R
Transanal total mesorectal excision (TaTME) versus laparoscopic TME for MRI-defined low rectal cancer: a propensity score-matched analysis of oncological outcomes. Surg Endosc. 2019 Aug;33(8):2459-2467. doi: 10.1007/s00464-018-6530-4. Epub 2018 Oct 22.
Zhao S, Zhang L, Gao F, Wu M, Zheng J, Bai L, Li F, Liu B, Pan Z, Liu J, Du K, Zhou X, Li C, Zhang A, Pu Z, Li Y, Feng B, Tong W
Transanal Drainage Tube Use for Preventing Anastomotic Leakage After Laparoscopic Low Anterior Resection in Patients With Rectal Cancer: A Randomized Clinical Trial. JAMA Surg. 2021 Dec 1;156(12):1151-1158. doi: 10.1001/jamasurg.2021.4568.

Ghost Ileostomy Group Versus no Stoma Group in Patients Undergoing Total Mesorectal Excision for Rectal Cancer: A Randomized Controlled Study

Details for clinical trial NCT06225609

Clinical trial NCT06225609 - References