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

Primary Purpose

Hernia

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

mesh reinforcement of stoma

no intervention

About this trial

This is an interventional prevention trial for Hernia focused on measuring stoma, hernia, mesh

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Mayo Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Arm 1

Arm Description

mesh reinforcement at stoma

standard stoma

Outcomes

Primary Outcome Measures

Rate of parastomal hernia formation.

Secondary Outcome Measures

Full Information

NCT ID

NCT00577603

First Posted

December 18, 2007

Last Updated

April 24, 2013

Sponsor

Mayo Clinic

1. Study Identification

Unique Protocol Identification Number

NCT00577603

Brief Title

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

2. Study Status

Record Verification Date

April 2013

Overall Recruitment Status

Completed

Study Start Date

January 2006 (undefined)

Primary Completion Date

June 2011 (Actual)

Study Completion Date

June 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Mayo Clinic

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hernia

Keywords

stoma, hernia, mesh

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Description

mesh reinforcement at stoma

Arm Title

Arm 1

Arm Type

Active Comparator

Arm Description

standard stoma

Intervention Type

Procedure

Intervention Name(s)

mesh reinforcement of stoma

Intervention Description

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

Other

Intervention Name(s)

no intervention

Primary Outcome Measure Information:

Title

Rate of parastomal hernia formation.

Time Frame

2 years post-op

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kristi L Harold, MD

Organizational Affiliation

Mayo Clinic

Official's Role

Principal Investigator

Facility Information:

Facility Name

Mayo Clinic

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85054

Country

United States

12. IPD Sharing Statement

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

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