NCT05384600

Incisional Hernia Prevention: Risk-benefit From a Patient's Perspective

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 120 (actual)
• Sponsor: Cardiff and Vale University Health Board · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Incisional Hernia (IH) is a common complication of abdominal surgery and causes serious morbidity to patients. IH formation is multifactorial and its risk varies from patient to patient. Risk-predictive tools have been developed to identify patients at high risk of IH before their initial operation, with high-risk patients possibly being offered the use of prophylactic mesh, placed at the end of the operation to prevent IH from forming. With controversy surrounding the use of mesh in other types of surgery, however, it is not known if mesh use is acceptable to patients. This study aims to assess how patients feel about prophylactic mesh and whether it is acceptable to them.

Detailed description

Incisional hernias are bulges through the abdominal wall that occur at the site of previous surgery. They are common, affecting between 12-20% of patients undergoing abdominal surgery, can pose a significant cost to the NHS and cause serious morbidity to patients. Risk-prediction tools are being developed with the aim of working out a person's risk of developing an incisional hernia before their operation. It is hoped that this will allow surgeons to give patients an idea of what their risk is before the operation happens so that patients can understand if they are at high, medium or low risk, and what they might be able to do about it before the operation. For patients that are "high risk" for developing an incisional hernia, it may be possible to use a synthetic mesh, similar to those used to fix groin hernias. This would be placed in the wound at the end of the initial operation to strengthen the wound to try and reduce the chance of developing an incisional hernia, however to date, no studies have looked at whether patients would find this acceptable. This study aims to establish whether mesh placed to prevent hernias during the initial surgery would be acceptable to patients. This, in turn, can be used to inform the design of future research studies surrounding the use of surgical mesh.

Conditions

• Incisional Hernia

Timeline

• Start date: 2022-06-17
• Primary completion: 2023-06-30
• Completion: 2023-06-30
• First posted: 2022-05-20
• Last updated: 2023-07-20

Locations

1 site across 1 country: United Kingdom