Mesh vs Pledgets for Hernia Repair

Recruiting in Palo Alto (17 mi)

Overseen by Michael J Rosen, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Michael Rosen

Disqualifiers: Pregnancy, BMI >45, Allergy, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial is to compare whether the use of Ovitex mesh provides superior reduction in 2-year recurrence compared to pledgeted suture closure (no mesh) for patients undergoing paraesophageal hernia repair at the Cleveland Clinic. The main questions it aims to answer are: * Determine whether there is a difference in 2-year rates of radiographic recurrence with Ovitex versus pledgeted sutures in paraesophageal hernia repair. * Assess patient quality of life (QOL) after paraesophageal hernia repair with pledgets and mesh. A two-tailed research hypothesis will be used to determine whether there are differences between the two arms

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of this treatment for hernia repair?

Research shows that OviTex, a reinforced tissue matrix used in hernia repair, is effective in reducing the body's inflammatory response, promoting healing, and providing strong support to prevent hernia recurrence. ^{1 2 3 4 5}

Is the use of mesh or pledgets for hernia repair generally safe in humans?

Research on mesh used in other surgeries, like for stress urinary incontinence and pelvic organ prolapse, shows that there can be complications, but these are often related to how the mesh is anchored rather than the mesh itself. Long-term studies suggest that using mesh without anchoring can minimize complications. ^{6 7 8 9 10}

How is the treatment using OviTex Mesh and Pledgeted sutures for hernia repair different from other treatments?

The OviTex Mesh used in hernia repair is unique because it combines a biologic scaffold with minimal polymer reinforcement, which helps reduce inflammation and supports the abdominal wall more effectively. This hybrid approach promotes healing and reduces the risk of hernia recurrence by encouraging tissue regeneration and minimizing the foreign body response typically seen with traditional polymer meshes. ^{1 2 3 11 12}

Eligibility Criteria

This trial is for adults who can consent and participate in long-term follow-up, with a Type II, III, or IV hiatal hernia larger than 5 cm. It's not for individuals with a BMI over 45, those who've had previous hernia repairs, are pregnant, allergic to mesh materials or undergoing stomach volume reduction procedures.

Inclusion Criteria

I am willing and able to attend all study visits and complete surveys.

I have a large hiatal hernia confirmed by imaging or surgery.

I am 18 years old or older.

Exclusion Criteria

Allergy to any components of mesh

BMI >45

Pregnancy

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo paraesophageal hernia repair with either Ovitex mesh or pledgeted sutures

Hospital stay until discharge

In-hospital stay

Follow-up

Participants are monitored for safety, effectiveness, and quality of life post-surgery

2 years

1-month visit, annual visits through 2 years

Long-term follow-up

Participants are monitored for long-term outcomes and recurrence

Additional 3 years

Treatment Details

Interventions

• OviTex Mesh (Procedure)
• Pledgeted sutures (Procedure)

Trial Overview The study compares Ovitex mesh use against pledgeted sutures in paraesophageal hernia repair regarding their effect on the recurrence rate after two years and patient quality of life post-surgery at Cleveland Clinic.

Participant Groups

Group I: Pledgeted suture-based crural reinforcement Experimental Treatment 1 Intervention

Patient will receive pledgeted sutures to reinforce the crural repair

Group II: Mesh-based crural reinforcement Experimental Treatment 1 Intervention

Patient will receive Ovitex mesh to reinforce the crural repair

OviTex Mesh is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as OviTex for:

• Hernia repair
• Abdominal wall reconstruction
• Paraesophageal hernia repair
• Hiatal hernia repair

🇪🇺 Approved in European Union as OviTex for:

• Hernia repair
• Abdominal wall reconstruction
• Paraesophageal hernia repair
• Hiatal hernia repair

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Cleveland Clinic Center for Abdominal Core Health Cleveland, OH

Who Is Running the Clinical Trial?

Michael Rosen Lead Sponsor

The Cleveland Clinic Lead Sponsor

References

1. England pubmed.ncbi.nlm.nih.gov

Contamination of hybrid hernia meshes compared to bioresorbable Phasix™ Mesh in a rabbit subcutaneous implant inoculation model. [2022] Hybrid hernia meshes combine biological tissue-derived extracellular matrix with permanent or resorbable synthetic. The objective of this study was to evaluate hybrid meshes (Gore® Synecor, Zenapro™, Ovitex™ 1S Reinforced Bioscaffold Permanent, and Ovitex™ 1S Reinforced Bioscaffold Resorbable) compared to non-hybrid, bioresorbable synthetic mesh (Phasix™ Mesh) in a rabbit bacterial inoculation model.

2. Switzerland pubmed.ncbi.nlm.nih.gov

A Prospective, Single Arm, Multi-Center Study Evaluating the Clinical Outcomes of Ventral Hernias Treated with OviTex® 1S Permanent Reinforced Tissue Matrix: The BRAVO Study 12-Month Analysis. [2021] Conflicting results from previous studies have led to dissent over whether surgical mesh is safe and effective in ventral hernia repair. A newer class of mesh known as a reinforced tissue matrix, combining a biologic scaffold and minimal polymer reinforcement, offers promise in reducing inflammatory response and increasing abdominal wall support. This study sought to assess the clinical utility of a reinforced tissue matrix (OviTex) in ventral hernia repair 12 months after implantation.

