Mesh vs Pledgets for Hernia Repair

Overseen By Ryan C Ellis, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Michael Rosen

Disqualifiers: Pregnancy, BMI >45, Allergy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: Hospital stay until discharge

164 Participants Needed

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}

Research Team

Michael J Rosen, MD

Principal Investigator

The Cleveland Clinic

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

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
• Pledgeted sutures

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

Who Is Running the Clinical Trial?

Michael Rosen

Lead Sponsor

Trials

3

Recruited

520+

The Cleveland Clinic

Lead Sponsor

Trials

1,072

Recruited

1,377,000+

Findings from Research

In a study involving 25 rabbits, the Phasix™ Mesh showed no detectable abscess or microbial colonization after being inoculated with MRSA, indicating superior safety and efficacy compared to hybrid meshes.

All hybrid meshes tested (Zenapro™, Ovitex™ 1S Permanent, and Ovitex™ 1S Resorbable) exhibited significant microbial colonization and higher abscess scores, highlighting their potential limitations in preventing infection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Contamination of hybrid hernia meshes compared to bioresorbable Phasix™ Mesh in a rabbit subcutaneous implant inoculation model. Lake, SP., Stoikes, NFN., Badhwar, A., et al.[2022]

In a study of 92 patients undergoing ventral hernia repair with the reinforced tissue matrix OviTex, only 2.7% experienced hernia recurrence after 12 months, indicating strong efficacy in preventing hernia reoccurrence.

The study reported a 26% rate of surgical site occurrences (SSOs), with 13% of those requiring further intervention, suggesting that while OviTex shows promise, there are still some complications to monitor in the long term.

NCBI (Pubmed)

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. DeNoto, G., Ceppa, EP., Pacella, SJ., et al.[2021]

The reinforced tissue matrix (RTM) mesh, specifically OviTex, has been shown to effectively prevent the inflammatory foreign body response typically associated with traditional polymer meshes in hernia repairs.

RTM promotes wound healing and supports the regeneration of functional tissue, which helps reinforce the abdominal wall and lower the risk of hernia recurrence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Polymer-Biologic Hybrid Hernia Construct: Review of Data and Early Experiences. Sawyer, M., Ferzoco, S., DeNoto, G.[2021]

In a study of 128 patients with stress urinary incontinence, all three sling types (Composix, TVT, and TVT-O) showed significant long-term improvements in continence, as measured by a 24-hour pad test, with average pad weights dropping from 30.4 g preoperatively to 5 g at 12 months.

While the Composix sling was cost-effective and provided similar continence outcomes, it was associated with a higher rate of minor complications and secondary procedures compared to the other sling types, raising concerns about its safety for future use.

NCBI (Pubmed)

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. Ben-Zvi, T., Moore, K., Haidar, N., et al.[2020]

In a study involving 30 male rats, both oxidized regenerated cellulose (ORC) and sodium hyaluronate/carboxymethylcellulose (HA/CMC)-coated polypropylene mesh (PPM) significantly reduced intra-abdominal adhesion formation compared to a control group that only received PPM.

There was no significant difference in adhesion formation between the ORC and HA/CMC groups, indicating that ORC is an effective adhesion barrier for intra-abdominal hernia repair, similar to HA/CMC.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevention of adhesion to prosthetic mesh in incisional ventral hernias: comparison of different barriers in an experimental model. Dilege, E., Coskun, H., Gunduz, B., et al.[2016]

In a study of 60 women with stress urinary incontinence, the needle-less single incision mini-slings (SIMS) technique using surgeon-tailored polypropylene mesh showed significantly less bleeding and lower rates of transient thigh pain compared to the standard trans-obturator tape (TOT) method.

Both SIMS and TOT had similar cure and improvement rates after three months, indicating that SIMS is a safe and effective alternative to TOT for treating female stress urinary incontinence.

