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

NCT00577603 | Completed DMC

• 1 other identifier: 1712-05
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Hernia

Keywords

stoma, hernia, mesh

Outcome Measures

Primary Outcomes (1)

• Rate of parastomal hernia formation.

  2 years post-op

Study Arms (2)

2

ACTIVE COMPARATOR

mesh reinforcement at stoma

Procedure: mesh reinforcement of stoma

Arm 1

ACTIVE COMPARATOR

standard stoma

Other: no intervention

Interventions

mesh reinforcement of stoma 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.

2

no intervention OTHER

Arm 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Phoenix, Arizona, 85054, United States

Location

MeSH Terms

Conditions

Hernia

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Kristi L Harold, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: General Surgery Clinical Study Coordinator

Study Record Dates

• First Submitted: December 18, 2007
• First Posted: December 20, 2007
• Study Start: January 1, 2006
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: April 25, 2013

Record last verified: 2013-04

Locations

US (1)