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

NCT05384600 | Completed

• 2 other identifiers: 8342310695
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Incisional Hernia

Keywords

Surgical Mesh; Acceptability; Prevention; Qualitative Research

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (2)

• Patient understanding of Incisional Hernia

  9 months

• Factors that modify acceptability of surgical mesh

  9 months

Study Arms (3)

Patients with Incisional Hernia

Patients who have undergone elective or emergency colonic resection between 2017 and 2020 at Cardiff and Vale UHB, who have subsequently received a diagnosis of Incisional Hernia. One-off self-completed patient questionnaire upon enrolment. Sub-set will be invited to participant in qualitative interview.

Patients without Incisional Hernia

Patients who have undergone elective or emergency colonic resection between 2017 and 2020 at Cardiff and Vale UHB, who have not subsequently been diagnosed with (or suspected of having) incisional hernia. One-off self-completed patient questionnaire upon enrolment. Sub-set will be invited to participant in qualitative interview.

Patients due to undergo surgery

Patients who are due to undergo elective colonic surgery within Cardiff and Vale UHB, who have an unknown risk of- , and may or may not go on to develop-, incisional hernia. One-off self-completed patient questionnaire upon enrolment. Sub-set will be invited to participant in qualitative interview.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Cardiff and Vale University Health Board: lead

Study Sites (1)

Julie Cornish

Cardiff, CF14 4XW, United Kingdom

Location

Related Publications (1)

• Smith L, Meggy A, Watts T, Knight L, Torkington J, Cornish J. Incisional hernia prevention: risk-benefit from a patient perspective (INVITE) - protocol for a single-centre, mixed-methods, cross-sectional study aiming to determine if using prophylactic mesh in incisional hernia prevention is acceptable to patients. BMJ Open. 2022 Dec 30;12(12):e069568. doi: 10.1136/bmjopen-2022-069568.

  PMID: 36585153 DERIVED

MeSH Terms

Conditions

Incisional Hernia

Condition Hierarchy (Ancestors)

Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes

Study Officials

• Julie Cornish

  Cardiff and Vale University Health Board

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2022
• First Posted: May 20, 2022
• Study Start: June 17, 2022
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: July 20, 2023

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)