~64 spots leftby Oct 2026

Suture vs Mesh Repair for Incisional Hernia

Palo Alto (17 mi)
Overseen byClayton Petro, MD
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: N/A
Recruiting
Sponsor: Clayton Petro
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.
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.12359
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.24589
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.23679

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.

Treatment Details

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.
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.
Incisional hernia repair is already approved in United States, European Union, Canada, Japan, China, Switzerland for the following indications:
πŸ‡ΊπŸ‡Έ Approved in United States as Incisional hernia repair for:
  • Incisional hernias
πŸ‡ͺπŸ‡Ί Approved in European Union as Incisional hernia repair for:
  • Incisional hernias
πŸ‡¨πŸ‡¦ Approved in Canada as Incisional hernia repair for:
  • Incisional hernias
πŸ‡―πŸ‡΅ Approved in Japan as Incisional hernia repair for:
  • Incisional hernias
πŸ‡¨πŸ‡³ Approved in China as Incisional hernia repair for:
  • Incisional hernias
πŸ‡¨πŸ‡­ Approved in Switzerland as Incisional hernia repair for:
  • Incisional hernias

Find a clinic near you

Research locations nearbySelect from list below to view details:
Vanderbilt UniversityNashville, TN
Cleveland Clinic Main CampusCleveland, OH
University of FloridaGainesville, FL
The Ohio State University Wexner Medical CenterColumbus, OH
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Who is running the clinical trial?

Clayton PetroLead Sponsor
The Cleveland ClinicLead Sponsor

References

Incisional hernia treatment with progressive pneumoperitoneum and retromuscular prosthetic hernioplasty. [2016]Major incisional hernias of the abdominal wall often pose a serious surgical problem. The choice between simple suture repair and mesh repair remains uncertain.
Primary incisional hernia repair with or without polypropylene mesh: a report on 384 patients with 5-year follow-up. [2022]Several studies have claimed that mesh repair of incisional hernia lowers recurrence rates when compared to suture repair. We investigated the relative effectiveness of mesh and suture repair in a large homogeneous cohort of patients with primary incisional hernia.
Suture versus mesh repair for incisional hernia. [2008]To compare suture with mesh repair, for incisional hernia in terms of early and late outcomes.
Comparison of laparoscopic and open repair of incisional and primary ventral hernia: results of a prospective randomized study. [2018]Incisional hernia is an important complication of abdominal surgery. Its repair has progressed from a primary suture repair to various mesh repairs and laparoscopic repair. Laparoscopic mesh repair is a promising alternative, and in the absence of consensus, needs prospective randomized controlled trials.
Laparoscopic suture repair of selected incisional hernias: a simple technique. [2007]An incisional hernia is a common condition that can be repaired by laparoscopic surgery, with the use of a prosthetic mesh. There are certain situations, however, in which the use of a mesh might be contraindicated, inadvisable, unnecessary, or unavailable. In this paper, we report on a new laparoscopic technique for the suture repair of incisional hernias that may be safely used under such conditions in selected patients.
Open mesh repair of incisional hernia using a sublay technique: long-term follow-up. [2022]Reported results of incisional hernia repair are poor with high recurrence rates unless prosthetic mesh is used. Mesh gives improved results, but certain techniques are associated with a high incidence of infections, fistulas, and seromas. This study reports the results of a consecutive series of incisional hernias repaired using an open sublay technique with retromuscular mesh placement. The primary endpoint was hernia recurrence. Secondary endpoints were complications and long-term discomfort.
Suture Versus Mesh Repair in Primary and Incisional Ventral Hernias: A Systematic Review and Meta-Analysis. [2022]Today, ventral hernia repair is predominantly performed with meshes. There is no meta-analysis of high quality evidence that compares the results of suture to mesh repair. The objective of this systematic review with meta-analysis is to compare patient centred outcomes of suture versus mesh repair.
Open versus laparoscopic incisional hernia repair: nationwide database study. [2021]Although laparoscopic repair of incisional hernias decreases the incidence of wound complications compared with open repair, there has been rising concern related to intraperitoneal mesh placement. The aim of this study was to examine outcomes after open or laparoscopic elective incisional hernia mesh repair on a nationwide basis.
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]Mesh has been the acceptable standard for incisional hernia repair regardless of hernia size. It is not clear whether there is a size of incisional hernias in whom repair would be best performed without mesh. This study aims to compare outcomes of mesh versus suture repairs for incisional hernias