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

Hernia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00577603
• Other study ID #: 1712-05
• Status: Completed
• Phase: N/A
• First received: December 18, 2007
• Last updated: April 24, 2013
• Start date: January 2006
• Est. completion date: June 2011

Study information

• Verified date: April 2013
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hernia

Intervention

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

Locations

Country	Name	City	State
United States	Mayo Clinic	Phoenix	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of parastomal hernia formation.		2 years post-op	No