What side effects are associated with this type of intervention?

Suture repair for incisional hernia can lead to complications such as hernia recurrence, postoperative pain, and infection at the suture site. Mesh repair, while generally reducing the recurrence rate compared to suture repair, can also cause complications including infection, chronic pain, seroma formation, and mesh migration or rejection. Both methods require careful consideration of patient-specific factors to minimize risks and optimize outcomes.

What prior FDA approvals exist?

The FDA has approved various synthetic and biological meshes for the treatment of incisional hernias. These meshes are used to reinforce the hernia site and reduce the risk of recurrence. Commonly used synthetic meshes include polypropylene and polyester meshes, while biological meshes are derived from human or animal tissues. Suture repair, which involves mechanically closing the hernia with sutures, does not typically require specific FDA approval for the sutures themselves, as they are standard medical devices. Both methods are widely studied and used in clinical practice to improve patient outcomes and reduce hernia recurrence rates.

What other types of research exist?

Promising novel alternatives to traditional suture and mesh repair for incisional hernia include: 1) Robotic-assisted laparoscopic repair, which offers precision and potentially reduced recovery times; 2) Hybrid approaches combining laparoscopic and open techniques for better outcomes; 3) Use of crosslinked and non-crosslinked biologic prostheses, which may offer improved integration and reduced recurrence rates; 4) Prophylactic biological mesh reinforcement, which has shown feasibility and safety in initial studies. These alternatives are being explored for their potential to enhance patient outcomes and reduce complications.

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Suture vs Mesh Repair for Incisional Hernia

N/A

Recruiting

Led By Clayton Petro, MD

Research Sponsored by Clayton Petro

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While not explicitly stated here, common side effects from such surgeries may include pain at the surgery site, infection risk, bleeding complications and potential for recurrence of the hernia.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Complications

Cost effectiveness

Diaphragmatic Hernia

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Active Control

Group I: Hernia repair with mesh (Control arm)Active Control1 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 Control1 Intervention

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

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Suture repair for incisional hernia involves mechanically closing the hernia defect using sutures, relying on the strength of the tissue and sutures to maintain closure. Mesh repair involves placing a synthetic or biological mesh over or under the hernia defect to reinforce the area, acting as a scaffold that integrates with the surrounding tissue to provide additional strength and reduce recurrence risk. Understanding these mechanisms helps patients and doctors make informed decisions about which treatment may offer better long-term outcomes and lower recurrence rates.

Prophylactic Mesh After Midline Laparotomy: Evidence is out There, but why do Surgeons Hesitate?A systematic review on surgical treatment of primary epigastric hernias.Prophylactic biological mesh reinforcement versus standard closure of stoma site (ROCSS): a multicentre, randomised controlled trial.