Suture vs Mesh Repair for Incisional Hernia

Recruiting at 3 trial locations

Overseen By Sara Maskal, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Clayton Petro

Disqualifiers: Pregnancy, Hernia size, others

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

Approved in 6 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 30

Duration: Immediate postoperative period

154 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if repairing incisional hernias (a type of abdominal wall hernia) with stitches alone is as effective as using a mesh. Researchers seek to identify which method provides a better quality of life one year after surgery. Participants will undergo either a suture repair or a mesh repair, both utilizing modern surgical techniques. Suitable candidates for this trial have an incisional hernia measuring 2-6 cm wide and have not undergone previous mesh repair at the hernia site. As an unphased trial, this study offers participants the chance to contribute to valuable research that could enhance future hernia repair methods.

Do I need to stop my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that both suture and mesh methods for fixing incisional hernias have been studied for safety. Studies on suture repair indicate it can be safe, especially with modern techniques, and it carries fewer risks of complications like infections compared to mesh.

However, mesh repair presents specific risks. The mesh can sometimes move or shrink inside the body, potentially causing problems. Some patients have experienced ongoing pain or infections related to the mesh, though these issues are uncommon.

Overall, both methods are generally safe, but each has its own possible side effects. Discussing with a doctor is important to determine which option best suits individual needs. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about this trial because it compares two different techniques for repairing incisional hernias, which is a common surgical issue. Traditionally, hernias are often repaired using a mesh, which provides additional support to the weakened area. However, this trial is exploring the effectiveness of using only sutures, with modern techniques, to fix the hernia. This suture-only approach could potentially reduce complications associated with mesh, such as infection or chronic pain. By comparing these methods, the study aims to determine if sutures alone can provide a reliable and less invasive option for patients.

What evidence suggests that this trial's treatments could be effective for incisional hernia repair?

This trial will compare two methods for incisional hernia repair: hernia repair with mesh and primary closure with suture alone. Research has shown that using mesh for incisional hernias can reduce recurrence. Studies have found that repairing the hernia by stitching the muscle back together without mesh can lead to higher recurrence rates, with one study finding that up to 48% of hernias fixed with stitches alone could return. However, newer stitching techniques are improving and might lead to better outcomes. The trial aims to determine if these new stitching methods can provide the same quality of life as mesh repairs. ^{5 6 7 8 9}

Who Is on the Research Team?

Clayton Petro, MD

Principal Investigator

The Cleveland Clinic

Are You a Good Fit for This Trial?

Adults over 18 with a non-emergency incisional hernia measuring 2-6cm, who previously had ventral hernia repair without mesh. Not for those with prior mesh at the repair site, other wound classes, emergency cases, under 18s, pregnant individuals or hernias outside of the size range.

Inclusion Criteria

Non-emergent case

My hernia is between 2 and 6 cm wide.

I am over 18 years old.

Exclusion Criteria

I have a primary hernia.

My ventral hernia is either smaller than 2cm or larger than 6cm.

Emergent cases

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo incisional hernia repair with either mesh or suture

Immediate postoperative period

Follow-up

Participants are monitored for quality of life, pain intensity, recurrence, complications, and cost effectiveness

5 years

Follow-up assessments at 30 days, 1 year, 2 years, and 5 years

What Are the Treatments Tested in This Trial?

Interventions

• Incisional hernia repair

Trial Overview This study compares quality of life after one year in patients receiving incisional hernia repairs using either sutures alone or with mesh. It's a randomized trial to see if suture-only repair is just as good as mesh repair based on HerQLes scores.

How Is the Trial Designed?

Group I: Hernia repair with mesh (Control arm) Active Control 1 Intervention

Participants will undergo incisional hernia repair with prolene mesh in the retrorectus position with at least 4cm of overlap.

Group II: Primary closure (Intervention arm) Active Control 1 Intervention

Participants will undergo incisional hernia repair with suture alone using modern surgical techniques.

Incisional hernia repair is already approved in United States, European Union, Canada, Japan, China, Switzerland for the following indications:

Approved in United States as Incisional hernia repair for:

• Incisional hernias

Approved in European Union as Incisional hernia repair for:

• Incisional hernias

Approved in Canada as Incisional hernia repair for:

• Incisional hernias

Approved in Japan as Incisional hernia repair for:

• Incisional hernias

Approved in China as Incisional hernia repair for:

• Incisional hernias

Approved in Switzerland as Incisional hernia repair for:

• Incisional hernias

Who Is Running the Clinical Trial?

Clayton Petro

Lead Sponsor

Trials

5

Recruited

1,600+

The Cleveland Clinic

Lead Sponsor

Trials

1,072

Recruited

1,377,000+

Published Research Related to This Trial

In a study of 123 patients with incisional hernias, mesh repair significantly reduced the recurrence rate to 5.8% compared to 20.8% for suture repair, indicating that mesh is more effective for long-term outcomes.

Both repair methods had similar rates of wound infections (5.5% for suture vs. 3.9% for mesh), suggesting that mesh repair does not increase the risk of early complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Suture versus mesh repair for incisional hernia. Al-Salamah, SM., Hussain, MI., Khalid, K., et al.[2008]

Laparoscopic mesh repair for incisional and ventral hernias resulted in a significantly shorter hospital stay (1.47 days) compared to open retro-rectus mesh repair (3.43 days), indicating a quicker recovery for patients.

The laparoscopic approach also had fewer wound-related infections (6%) compared to the open repair group (33%), suggesting it may be a safer option with fewer complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of laparoscopic and open repair of incisional and primary ventral hernia: results of a prospective randomized study. Misra, MC., Bansal, VK., Kulkarni, MP., et al.[2018]

In a study of 125 patients undergoing incisional hernia repair using an open sublay technique with retromuscular mesh, the recurrence rate was low at only 4%, indicating high efficacy of this surgical method.

