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

December 18, 2007
April 24, 2013
January 2006
June 2011   (final data collection date for primary outcome measure)
Rate of parastomal hernia formation. [ Time Frame: 2 years post-op ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00577603 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Evaluate and Compare the Rate of Para-Stomal Herniation After Permanent Stoma Formation
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

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Hernia
  • 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.
  • Other: no intervention
  • Active Comparator: 2
    mesh reinforcement at stoma
    Intervention: Procedure: mesh reinforcement of stoma
  • Active Comparator: Arm 1
    standard stoma
    Intervention: Other: no intervention
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
June 2011
June 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00577603
1712-05
Yes
Laurie Mihalik, Mayo Clinic
Mayo Clinic
Not Provided
Principal Investigator: Kristi L Harold, MD Mayo Clinic
Mayo Clinic
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP