Clinical trial NCT05384600: Incisional Hernia Prevention: Risk-benefit From a Patient's Perspective
Official title: Incisional Hernia Prevention: Risk-benefit From a Patient's Perspective
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Incisional Hernia
Keywords: Surgical Mesh
Acceptability
Prevention
Qualitative Research
Lead sponsor: Cardiff and Vale University Health Board
Sponsor class: OTHER_GOV
First posted: 2022-05-20
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: In order to explore patient perceptions of surgical mesh use in the context of incisional hernia prevention, we will identify three groups of patients, from the department of surgery, Cardiff and Vale University Health Board:

1. Patients that have previously undergone abdominal surgery and subsequently been diagnosed with incisional hernia. (n=150)
2. Patients that have previously undergone abdominal surgery and have not subsequently developed or been diagnosed with incisional hernia. (n=150)
3. Patients that are currently due to undergo abdominal surgery, and may or may not subsequently develop incisional hernia. (n=20)

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Acceptability of prophylactic surgical mesh use to patients
timeFrame: 12 months
measure: Impact of incisional hernia risk scores on surgical mesh acceptibility
timeFrame: 12 months
Secondary outcomes:
measure: Patient understanding of Incisional Hernia
timeFrame: 9 months
measure: Factors that modify acceptability of surgical mesh
timeFrame: 9 months
Other outcomes:
Locations:
city: Cardiff
country: United Kingdom
facility: Julie Cornish
Study officials:
affiliation: Cardiff and Vale University Health Board
name: Julie Cornish
role: PRINCIPAL_INVESTIGATOR
References: