Prevention of Parastomal Hernia by Mesh Placement

Parastomal Hernia Clinical Trial

Official title:

A Randomized Study of the Utility of Composite Mesh Placement to Prevent Parastomal Hernia in Patients Undergoing Urinary Diversion With Ileal Conduit

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02404545
• Other study ID #: 20140277
• Status: Terminated
• Phase: N/A
• First received: March 26, 2015
• Last updated: August 24, 2017
• Start date: August 14, 2015
• Est. completion date: March 2017

Study information

• Verified date: August 2017
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Concurrent placement of a mesh during formation of ileal conduit will decrease the incidence of parastomal hernia and associated complications.

Description:

Subject to inclusion and exclusion criteria, patients will be randomized 1:1 to the control and intervention groups:

Randomization groups:

• Group 1 (control): Ileal Conduit

• Group 2 (intervention): Ileal conduit with concurrent mesh placement.

Ethicon PHYSIOMESH composite mesh will be utilized for this study. This is a composite mesh with a reduced polypropylene content. It is a widely used, commercially available hernia mesh, and its use and placement are simple and well described. The mesh will be placed at the time of radical cystectomy and ileal conduit. A small circle of mesh, the diameter of the ileal conduit, will be excised to allow for fitment around the ileal conduit. The mesh will be placed so that it encompasses the ileal conduit in a non-constricting manner, and will be sutured to the anterior abdominal wall. Product will be stored in a secure, sterile manner at the UMH operating room sterile supply room, and in accordance with institutional policies.

Patients from both groups will be followed up in a standard fashion. Follow up visits and clinical assessment will be at 6 weeks after surgery, 3 monthly during the first year, then every 6 months for at least 5 years. During each visit, patients will be clinically evaluated for the presence or absence of parastomal hernia, and any routine surveillance radiology imaging will be reviewed.

Parastomal hernia is clinically defined as an incisional hernia at the site of the ileal conduit stoma. This may be clinically apparent by examining the patient during performance of abdominal straining or Valsalva maneuver, or may be evident on radiology imaging.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: March 2017
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Patients eligible to undergo urinary diversion with ileal conduit.

2. Patients with the ability to understand and willingness to sign a written informed consent document.

3. Men and Women aged 18 to 80 years.

Exclusion Criteria:

1. Patients unable or unwilling to consent to the proposed surgery

2. Pregnant women

3. Patients with prior ileal conduit surgery undergoing revision.

Related Conditions & MeSH terms

• Hernia
• Parastomal Hernia

Intervention

Device:
• Ethicon Physiomesh
Ethicon Physiomesh will be paced at the time of radical cystectomy and ileal conduit.

Locations

Country	Name	City	State
United States	University Of Miami	Miami	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Miami	Ethicon, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (16)

Carne PW, Robertson GM, Frizelle FA. Parastomal hernia. Br J Surg. 2003 Jul;90(7):784-93. Review. — View Citation

Cheung MT, Chia NH, Chiu WY. Surgical treatment of parastomal hernia complicating sigmoid colostomies. Dis Colon Rectum. 2001 Feb;44(2):266-70. — View Citation

Etherington RJ, Williams JG, Hayward MW, Hughes LE. Demonstration of para-ileostomy herniation using computed tomography. Clin Radiol. 1990 May;41(5):333-6. — View Citation

Hammond TM, Huang A, Prosser K, Frye JN, Williams NS. Parastomal hernia prevention using a novel collagen implant: a randomised controlled phase 1 study. Hernia. 2008 Oct;12(5):475-81. doi: 10.1007/s10029-008-0383-z. Epub 2008 May 17. — View Citation

Israelsson LA. Parastomal hernias. Surg Clin North Am. 2008 Feb;88(1):113-25, ix. doi: 10.1016/j.suc.2007.10.003. Review. — View Citation

Israelsson LA. Preventing and treating parastomal hernia. World J Surg. 2005 Aug;29(8):1086-9. Review. — View Citation

Jänes A, Cengiz Y, Israelsson LA. Preventing parastomal hernia with a prosthetic mesh: a 5-year follow-up of a randomized study. World J Surg. 2009 Jan;33(1):118-21; discussion 122-3. doi: 10.1007/s00268-008-9785-4. — View Citation

Kouba E, Sands M, Lentz A, Wallen E, Pruthi RS. Incidence and risk factors of stomal complications in patients undergoing cystectomy with ileal conduit urinary diversion for bladder cancer. J Urol. 2007 Sep;178(3 Pt 1):950-4. Epub 2007 Jul 16. — View Citation

Marimuthu K, Vijayasekar C, Ghosh D, Mathew G. Prevention of parastomal hernia using preperitoneal mesh: a prospective observational study. Colorectal Dis. 2006 Oct;8(8):672-5. — View Citation

Martin L, Foster G. Parastomal hernia. Ann R Coll Surg Engl. 1996 Mar;78(2):81-4. Review. — View Citation

Pastor DM, Pauli EM, Koltun WA, Haluck RS, Shope TR, Poritz LS. Parastomal hernia repair: a single center experience. JSLS. 2009 Apr-Jun;13(2):170-5. — View Citation

Pearl RK. Parastomal hernias. World J Surg. 1989 Sep-Oct;13(5):569-72. — View Citation

Rubin MS, Schoetz DJ Jr, Matthews JB. Parastomal hernia. Is stoma relocation superior to fascial repair? Arch Surg. 1994 Apr;129(4):413-8; discussion 418-9. — View Citation

Serra-Aracil X, Bombardo-Junca J, Moreno-Matias J, Darnell A, Mora-Lopez L, Alcantara-Moral M, Ayguavives-Garnica I, Navarro-Soto S. Randomized, controlled, prospective trial of the use of a mesh to prevent parastomal hernia. Ann Surg. 2009 Apr;249(4):583 — View Citation

Shabbir J, Chaudhary BN, Dawson R. A systematic review on the use of prophylactic mesh during primary stoma formation to prevent parastomal hernia formation. Colorectal Dis. 2012 Aug;14(8):931-6. doi: 10.1111/j.1463-1318.2011.02835.x. Review. — View Citation

Stephenson BM, Phillips RK. Parastomal hernia: local resiting and mesh repair. Br J Surg. 1995 Oct;82(10):1395-6. — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of Reduction of the Incidence of Parastomal Hernia	Rate of reduction of the incidence of parastomal hernia in study participants, as assessed by physical examination	18 months
Secondary	Number of Participants Who Develop Mesh Related Complications	Assessed by physical examination including: Mesh erosion and infection; Stomal stenosis and necrosis; Frequency of stoma pouch appliance changes.; Record by physical exam the incidence of parastomal hernia at 5 years.	60 months