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

NCT ID: NCT00577603

Last Updated: 2013-04-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-01-31
• Study Completion Date: 2011-06-30

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.

Conditions

Hernia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

2

mesh reinforcement at stoma

Group Type: ACTIVE_COMPARATOR

mesh reinforcement of stoma

Intervention Type: PROCEDURE

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.

Arm 1

standard stoma

Group Type: ACTIVE_COMPARATOR

no intervention

Intervention Type: OTHER

Interventions

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.

Intervention Type: PROCEDURE

no intervention

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Laurie Mihalik

General Surgery Clinical Study Coordinator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kristi L Harold, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic

Phoenix, Arizona, United States

Countries

United States

Other Identifiers

1712-05

Identifier Type: -

Identifier Source: org_study_id