NCT03972553 - 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)

Carne PW, Robertson GM, Frizelle FA
Parastomal hernia. Br J Surg. 2003 Jul;90(7):784-93. doi: 10.1002/bjs.4220.
De Raet J, Delvaux G, Haentjens P, Van Nieuwenhove Y
Waist circumference is an independent risk factor for the development of parastomal hernia after permanent colostomy. Dis Colon Rectum. 2008 Dec;51(12):1806-9. doi: 10.1007/s10350-008-9366-5. Epub 2008 May 16.
Gavigan T, Stewart T, Matthews B, Reinke C
Patients Undergoing Parastomal Hernia Repair Using the Americas Hernia Society Quality Collaborative: A Prospective Cohort Study. J Am Coll Surg. 2018 Oct;227(4):393-403.e1. doi: 10.1016/j.jamcollsurg.2018.07.658. Epub 2018 Aug 4.
Hotouras A, Murphy J, Thaha M, Chan CL
The persistent challenge of parastomal herniation: a review of the literature and future developments. Colorectal Dis. 2013 May;15(5):e202-14. doi: 10.1111/codi.12156.
Raigani S, Criss CN, Petro CC, Prabhu AS, Novitsky YW, Rosen MJ
Single-center experience with parastomal hernia repair using retromuscular mesh placement. J Gastrointest Surg. 2014 Sep;18(9):1673-7. doi: 10.1007/s11605-014-2575-4. Epub 2014 Jun 19.
Timmermans L, Deerenberg EB, Lamme B, Jeekel J, Lange JF
Parastomal hernia is an independent risk factor for incisional hernia in patients with end colostomy. Surgery. 2014 Jan;155(1):178-83. doi: 10.1016/j.surg.2013.06.014. Epub 2013 Nov 12.
Turnbull GB
Ostomy statistics: the $64,000 question. Ostomy Wound Manage. 2003 Jun;49(6):22-3. No abstract available.

Parastomal Hernia Repair Utilizing the Retromuscular Sugarbaker Versus Keyhole Mesh Techniques: A Registry-Based Randomized Controlled Trial

Clinical trial NCT03972553 - References