Heavy Weight Versus Medium Weight Mesh in Ventral Hernia Repair

NCT03082391 | Completed Results FDA Device

• 1 other identifier: 16-1643
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine if mesh weight has an impact on postoperative pain, ventral hernia recurrence, incidence of deep wound infection, and overall quality of life following ventral hernia repair with mesh.

Conditions

Ventral Hernia

Keywords

Ventral Hernia Repair; Heavy weight Mesh; Medium weight Mesh

Outcome Measures

Primary Outcomes (1)

• Pain Scores

  Pain Scores will be measured using the NIH Promis 3A Pain Scale. PROMIS® Pain Intensity 3A is a three-question instrument developed to measure the range of pain experienced in the week prior to assessment. The raw score (3-15) is converted into a T-score where 50 (SD 10) represents the average of people with at least mild pain, higher numbers (maximum 71.8) represent higher than average pain, and the lowest score (30.7) represents no pain.

  One Year Postoperatively

Secondary Outcomes (3)

• Number of Subjects With Hernia Recurrence

  One Year Postoperatively

• Deep Wound Infection

  30-Days Postoperatively

• Quality of Life Scores

  One Year Postoperatively

Study Arms (2)

Heavy weight Mesh

ACTIVE COMPARATOR

Intervention: Patients will undergo ventral hernia repair with implantation of a heavy weight mesh.

Device: Heavy weight Mesh

Medium weight Mesh

ACTIVE COMPARATOR

Intervention: Patients will undergo ventral hernia repair with implantation of a medium weight mesh.

Device: Heavy weight Mesh; Device: Medium weight Mesh

Interventions

Heavy weight Mesh DEVICE

Patients will undergo ventral hernia repair with heavy weight mesh.

Heavy weight Mesh; Medium weight Mesh

Medium weight Mesh DEVICE

Patients will undergo ventral hernia repair with medium weight mesh.

Medium weight Mesh

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older
• Will undergo a single-stage, open, retromuscular ventral hernia repair
• CDC Wound Class 1
• Able to achieve midline fascial closure
• Hernia defect width less than or equal to 20 centimeters (measured intraoperatively)
• Able to tolerate general anesthesia
• Able to give informed consent

You may not qualify if:

• Patients who are less than 18 years of age
• Patients who undergo emergent ventral hernia repair
• Patients who undergo laparoscopic or robotic ventral hernia repair
• Patients with CDC Wound Class 2, 3, or 4
• Patients who are unable to undergo successful retromuscular mesh placement or who cannot achieve midline fascial closure
• Patients who undergo staged repair of their ventral hernia
• Patients who are unable to give informed consent
• Patients who cannot tolerate general anesthesia
• Patients who are pregnant at the time of surgical intervention

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Related Publications (1)

• Krpata DM, Petro CC, Prabhu AS, Tastaldi L, Zolin S, Fafaj A, Rosenblatt S, Poulose BK, Pierce RA, Warren JA, Carbonell AM, Goldblatt MI, Stewart TG, Olson MA, Rosen MJ. Effect of Hernia Mesh Weights on Postoperative Patient-Related and Clinical Outcomes After Open Ventral Hernia Repair: A Randomized Clinical Trial. JAMA Surg. 2021 Dec 1;156(12):1085-1092. doi: 10.1001/jamasurg.2021.4309.

  PMID: 34524395 DERIVED

MeSH Terms

Conditions

Hernia, Ventral

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. Michael Rosen
• Organization: Cleveland Clinic Foundation

rosenm@ccf.org

2164453441

Study Officials

• Michael J Rosen, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Comprehensive Hernia Center

Study Record Dates

• First Submitted: March 12, 2017
• First Posted: March 17, 2017
• Study Start: March 14, 2017
• Primary Completion: May 28, 2020
• Study Completion: May 28, 2020
• Last Updated: July 14, 2022
• Results First Posted: June 22, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)