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| Name | Class |
|---|---|
| Ethicon, Inc. | INDUSTRY |
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Concurrent placement of a mesh during formation of ileal conduit will decrease the incidence of parastomal hernia and associated complications.
Subject to inclusion and exclusion criteria, patients will be randomized 1:1 to the control and intervention groups:
Randomization groups:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 - Ideal Conduit No Mesh | No Intervention | No mesh will be placed at the time of radical cystectomy and ileal conduit. | |
| Group 2 - Ileal Conduit with Mesh | Active Comparator | Ethicon Physiomesh will be placed at the time of radical cystectomy and ileal conduit. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ethicon Physiomesh | Device | Ethicon Physiomesh will be paced at the time of radical cystectomy and ileal conduit. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Develop Mesh Related Complications | Assessed by physical examination including:
| 60 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Murugesan Manoharan, MD | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Of Miami | Miami | Florida | 33136 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12854101 | Result | Carne PW, Robertson GM, Frizelle FA. Parastomal hernia. Br J Surg. 2003 Jul;90(7):784-93. doi: 10.1002/bjs.4220. | |
| 15981038 | Result | Israelsson LA. Preventing and treating parastomal hernia. World J Surg. 2005 Aug;29(8):1086-9. doi: 10.1007/s00268-005-7973-z. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1 - Ideal Conduit No Mesh | No mesh will be placed at the time of radical cystectomy and ileal conduit. |
| FG001 | Group 2 - Ileal Conduit With Mesh | Ethicon Physiomesh will be placed at the time of radical cystectomy and ileal conduit. Ethicon Physiomesh: Ethicon Physiomesh will be paced at the time of radical cystectomy and ileal conduit. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1 - Ideal Conduit No Mesh | No mesh will be placed at the time of radical cystectomy and ileal conduit. |
| BG001 | Group 2 - Ileal Conduit With Mesh | Ethicon Physiomesh will be placed at the time of radical cystectomy and ileal conduit. Ethicon Physiomesh: Ethicon Physiomesh will be paced at the time of radical cystectomy and ileal conduit. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | The study required a minimum of 13 participants enrolled per arm for analysis of this outcome measure. Due to the manufacturer's (Ethicon) termination of the Physiomesh device, the study was prematurely terminated with fewer than minimum number of participants required on each arm, and the data were not analyzed. | Posted | 18 months |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group 1 - Ideal Conduit No Mesh | No mesh will be placed at the time of radical cystectomy and ileal conduit. |
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This study required a minimum of 13 participants enrolled per arm. Due to the manufacturer's (Ethicon) termination of the Physiomesh device, the study was prematurely closed with fewer than minimum number of participants required per arm.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Murugesan Manoharan MD, FRCS (Eng), FRACS (Urol) | Baptist Health South Florida - Miami Cancer Institute | 305-595-2141 | mmanoharan@baptisthealth.net |
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| ID | Term |
|---|---|
| D006547 | Hernia |
| ID | Term |
|---|---|
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| 17632147 | Result | 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. doi: 10.1016/j.juro.2007.05.028. Epub 2007 Jul 16. |
| 2815801 | Result | Pearl RK. Parastomal hernias. World J Surg. 1989 Sep-Oct;13(5):569-72. doi: 10.1007/BF01658872. |
| 18267165 | Result | Israelsson LA. Parastomal hernias. Surg Clin North Am. 2008 Feb;88(1):113-25, ix. doi: 10.1016/j.suc.2007.10.003. |
| 8678463 | Result | Martin L, Foster G. Parastomal hernia. Ann R Coll Surg Engl. 1996 Mar;78(2):81-4. |
| 16970577 | Result | 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. doi: 10.1111/j.1463-1318.2006.00996.x. |
| 2354601 | Result | Etherington RJ, Williams JG, Hayward MW, Hughes LE. Demonstration of para-ileostomy herniation using computed tomography. Clin Radiol. 1990 May;41(5):333-6. doi: 10.1016/s0009-9260(05)81696-4. |
| 11227945 | Result | Cheung MT, Chia NH, Chiu WY. Surgical treatment of parastomal hernia complicating sigmoid colostomies. Dis Colon Rectum. 2001 Feb;44(2):266-70. doi: 10.1007/BF02234303. |
| 19660211 | Result | 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. |
| 8154967 | Result | 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. doi: 10.1001/archsurg.1994.01420280091011. |
| 7489176 | Result | Stephenson BM, Phillips RK. Parastomal hernia: local resiting and mesh repair. Br J Surg. 1995 Oct;82(10):1395-6. doi: 10.1002/bjs.1800821033. No abstract available. |
| 18484151 | Result | 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. |
| 19300232 | Result | 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):583-7. doi: 10.1097/SLA.0b013e31819ec809. |
| 19011935 | Result | Janes 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. |
| 21929523 | Result | 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
Ethicon Physiomesh will be placed at the time of radical cystectomy and ileal conduit.
Ethicon Physiomesh: Ethicon Physiomesh will be paced at the time of radical cystectomy and ileal conduit.
|
| Secondary | Number of Participants Who Develop Mesh Related Complications | Assessed by physical examination including:
| The study required a minimum of 13 participants enrolled per arm for analysis of this outcome measure. Due to the manufacturer's (Ethicon) termination of the Physiomesh device, the study was prematurely terminated with fewer than minimum number of participants required on each arm, and the data were not analyzed. | Posted | 60 months |
|
|
| 0 |
| 6 |
| 0 |
| 6 |
| 0 |
| 6 |
| EG001 | Group 2 - Ileal Conduit With Mesh | Ethicon Physiomesh will be placed at the time of radical cystectomy and ileal conduit. Ethicon Physiomesh: Ethicon Physiomesh will be paced at the time of radical cystectomy and ileal conduit. | 0 | 6 | 0 | 6 | 0 | 6 |
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