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Evaluate and Compare the Rate of Para-Stomal Herniation After Permanent Stoma Formation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Laurie Mihalik, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00577603
First received: December 18, 2007
Last updated: April 24, 2013
Last verified: April 2013
History of Changes
  Purpose
This study is being done to evaluate the use of a material (Alloderm collagen mesh) during the stomal formation operation (surgery that will create a mouth-like opening on the surface of the body to an internal organ). The main purpose of this research study is to see if using this material will lower the hernia rate compared to normal repair without this material. The secondary purpose is to evaluate if using this material will increase or decrease complication rates.

Condition Intervention
Hernia
 Procedure: mesh reinforcement of stoma
Other: no intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Hernia
U.S. FDA Resources

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Rate of parastomal hernia formation. [ Time Frame: 2 years post-op ] [ Designated as safety issue: No ]
Enrollment: 40
Study Start Date: January 2006
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 2
mesh reinforcement at stoma
 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
 Other: no intervention

Detailed Description:
This study seeks to examine the ability of an implantable collagen matrix to reduce the incidence of parastomal hernia formation. Patients will be randomized preoperatively by a computer generated random allocation to either receive collagen mesh at the time of stoma formation, or to have stoma formation without mesh. Stomas without mesh will be made in the standard surgical fashion dictated by the type of stoma: ileostomy, colostomy, ileal conduit. Patients randomized to receive mesh will undergo stoma formation in an identical fashion, and will have a 8 cm x 12cm piece of AlloDerm mesh placed as a tissue reinforcement at the stoma site and extending under the midline incision. Patients will be followed with physical examinations at approximately 2weeks post-op, 3, 6, 9, 12, 24 months post-op, and will undergo CT scanning of the abdomen and pelvis at 12 and 24months to determine hernia occurrence.
  Eligibility
Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Patients will be at least 18 years of age.
  2. Male or female (excluding pregnant females).
  3. Patients will require stoma formation.
  4. Patients with ASA < 3.
  5. Patients informed about the study, and will have read; understood and signed the patient informed consent and authorization to use their PHI, as applicable.
  6. Patients will be willing and able to submit to postoperative follow-up evaluations.

Exclusion Criteria:

  1. Patients that have had prior surgical treatment parastomal herniation.
  2. Patients that refuse stoma formation.
  3. Patients with ASA > 3.
  4. Patients who have certain metabolic conditions (e.g., chronic hepatic or renal disease).
  5. Patients with evidence of pre-existing systemic or local infections.
  6. Patients with wound-healing or autoimmune disorders.
  7. Patients who, in the surgeon's opinion, would have a difficult time comprehending or complying with the requirements of the study.
  8. Patients with any conditions that were not suspected preoperatively and are only discovered at the time of the operation.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00577603

Locations
United States, Arizona
Mayo Clinic
Phoenix, Arizona, United States, 85054
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Kristi L Harold, MD Mayo Clinic
  More Information

Responsible Party: Laurie Mihalik, General Surgery Clinical Study Coordinator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT00577603     History of Changes
Other Study ID Numbers: 1712-05 
Study First Received: December 18, 2007
Last Updated: April 24, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
stoma, hernia, mesh

Additional relevant MeSH terms:
Hernia
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on September 23, 2016