Prospective Trial Comparing Two Different Polypropylene Meshes for Inguinal Hernias

NCT01825187 | Completed Results

• 1 other identifier: 1302-1
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hernia, Inguinal

Outcome Measures

Primary Outcomes (1)

• Inguinal Hernia Mesh Insertion Times

  The primary outcome measure was a comparison of mesh insertion times and were tested using a 2 × 2 ANOVA on the ranked times. Timing of the mesh placement was documented, which included time from mesh insertion in the trocar until completion of mesh fixation. Laparoscopic fixation was performed by placing four tacks; two in the pubic bone, one medial, and one lateral on the upper portion of the mesh. The types of tacks used were AbsorbaTack™ (Medtronics), sutures, CapSure™ (CR Bard) and OptiFix™ (CR Bard). Timing of mesh placement in robotic repairs included mesh placement and the time to place three suture fixation points; one at the pubis, one at the anterior, and 1 at the lateral abdominal wall at the top of the mesh.

  During the procedure an average of an hour

Secondary Outcomes (1)

• NASA TLX Survey Index Scores

  During procedure an average of 1 hour

Study Arms (3)

Treatment Group 1

ACTIVE COMPARATOR

Patients in this group will be randomized to receive the ULTRAPRO mesh

Device: ULTRAPRO Mesh

Treatment Group 2

ACTIVE COMPARATOR

Patients in this group will be randomized to receive the 3DMAX Mesh

Device: 3DMAX

Evaluation of Surgical Residents

OTHER

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

Interventions

ULTRAPRO Mesh DEVICE

Patients who are randomized to this group will received ULTRAPRO Mesh for their hernia repair

Treatment Group 1

3DMAX DEVICE

Patients who are randomized to this group will receive 3DMAX mesh for their hernia repair

Treatment Group 2

Evaluation OTHER

To evaluate the ease of use and time it takes residents to place and perform the surgery using these two different meshes.

Evaluation of Surgical Residents

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• Subjects requiring emergency surgery
• Pregnant subjects
• Subjects under the age of 18 years of age

Sponsors & Collaborators

• South East Area Health Education Center, Wilmington, NC: lead
• New Hanover Regional Medical Center: collaborator

Study Sites (1)

New Hanover Regional Medical Center

Wilmington, North Carolina, 28401, United States

Location

Related Publications (1)

• Bilezikian JA, Tenzel PL, Johnson RG, Powers WF 4th, Hope WW. A preliminary evaluation of two different meshes in minimally invasive inguinal hernia surgery. Surg Endosc. 2021 Mar;35(3):1342-1347. doi: 10.1007/s00464-020-07512-9. Epub 2020 Mar 30.

  PMID: 32232645 DERIVED

MeSH Terms

Conditions

Hernia, Inguinal

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. William Hope
• Organization: New Hanover Regional medical Center

william.hope@nhrmc.org

(910)667-9233

Study Officials

• William W Hope, MD

  South East Area Health Education Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Surgical Education/Assistant Professor of Surgery

Study Record Dates

• First Submitted: March 8, 2013
• First Posted: April 5, 2013
• Study Start: June 1, 2014
• Primary Completion: August 31, 2020
• Study Completion: August 31, 2020
• Last Updated: June 14, 2022
• Results First Posted: June 14, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)