Parastomal HerniaNCT02404545
Prevention of Parastomal Hernia by Mesh Placement
A study testing Ethicon Physiomesh in people with Parastomal Hernia, run by University of Miami at 1 site in United States.
Trial summary
Concurrent placement of a mesh during formation of ileal conduit will decrease the incidence of parastomal hernia and associated complications. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Parastomal Hernia
- What is being tested?
- Ethicon Physiomesh
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Aug 2015to Mar 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Patients unable or unwilling to consent to the proposed surgery
- Pregnant women
- Patients with prior ileal conduit surgery undergoing revision.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Study of the Utility of Composite Mesh Placement to Prevent Parastomal Hernia in Patients Undergoing Urinary Diversion With Ileal Conduit
Concurrent placement of a mesh during formation of ileal conduit will decrease the incidence of parastomal hernia and associated complications.
Read the detailed 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.
- Conditions
- Parastomal Hernia
- Being tested
- Ethicon Physiomesh
- Keywords
- Hernia, Mesh, Ileal conduit
- Medical subject headings
- Hernia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ethicon PhysiomeshDevice
Ethicon Physiomesh will be paced at the time of radical cystectomy and ileal conduit.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Ethicon Physiomesh |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 18 months
Secondary outcomes (1)
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.
Measured: 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2015 (estimated)
- Study start14 Aug 2015
- Primary completionAug 2016
- Study completionMar 2017
Why it stopped: Sponsor stopped producing device
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Parastomal HerniaStudies of the same condition, open and under way.
- More trials run by University of MiamiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- Ethicon, Inc.
- Responsible party
- Sponsor
- Investigators
- Murugesan Manoharan, MD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02404545
- Sponsor's protocol ID
- 20140277
- Status last verified
- Aug 2017
- First submitted
- 26 Mar 2015
- Last updated
- 25 Sep 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Carne PW, Robertson GM, Frizelle FA. Parastomal hernia. Br J Surg. 2003 Jul;90(7):784-93. doi: 10.1002/bjs.4220.
PubMed 12854101Israelsson LA. Preventing and treating parastomal hernia. World J Surg. 2005 Aug;29(8):1086-9. doi: 10.1007/s00268-005-7973-z.
PubMed 15981038Kouba 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.
PubMed 17632147Pearl RK. Parastomal hernias. World J Surg. 1989 Sep-Oct;13(5):569-72. doi: 10.1007/BF01658872.
PubMed 2815801Israelsson LA. Parastomal hernias. Surg Clin North Am. 2008 Feb;88(1):113-25, ix. doi: 10.1016/j.suc.2007.10.003.
PubMed 18267165Martin L, Foster G. Parastomal hernia. Ann R Coll Surg Engl. 1996 Mar;78(2):81-4.
PubMed 8678463Marimuthu 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.
PubMed 16970577Etherington 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.
PubMed 2354601Cheung 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.
PubMed 11227945Pastor 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.
PubMed 19660211Rubin 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.
PubMed 8154967Stephenson 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.
PubMed 7489176Hammond 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.
PubMed 18484151Serra-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.
PubMed 19300232Janes 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.
PubMed 19011935
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Study of the Utility of Composite Mesh Placement to Prevent Parastomal Hernia in Patients Undergoing Urinary Diversion With Ileal Conduit
- ClinicalTrials.gov ID
- NCT02404545
- Acronym / sponsor ID
- 20140277
- Conditions
- Parastomal Hernia
- Keywords
- Hernia, Mesh, Ileal conduit
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor stopped producing device
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- Ethicon, Inc.
- Study start
- 14 Aug 2015 (actual)
- Primary completion
- Aug 2016 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 31 Mar 2015 (estimated)
- Results
- Posted 25 Aug 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Concurrent placement of a mesh during formation of ileal conduit will decrease the incidence of parastomal hernia and associated complications.
Detailed 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Device: Ethicon PhysiomeshEthicon Physiomesh will be placed at the time of radical cystectomy and ileal conduit. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- Patients unable or unwilling to consent to the proposed surgery
- Pregnant women
- Patients with prior ileal conduit surgery undergoing revision.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ethicon PhysiomeshEthicon Physiomesh will be paced at the time of radical cystectomy and ileal conduit. | Device | Group 2 - Ileal Conduit with Mesh |
Primary outcome
Rate of Reduction of the Incidence of Parastomal Hernia
Time frame: 18 months
Rate of reduction of the incidence of parastomal hernia in study participants, as assessed by physical examination
1 secondary outcome
Number of Participants Who Develop Mesh Related Complications
Time frame: 60 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 12854101Carne PW, Robertson GM, Frizelle FA. Parastomal hernia. Br J Surg. 2003 Jul;90(7):784-93. doi: 10.1002/bjs.4220.
- Results publication: PubMed 15981038Israelsson LA. Preventing and treating parastomal hernia. World J Surg. 2005 Aug;29(8):1086-9. doi: 10.1007/s00268-005-7973-z.
- Results publication: PubMed 17632147Kouba 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.
- Results publication: PubMed 2815801Pearl RK. Parastomal hernias. World J Surg. 1989 Sep-Oct;13(5):569-72. doi: 10.1007/BF01658872.
- Results publication: PubMed 18267165Israelsson LA. Parastomal hernias. Surg Clin North Am. 2008 Feb;88(1):113-25, ix. doi: 10.1016/j.suc.2007.10.003.
- Results publication: PubMed 8678463Martin L, Foster G. Parastomal hernia. Ann R Coll Surg Engl. 1996 Mar;78(2):81-4.
- Results publication: PubMed 16970577Marimuthu 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.
- Results publication: PubMed 2354601Etherington 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.
- Results publication: PubMed 11227945Cheung 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.
- Results publication: PubMed 19660211Pastor 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.
- Results publication: PubMed 8154967Rubin 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.
- Results publication: PubMed 7489176Stephenson 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Murugesan Manoharan, MD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ethicon Physiomesh in people with Parastomal Hernia, run by University of Miami at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 25 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Aug 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Reduction of the Incidence of Parastomal Hernia (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02404545, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2017.