NCBI (Pubmed)

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. Ali, E., E Shebl, S., Ibrahim, S.[2023]

In a prospective multicenter trial involving 67 women with anterior pelvic organ prolapse, the SRS implant demonstrated a high anatomical success rate of 94.3% and a subjective success rate of 95.7% after 36 months of follow-up.

The study reported minimal complications, with only a few cases of urinary retention and minor issues, suggesting that the SRS implant is a safe and effective alternative to traditional mesh repairs.

NCBI (Pubmed)

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. Levy, G., Padoa, A., Marcus, N., et al.[2022]

In a study of 87 women with stress urinary incontinence, the TVT-Secur (TVT-S) sling was associated with a significantly higher risk of a positive cough stress test (CST) result compared to the TVT-Obturator (TVT-O) sling, indicating less effective treatment for SUI.

Despite the differences in CST outcomes, both TVT-S and TVT-O slings led to similar improvements in quality of life and symptoms, as measured by the Pelvic Floor Distress Inventory and Pelvic Floor Impact Questionnaire at both 12 weeks and 1 year.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

TVT-Secur (Hammock) versus TVT-Obturator: a randomized trial of suburethral sling operative procedures. Hota, LS., Hanaway, K., Hacker, MR., et al.[2021]

In a study of 16,660 women undergoing incontinence procedures, those who had mesh procedures experienced significantly fewer immediate complications and a lower risk of needing further prolapse surgery compared to non-mesh surgeries.

However, for anterior and posterior compartment prolapse repairs, mesh procedures were associated with a higher risk of complications and repeat surgeries, indicating that mesh use for these types of repairs is not recommended.

NCBI (Pubmed)

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. Morling, JR., McAllister, DA., Agur, W., et al.[2022]

The thermally bonded nonwoven polypropylene mesh used in the OBTAPE procedure showed a high objective cure rate of 89.9% and a subjective cure rate of 77.5% for women with stress urinary incontinence, based on a study of 129 women followed for an average of 17.2 months.

Despite its effectiveness, the procedure had a complication rate of 6.2% for vaginal mesh erosion, indicating the importance of careful monitoring after surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Objective and subjective cure rates after trans-obturator tape (OBTAPE) treatment of female urinary incontinence. Deval, B., Ferchaux, J., Berry, R., et al.[2006]

In a study involving 10 female Yorkshire swine, the Ventralight ST/SorbaFix mesh showed significantly less inflammation, fibrosis, hemorrhage, and angiogenesis compared to the Physiomesh/Securestrap after 14 days, indicating a better histologic response.

Ventralight ST/SorbaFix also demonstrated greater strength of tissue ingrowth while maintaining similar mesh contracture and adhesion characteristics compared to Physiomesh/Securestrap, suggesting it may be a more effective option for laparoscopic ventral hernia repair.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ventralight ST and SorbaFix versus Physiomesh and Securestrap in a porcine model. Deeken, CR., Matthews, BD.[2021]

In a study of four patients who underwent laparoscopic ventral hernia repair using W3 mesh and Protack fixation, all patients required reoperation within 5 to 23 months due to recurrent or new hernias, indicating potential issues with the long-term efficacy of these materials.

The presence of severe adhesions to the mesh and fixation devices increased over time, complicating subsequent surgeries and raising concerns about the safety and validation of materials used in laparoscopic ventral hernia repairs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Adhesion after laparoscopic ventral hernia repair]. Zinther, NB., Fedder, J., Friis-Andersen, HU.[2008]

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]

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]

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

A Polymer-Biologic Hybrid Hernia Construct: Review of Data and Early Experiences. [2021]

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]

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]

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]

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]

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

TVT-Secur (Hammock) versus TVT-Obturator: a randomized trial of suburethral sling operative procedures. [2021]

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]

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

Objective and subjective cure rates after trans-obturator tape (OBTAPE) treatment of female urinary incontinence. [2006]

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

Ventralight ST and SorbaFix versus Physiomesh and Securestrap in a porcine model. [2021]

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

[Adhesion after laparoscopic ventral hernia repair]. [2008]