Evaluate and Compare the Rate of Para-Stomal Herniation After Permanent Stoma Formation
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ClinicalTrials.gov Identifier: NCT00577603 |
Recruitment Status :
Completed
First Posted : December 20, 2007
Last Update Posted : April 25, 2013
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hernia | Procedure: mesh reinforcement of stoma Other: no intervention | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 40 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
Official Title: | A Controlled, Randomized Study to Evaluate and Compare the Rate of Para-Stomal Herniation After Permanent Stoma Formation With and Without Reinforcement With a Collagen Mesh |
Study Start Date : | January 2006 |
Actual Primary Completion Date : | June 2011 |
Actual Study Completion Date : | June 2011 |
Arm | Intervention/treatment |
---|---|
Active Comparator: 2
mesh reinforcement at stoma
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Procedure: mesh reinforcement of stoma
Patients randomized to receive mesh will undergo stoma formation and will have a 8 cm x 12 cm piece of AlloDerm graft placed as a tissue reinforcement around the stoma and extending under the midline incision. The mesh will be trimmed to provide a minimum of 3cm of overlap around the stoma in all directions. The mesh will be secured with transabdominal number one Prolene (Ethicon, Inc) sutures every 4cm around the mesh. Additional fixation will be provided with Protack spiral tacks (US Surgical, Inc) every 1cm around the mesh. The midline fascia will be closed with running number one Prolene sutures. Skin will be closed in standard fashion. |
Active Comparator: Arm 1
standard stoma
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Other: no intervention |
- Rate of parastomal hernia formation. [ Time Frame: 2 years post-op ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Patients will be at least 18 years of age.
- Male or female (excluding pregnant females).
- Patients will require stoma formation.
- Patients with ASA < 3.
- Patients informed about the study, and will have read; understood and signed the patient informed consent and authorization to use their PHI, as applicable.
- Patients will be willing and able to submit to postoperative follow-up evaluations.
Exclusion Criteria:
- Patients that have had prior surgical treatment parastomal herniation.
- Patients that refuse stoma formation.
- Patients with ASA > 3.
- Patients who have certain metabolic conditions (e.g., chronic hepatic or renal disease).
- Patients with evidence of pre-existing systemic or local infections.
- Patients with wound-healing or autoimmune disorders.
- Patients who, in the surgeon's opinion, would have a difficult time comprehending or complying with the requirements of the study.
- Patients with any conditions that were not suspected preoperatively and are only discovered at the time of the operation.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00577603
United States, Arizona | |
Mayo Clinic | |
Phoenix, Arizona, United States, 85054 |
Principal Investigator: | Kristi L Harold, MD | Mayo Clinic |
Responsible Party: | Laurie Mihalik, General Surgery Clinical Study Coordinator, Mayo Clinic |
ClinicalTrials.gov Identifier: | NCT00577603 |
Other Study ID Numbers: |
1712-05 |
First Posted: | December 20, 2007 Key Record Dates |
Last Update Posted: | April 25, 2013 |
Last Verified: | April 2013 |
stoma, hernia, mesh |
Hernia Pathological Conditions, Anatomical |