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

Incisional Hernia Clinical Trial

— INVITE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05384600
• Other study ID #: 8342
• Secondary ID: 310695
• Status: Completed
• Start date: June 17, 2022
• Est. completion date: June 30, 2023

Study information

• Verified date: July 2022
• Source: Cardiff and Vale University Health Board
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: June 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Group 1 Patients who have previously undergone abdominal surgery, and subsequently developed incisional hernia.

• Over the age of 18 years old

• Able and willing to provide valid informed consent

• Undergone elective or emergency colonic resection >12 months ago

• Clinical or radiological diagnosis of incisional hernia.

Where possible, patients will only be approached to participate where their clinical record indicates they are aware that they have a diagnosis of incisional hernia.

Group 2 Patients who have undergone abdominal surgery, but have not subsequently developed incisional hernia.

• Over the age of 18 years old

• Able and willing to provide valid informed consent

• Undergone emergency abdominal surgery > 12 months ago OR elective colonic resection > 12 months ago

• Do not have a clinical or radiological diagnosis of Incisional hernia (or suspected incisional hernia)

Group 3 Patients who are due to undergo abdominal surgery, who may or may not subsequently develop incisional hernia.

• Over the age of 18 years old

• Able and willing to provide valid informed consent

• Scheduled for elective colonic resection in Cardiff and Vale UHB.

• No history of previous laparotomy.

Where possible, attempts will be made to identify patients undergoing colonic resection for benign disease.

Exclusion Criteria:

All participants (groups 1, 2 & 3)

• Unable or unwilling to give informed consent

• Palliative diagnosis either at time of surgery, or since

• Inability to understand or complete study questionnaires, due to intellectual or cognitive impairment or due to insufficient English-language skills

Related Conditions & MeSH terms

• Hernia
• Incisional Hernia

Locations

Country	Name	City	State
United Kingdom	Julie Cornish	Cardiff

Sponsors (1)

Lead Sponsor	Collaborator
Cardiff and Vale University Health Board

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acceptability of prophylactic surgical mesh use to patients	A combination of qualitative and quantitative methods will explore patient perceptions of prophylactic mesh. Non-validated questionnaire developed based on Health Belief Model Theory, consisting of multiple 5-point Likert scale (min.1, max. 5), used in combination with semi-structured interviews to evaluate: A) Understanding of surgical mesh B) Perceptions of surgical mesh risk C) Perceptions of surgical mesh benefit	12 months
Primary	Impact of incisional hernia risk scores on surgical mesh acceptibility	A combination of qualitative and quantitative methods will explore how incisional hernia risk impacts perception of surgical mesh use; Non-validated questionnaire developed based on Health Belief Model Theory, consisting of multiple 5-point Likert scale (min.1, max. 5), used in combination with semi-structured interviews to evaluate: A) Perception of risk in relation to incisional hernia B) Perception of personalised risk scoring C) Impact of A) and B) on surgical mesh use	12 months
Secondary	Patient understanding of Incisional Hernia	Patient-reported understanding of incisional hernia will be assessed using non-validated questionnaire, developed based on the Health Belief Model Theory. Multiple 5-point Likert scale questions, where 1 (min.) represents least perceived understanding possible and 5 (max.) represents most perceived understanding possible.	9 months
Secondary	Factors that modify acceptability of surgical mesh	Semi-structured interviews will use qualitative research techniques to explore factors that impact patient acceptability of surgical mesh .	9 months