Prospective Trial Comparing Two Different Polypropylene Meshes for Inguinal Hernias

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified October 2013 by South East Area Health Education Center, Wilmington, NC
Sponsor:
Collaborator:
New Hanover Regional Medical Center
Information provided by (Responsible Party):
William Hope, South East Area Health Education Center, Wilmington, NC
ClinicalTrials.gov Identifier:
NCT01825187
First received: March 8, 2013
Last updated: October 26, 2013
Last verified: October 2013
  Purpose

The purpose of this research study is to measure the clinical effectiveness of two different polypropylene meshes used for laparoscopic inguinal hernias by evaluating subjects' length of hospital stay, perioperative complications, recurrence rate, pain score, comfort level and postoperative quality of life. A secondary goal of the study is to evaluate the ease of use and time it takes surgical residents to place the mesh and perform the surgery using these two different meshes.


Condition Intervention
Hernia, Inguinal
Device: ULTRAPRO Mesh
Device: 3DMAX
Other: Evaluation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prospective Randomized Controlled Trial Comparing Resident Performance and Clinical Outcomes With Two Different Polypropylene Meshes for Laparoscopic Inguinal Hernias

Resource links provided by NLM:


Further study details as provided by South East Area Health Education Center, Wilmington, NC:

Primary Outcome Measures:
  • To evaluate the clinical effectiveness of two currently used meshes for inguinal hernias [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    The primary purpose of this research study is to evaluate the clinical effectiveness and/or to provide evidence of whether or not one polypropylene mesh is more effective than the other. This will be done by measuring whether or not a "lighter weight" form of a polypropylene mesh may improve a patient's quality of life outcomes following laparoscopic inguinal hernia surgery.


Secondary Outcome Measures:
  • To evaluate the ease of use and time it takes surgical residents to place the mesh and perform the surgery using these two different meshes. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    This information may make it possible to determine if one mesh is easier for residents to use during surgery and therefore take them less time to perform the surgical procedure. This information may aid in lessening the amount of time the patient spends in the operating room thus lowering medical costs as well as improving patient outcomes.


Estimated Enrollment: 511
Study Start Date: April 2014
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Treatment Group 1
Patients in this group will be randomized to receive the ULTRAPRO mesh
Device: ULTRAPRO Mesh
Patients who are randomized to this group will received ULTRAPRO Mesh for their hernia repair
Active Comparator: Treatment Group 2
Patients in this group will be randomized to receive the 3DMAX Mesh
Device: 3DMAX
Patients who are randomized to this group will receive 3DMAX mesh for their hernia repair
Evaluation of Surgical Residents
Surgical residents will be evaluated on the ease of use and the amount of time it takes for them to perform the surgery using these two different meshes.
Other: Evaluation
To evaluate the ease of use and time it takes residents to place and perform the surgery using these two different meshes.

Detailed Description:

Inguinal hernia repair is one of the most common operations performed by general surgeons in the world. There are two main ways to repair an inguinal hernia, open or laparoscopic. Open compared to laparoscopic, is more invasive and leads to more scarring and longer recovery periods. Laparoscopic repair is done by making a small cut in or just below the umbilicus and has become an accepted standard for inguinal hernia repair and has become the technique of choice for recurrent inguinal hernias.

During laparoscopic repair, the placement of a prosthetic mesh aids in reinforcing the abdominal wall and allowing for tension free repair. Meshes also helps to lower the recurrence rate. The most safe and effective type of mesh prosthesis currently being used in laparoscopic inguinal hernia repairs are polypropylene meshes. There is some emerging evidence that "lighter weight" forms of polypropylene meshes may improve quality of life outcomes following surgery for inguinal hernias. Further evaluation is needed to support this evidence.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects undergoing laparoscopic repair for the treatment of either single or bilateral inguinal hernias
  • All surgical residents at New Hanover Regional Medical Center

Exclusion Criteria:

  • Subjects requiring emergency surgery
  • Pregnant subjects
  • Subjects under the age of 18 years of age
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01825187

Contacts
Contact: Chiquta Harris, BS 910.667.9253 Chiquta.Harris@seahec.net

Sponsors and Collaborators
South East Area Health Education Center, Wilmington, NC
New Hanover Regional Medical Center
Investigators
Principal Investigator: William W Hope, MD South East Area Health Education Center
  More Information

No publications provided

Responsible Party: William Hope, Director of Surgical Education/Assistant Professor of Surgery, South East Area Health Education Center, Wilmington, NC
ClinicalTrials.gov Identifier: NCT01825187     History of Changes
Other Study ID Numbers: 1302-1
Study First Received: March 8, 2013
Last Updated: October 26, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Hernia
Hernia, Inguinal
Hernia, Abdominal
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on October 20, 2014