Clinical trial NCT00577603: Evaluate and Compare the Rate of Para-Stomal Herniation After Permanent Stoma Formation
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hernia
Keywords: stoma, hernia, mesh
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2007-12-20
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

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 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.

Primary outcomes:
measure: Rate of parastomal hernia formation.
timeFrame: 2 years post-op
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Mayo Clinic
state: Arizona
Study officials:
affiliation: Mayo Clinic
name: Kristi L Harold, MD
role: PRINCIPAL_INVESTIGATOR
References: