Incisional HerniaINVITENCT05384600
Incisional Hernia Prevention: Risk-benefit From a Patient's Perspective
An observational study of Incisional Hernia, run by Cardiff and Vale University Health Board at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Incisional Hernia
- How many people
- 120 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 17 Jun 2022to 30 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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)
Who may be able to join
- 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.
Show all 17Show fewer
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Keywords
- Surgical Mesh, Acceptability, Prevention, Qualitative Research
- Medical subject headings
- Incisional Hernia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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:
- Understanding of surgical mesh B) Perceptions of surgical mesh risk C) Perceptions of surgical mesh benefit
Measured: 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:
- Perception of risk in relation to incisional hernia B) Perception of personalised risk scoring C) Impact of A) and B) on surgical mesh use
Measured: 12 months
Secondary outcomes (2)
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.
Measured: 9 months
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 .
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2022
- Study start17 Jun 2022
- Primary completion30 Jun 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Incisional HerniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cardiff and Vale University Health Board
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Julie Cornish, Principal investigator, Cardiff and Vale University Health Board
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05384600
- Sponsor's protocol ID
- 8342
- Other IDs
- 310695
- Acronym
- INVITE
- Status last verified
- Jul 2022
- First submitted
- 17 May 2022
- Last updated
- 20 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36585153
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incisional Hernia Prevention: Risk-benefit From a Patient's Perspective
- ClinicalTrials.gov ID
- NCT05384600
- Acronym / sponsor ID
- INVITE / 8342
- Conditions
- Incisional Hernia
- Keywords
- Surgical Mesh, Acceptability, Prevention, Qualitative Research
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Cardiff and Vale University Health BoardOther government
- Study start
- 17 Jun 2022 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 20 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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)
Key inclusion criteria (17 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Acceptability of prophylactic surgical mesh use to patients
Time frame: 12 months
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
Impact of incisional hernia risk scores on surgical mesh acceptibility
Time frame: 12 months
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
2 secondary outcomes
Patient understanding of Incisional Hernia
Time frame: 9 months
Factors that modify acceptability of surgical mesh
Time frame: 9 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2023.
- Derived from this study: PubMed 36585153Smith 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.
- Individual participant dataSharing planned: No
Related trials for Incisional Hernia
Not yet recruitingObservational study
Pilot Study on the Effectiveness and Safety of OPTILENE® SILVER MESH ELASTIC in Prevention of Surgical Site Infection (SSI) and Incisional Hernia (IH)
Abdominal Aortic Aneurysm, Morbid Obesity
Active, not recruitingObservational study
Assessment of GORE® SYNECOR Biomaterial in Focused Patient Populations and Long-Term Application
Hernia, Ventral, Hernia Incisional
Not yet recruiting
Suture Choice for Ostomy Creation
Ostomy - Ileostomy or Colostomy, Stoma Complications
RecruitingObservational study
Patient-Specific Biomechanical Modeling of Incisional Hernias Using Artificial Intelligence and Finite Element Analysis
Incisional Hernia
Recruiting
GORE® ENFORM Biomaterial Product Study
Hernia, Ventral, Hernia, Hiatal
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julie Cornish principal investigator
Cardiff and Vale University Health Board
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Incisional Hernia, run by Cardiff and Vale University Health Board at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability of prophylactic surgical mesh use to patients (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05384600, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2023.