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

Sponsored by:	Mayo Clinic
Information provided by:	Mayo Clinic
ClinicalTrials.gov Identifier:	NCT00577603

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) that you have been scheduled for. 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

MedlinePlus related topics: Hernia

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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

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 ]

Estimated Enrollment:	40
Study Start Date:	January 2006
Estimated Study Completion Date:	January 2010

Arms	Assigned Interventions
1: No Intervention standard 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 re-inforcement 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.
2: Active Comparator 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 re-inforcement 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.

Arms

Assigned Interventions

1: No Intervention

standard 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 re-inforcement 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.

2: Active Comparator

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 re-inforcement 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.

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 re-inforcement 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
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Patients that have had prior surgical treatment parastomal herniation.
Patients that refuse stoma formation.
Patients with ASA > 3.
Patients who have certain metabolic conditions (e.g., chronic hepatic or renal disease).
Patients with evidence of pre-existing systemic or local infections.
Patients with wound-healing or autoimmune disorders.
Patients who, in the surgeon's opinion, would have a difficult time comprehending or complying with the requirements of the study.
Patients with any conditions that were not suspected preoperatively and are only discovered at the time of the operation.

Contacts and Locations

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

Contacts

Contact: Kristi L Harold, MD	480-342-2000	harold.kristi@mayo.edu
Contact: Debra Ryan	480-301-8376

Locations

United States, Arizona
Mayo Clinic	Recruiting
Phoenix, Arizona, United States, 85054
Principal Investigator: Kristi l Harold, MD

Sponsors and Collaborators

Mayo Clinic

Investigators

Principal Investigator:

Kristi L Harold, MD

Mayo Clinic

More Information

Responsible Party:	Mayo Clinic ( Kristi L. Harold, MD )
Study ID Numbers:	1712-05
Study First Received:	December 18, 2007
Last Updated:	December 19, 2007
ClinicalTrials.gov Identifier:	NCT00577603
Health Authority:	United States: Institutional Review Board

Keywords provided by Mayo Clinic:

stoma, hernia, mesh

Study placed in the following topic categories:

Pathological Conditions, Anatomical
Hernia

ClinicalTrials.gov processed this record on January 16, 2009