The procedure had a favorable safety profile, with no early wound infections and only two cases of mesh infection requiring removal, suggesting that this technique can be performed with acceptable complication rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Open mesh repair of incisional hernia using a sublay technique: long-term follow-up. Kurzer, M., Kark, A., Selouk, S., et al.[2022]

In a study of 446 patients with primary incisional hernia followed for an average of 5 years, mesh repair significantly reduced recurrence rates to 5% compared to 18% for suture repair, indicating its long-term effectiveness.

While mesh repair was associated with longer operating times and a higher incidence of seroma (12.7%), it is recommended for use over suture repair, especially for larger hernias, due to its lower recurrence rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Primary incisional hernia repair with or without polypropylene mesh: a report on 384 patients with 5-year follow-up. Sauerland, S., Schmedt, CG., Lein, S., et al.[2022]

In a study of 77 patients with large incisional hernias, the use of progressive pneumoperitoneum before surgery was well-tolerated and did not lead to any postoperative deaths, indicating a safe preparation method.

The retromuscular mesh repair technique resulted in a low recurrence rate of only 2.6% for incisional hernias, suggesting it is an effective surgical option for this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Incisional hernia treatment with progressive pneumoperitoneum and retromuscular prosthetic hernioplasty. Toniato, A., Pagetta, C., Bernante, P., et al.[2016]

In a study of 352 patients with incisional hernias smaller than 2 cm, repairs without mesh showed similar recurrence rates compared to mesh repairs after one year (15% vs 24%), suggesting that non-mesh repairs can be effective for small hernias.

Repairs without mesh were associated with significantly fewer postoperative complications (1% vs 11%) within 30 days, indicating a potential safety advantage for select patients with small incisional hernias.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mesh versus suture repair of incisional hernias 2 cm or less: Is mesh necessary? A propensity score-matched analysis of the abdominal core health quality collaborative. Wehrle, CJ., Prabhu, AS., Thompson, R., et al.[2023]

A new laparoscopic technique for suture repair of incisional hernias has been developed for cases where using a prosthetic mesh is not advisable or available.

This technique offers a safe alternative for repairing incisional hernias in selected patients, expanding treatment options for those who cannot use traditional mesh methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Laparoscopic suture repair of selected incisional hernias: a simple technique. Ballester, P., Ammori, BJ.[2007]

Laparoscopic repair of incisional hernias resulted in significantly lower rates of readmission (16.2% vs. 19.3%) and reoperation for complications (7.0% vs. 12.5%) compared to open repair, based on a study of 5,378 patients over a median follow-up of 4 years.

Despite a higher incidence of bowel obstruction or resection after laparoscopic repair, it is still recommended for fascial defects between 2 and 6 cm due to its overall lower early complication rates and reduced need for recurrence repair.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Open versus laparoscopic incisional hernia repair: nationwide database study. Henriksen, NA., Friis-Andersen, H., Jorgensen, LN., et al.[2021]

Mesh repair for ventral hernia significantly reduces the risk of recurrence compared to suture repair, with a relative risk of 0.36 based on a meta-analysis of 10 randomized controlled trials involving 1215 patients.

While mesh repair is effective in preventing recurrences, it may increase the risk of chronic pain in patients without recurrence, particularly when the mesh is fixed in a sublay position.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Suture Versus Mesh Repair in Primary and Incisional Ventral Hernias: A Systematic Review and Meta-Analysis. Mathes, T., Walgenbach, M., Siegel, R.[2022]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40760387/

Early outcomes of contaminated midline incisional hernia ... This study evaluates the early clinical outcomes following mesh suture closure in clean-contaminated and contaminated incisional hernia repairs.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3840708/

A double blind randomized controlled trial comparing ... The PRIMA trial will provide level 1b evidence whether mesh augmented midline abdominal closure reduces incisional hernia incidence in high risk groups. Trial ...

3. frontierspartnerships.org frontierspartnerships.org/journals/journal-of-abdominal-wall-surgery/articles/10.3389/jaws.2025.14573/full

Mesh Suture and Mesh Strips to Prevent Incisional Hernia ... We evaluated clinical outcomes for mesh suture and its precursor, mesh strip, in clinical trials of abdominal wall closure or ventral hernia repair.

4. nejm.org nejm.org/doi/full/10.1056/NEJM200008103430603

A Comparison of Suture Repair with Mesh Repair for ... After repair of recurrent incisional hernias, recurrence rates of up to 48 percent have been reported. These studies of suture repairs and mesh ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S0039606024006901

Primary and incisional hernias should be considered ... This study investigated whether differences in the risk of surgical outcomes among primary and incisional hernias are solely due to the hernia type.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12321942/

Early outcomes of contaminated midline incisional hernia ... This study evaluates the early clinical outcomes following mesh suture closure in clean-contaminated and contaminated incisional hernia repairs.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10788045/

Incisional Hernia: A Surgical Complication or Medical ... Elective repair improves QOL and prevents sinister outcomes associated with emergency IH repair. The watchful wait strategy should be reviewed, ...

8. fda.gov fda.gov/medical-devices/implants-and-prosthetics/surgical-mesh-used-hernia-repair

Surgical Mesh Used for Hernia Repair For hernia repair with mesh, additional adverse events include migration or shrinkage (contraction) of the mesh itself, which may more ...

9. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1043148909000165

Complications of Incisional Hernia Repair More serious long-term complications include chronic pain, chronic mesh infections, as well as the rare, but highly morbid, enterocutaneous fistula involving ...