NCT02404545

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2015

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 26, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 31, 2015

Completed
5 months until next milestone

Study Start

First participant enrolled

August 14, 2015

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
6 months until next milestone

Results Posted

Study results publicly available

August 25, 2017

Completed
Last Updated

September 25, 2017

Status Verified

August 1, 2017

Enrollment Period

12 months

First QC Date

March 26, 2015

Results QC Date

July 25, 2017

Last Update Submit

August 24, 2017

Conditions

Parastomal Hernia

Keywords

HerniaMeshIleal conduit

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Number of Participants Who Develop Mesh Related Complications

    60 months

Study Arms (2)

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.

Device: Ethicon Physiomesh

Interventions

Ethicon PhysiomeshDEVICE

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

Group 2 - Ileal Conduit with Mesh

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients eligible to undergo urinary diversion with ileal conduit.
  • Patients with the ability to understand and willingness to sign a written informed consent document.
  • Men and Women aged 18 to 80 years.

You may not qualify if:

  • Patients unable or unwilling to consent to the proposed surgery
  • Pregnant women
  • Patients with prior ileal conduit surgery undergoing revision.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Of Miami

Miami, Florida, 33136, United States

Location

Related Publications (16)

  • Carne PW, Robertson GM, Frizelle FA. Parastomal hernia. Br J Surg. 2003 Jul;90(7):784-93. doi: 10.1002/bjs.4220.

    PMID: 12854101RESULT

  • Israelsson LA. Preventing and treating parastomal hernia. World J Surg. 2005 Aug;29(8):1086-9. doi: 10.1007/s00268-005-7973-z.

    PMID: 15981038RESULT

  • 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.

    PMID: 17632147RESULT

  • Pearl RK. Parastomal hernias. World J Surg. 1989 Sep-Oct;13(5):569-72. doi: 10.1007/BF01658872.

    PMID: 2815801RESULT

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

    PMID: 18267165RESULT

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

    PMID: 8678463RESULT

  • 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.

    PMID: 16970577RESULT

  • 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.

    PMID: 2354601RESULT

  • 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.

    PMID: 11227945RESULT

  • 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.

    PMID: 19660211RESULT

  • 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.

    PMID: 8154967RESULT

  • 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.

    PMID: 7489176RESULT

  • 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.

    PMID: 18484151RESULT

  • 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.

    PMID: 19300232RESULT

  • 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.

    PMID: 19011935RESULT

  • 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.

    PMID: 21929523RESULT

MeSH Terms

Conditions

Hernia

Condition Hierarchy (Ancestors)

Pathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Limitations and Caveats

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.

Results Point of Contact

Title
Murugesan Manoharan MD, FRCS (Eng), FRACS (Urol)
Organization
Baptist Health South Florida - Miami Cancer Institute
mmanoharan@baptisthealth.net
305-595-2141

Study Officials

  • Murugesan Manoharan, MD

    University of Miami

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 26, 2015

First Posted

March 31, 2015

Study Start

August 14, 2015

Primary Completion

August 1, 2016

Study Completion

March 1, 2017

Last Updated

September 25, 2017

Results First Posted

August 25, 2017

Record last verified: 2017-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)