3. Switzerland pubmed.ncbi.nlm.nih.gov

A Polymer-Biologic Hybrid Hernia Construct: Review of Data and Early Experiences. [2021] Surgical mesh reinforcement of the human abdominal wall has been found to reduce the chance of recurrence in hernia repairs. While traditionally polymer meshes have been used in hernia repair, alternative mesh options have been engineered to prevent the inflammatory foreign body response invoked by polymers. A reinforced tissue matrix (RTM) mesh has been developed by embedding a polymer within a decellularized extracellular matrix. This combination has been attributed to the recruitment of host cells, a pro-healing response, and attenuation of the foreign body response. This has been observed to lead to the regeneration of functional tissue within the repair site that is reinforced by the polymer to offload abdominal pressures over time. This manuscript presents the review of OviTex, an RTM, in several types of hernia repair. The authors have found that the use of RTM in hernia repair is effective in preventing foreign body response, promoting wound healing, and providing reinforcement to lower the risk of hernia recurrence.

4. Canada pubmed.ncbi.nlm.nih.gov

An in-house Composix™-based pubovaginal sling trial for female stress urinary incontinence: Five-year comparative followup to tension-free and transobturator vaginal tapes. [2020] We compared the efficacy of three slings in the long-term treatment of stress urinary incontinence (SUI): tension-free vaginal tape (TVT), vaginal tape-obturator (TVT-O), and an in-house two-layered polypropylene mesh with a submicronic polytetrafluoroethylene (Composix™). Our primary endpoint was the objective measurement of continence (24-hour pad test). Secondarily, we measured the satisfaction and complication rates.

5. Switzerland pubmed.ncbi.nlm.nih.gov

Prevention of adhesion to prosthetic mesh in incisional ventral hernias: comparison of different barriers in an experimental model. [2016] The purpose of this study was to compare the intra-abdominal adhesion formation following ventral hernia repair by using oxidized regenerated cellulose (ORC) as a barrier underneath polypropylene mesh (PPM), and sodium hyaluronate/carboxymethylcellulose (HA/CMC)-coated PPM.

6. Italy pubmed.ncbi.nlm.nih.gov

Single-incision needleless mini-sling technique for female stress urinary incontinence: A comparative study with standard transobturator inside-out technique. [2023] To evaluate the safety and efficacy of surgeon-tailored polypropylene mesh (STM) through a needle-less single incision mini-slings (SIMS) vs. standard trans-obturator tape (TOT) in the treatment of female stress urinary incontinence (SUI).

7. England pubmed.ncbi.nlm.nih.gov

Surgical treatment of advanced anterior wall and apical vaginal prolapse using the anchorless self-retaining support implant: long-term follow-up. [2022] Following health notification by the FDA in 2008 of serious complications with transvaginal mesh for anterior pelvic organ prolapse, there has been a return to native tissue repairs. Earlier work with a self-retaining support (SRS) implant showed a high anatomical success rate with minimal implant-related complications over a medium-term follow-up. It is proposed that post-implant complications are more a consequence of the method of mesh anchoring rather than the implant itself. Our system incorporates an ultralight mesh with a frame that provides level I, II, and III support without the need for fixation. The first long-term outcomes of SRS implantation are presented.

8. United States pubmed.ncbi.nlm.nih.gov

TVT-Secur (Hammock) versus TVT-Obturator: a randomized trial of suburethral sling operative procedures. [2021] This study aimed to compare TVT-Secur (TVT-S) and TVT-Obturator (TVT-O) suburethral slings for treatment of stress urinary incontinence (SUI).

9. England pubmed.ncbi.nlm.nih.gov

Adverse events after first, single, mesh and non-mesh surgical procedures for stress urinary incontinence and pelvic organ prolapse in Scotland, 1997-2016: a population-based cohort study. [2022] Concerns have been raised about the safety of surgery for stress urinary incontinence and pelvic organ prolapse using transvaginal mesh. We assessed adverse outcomes after first, single mesh procedures and comparable non-mesh procedures.

10. Switzerland pubmed.ncbi.nlm.nih.gov

Objective and subjective cure rates after trans-obturator tape (OBTAPE) treatment of female urinary incontinence. [2006] To evaluate the safety and efficacy of a thermally bonded nonwoven polypropylene mesh in a transobturator suburethral tape procedure (OBTAPE), Mentor-Porges, Le Plessis Robinson, France) for women with stress urinary incontinence.

11. United States pubmed.ncbi.nlm.nih.gov

Ventralight ST and SorbaFix versus Physiomesh and Securestrap in a porcine model. [2021] The objective of this study was to compare mesh contracture, adhesion characteristics, tissue ingrowth, and histologic response of Ventralight ST/SorbaFix (C.R. Bard/Davol, Warwick, RI, USA) with Physiomesh/Securestrap (Ethicon, Somerville, NJ, USA) in a porcine model of laparoscopic ventral hernia repair.

12. Denmark pubmed.ncbi.nlm.nih.gov

[Adhesion after laparoscopic ventral hernia repair]. [2008] Four patients treated laparoscopically for ventral hernia (LVH) using W3 mesh (Cousin Biotech, France) and Protack (Tyco Healthcare, USA) were reoperated laparoscopically after 5, 6, 14 and 23 months for recurrent hernia (two cases) and a new hernia proximal to the primary mesh (two cases). In all patients we found adhesions toward the mesh and fixation devices that increased in severity and extent with time, rendering dissection difficult and dangerous. These findings cause concern and suggest that current validation methods for materials used in LVH should be re-evaluated.