Suture vs Mesh Repair for Incisional Hernia

Recruiting at3 trial locations

Overseen by Clayton Petro, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Clayton Petro

Disqualifiers: Pregnancy, Hernia size, others

No Placebo Group

Approved in 6 Jurisdictions

Trial Summary

What is the purpose of this trial?

This trial compares two methods of hernia repair: using a mesh or using stitches. It focuses on patients with hernias that are 2-6 cm in size. The goal is to see if using stitches is just as effective as using mesh in improving patients' quality of life after surgery.

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.

What data supports the idea that Suture vs Mesh Repair for Incisional Hernia is an effective treatment?

The available research shows that using mesh for incisional hernia repair tends to lower the chances of the hernia coming back compared to using just stitches (suture repair). One study followed 384 patients for five years and found that mesh repair had better results in preventing hernia recurrence. Another study highlighted that mesh is generally the standard choice for hernia repair because it provides better long-term outcomes. However, there are some concerns about complications like infections when using mesh, but these are often outweighed by the benefits of reduced recurrence. ^{1 2 3 4 5}

What safety data exists for suture vs mesh repair in incisional hernia treatment?

Existing safety data for suture vs mesh repair in incisional hernia treatment includes several studies. One study with a 5-year follow-up on 384 patients suggests that mesh repair lowers recurrence rates compared to suture repair. Another study questions the necessity of mesh for hernias 2 cm or less, comparing outcomes of mesh versus suture repairs. Laparoscopic suture repair is presented as a safe alternative in certain conditions where mesh is not advisable. A nationwide database study indicates that laparoscopic repair reduces wound complications compared to open repair, but there are concerns about intraperitoneal mesh placement. Lastly, a prospective randomized study compares laparoscopic and open repairs, highlighting the need for further trials to establish consensus on the best approach. ^{1 3 6 7 8}

Is incisional hernia repair a promising treatment?

Yes, incisional hernia repair is promising because using mesh in the repair can lower the chances of the hernia coming back compared to using just stitches. This makes it a reliable option for treating incisional hernias. ^{1 2 3 6 9}

Research Team

Clayton Petro, MD

Principal Investigator

The Cleveland Clinic

Eligibility Criteria

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

My hernia is between 2 and 6 cm wide.

I am over 18 years old.

Non-emergent case

Exclusion Criteria

I have a primary hernia.

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

Emergent cases

Trial Timeline

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

Treatment Details

Interventions

• Incisional hernia repair (Other)

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.

Participant Groups

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 Canada, Japan, China, Switzerland for the following indications:

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+

David Peter

The Cleveland Clinic

Chief Medical Officer

MD, board-certified in Hospice and Palliative Medicine

Tomislav Mihaljevic

The Cleveland Clinic

Chief Executive Officer since 2018

MD from University of Zagreb School of Medicine

Findings from Research

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 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]

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]

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]

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]

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]

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 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]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Primary incisional hernia repair with or without polypropylene mesh: a report on 384 patients with 5-year follow-up. [2022]

2. Saudi Arabia pubmed.ncbi.nlm.nih.gov

Suture versus mesh repair for incisional hernia. [2008]

3. United States 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. [2023]

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

Suture Versus Mesh Repair in Primary and Incisional Ventral Hernias: A Systematic Review and Meta-Analysis. [2022]

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

Open mesh repair of incisional hernia using a sublay technique: long-term follow-up. [2022]

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

Laparoscopic suture repair of selected incisional hernias: a simple technique. [2007]

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

Open versus laparoscopic incisional hernia repair: nationwide database study. [2021]

8. Germany pubmed.ncbi.nlm.nih.gov

Comparison of laparoscopic and open repair of incisional and primary ventral hernia: results of a prospective randomized study. [2018]

9. Germany pubmed.ncbi.nlm.nih.gov

Incisional hernia treatment with progressive pneumoperitoneum and retromuscular prosthetic hernioplasty. [2016]