Inguinal HerniaHIPPONCT05748886
A Global Prospective Study on Inguinal Hernia Surgery
An observational study of Inguinal Hernia and Groin Hernia, run by University of Birmingham at 1 site in United Kingdom.
Trial summary
The primary aim of the HIPPO study is to identify compliance to audit standards (pre-operative and intraoperative) standards for the repair and management of inguinal hernia. A prospective, multicentre, cohort study will be delivered by NIHR Unit on Global Surgery globally. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Inguinal Hernia, Groin Hernia, Surgery
- How many people
- 5,000 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 31 Jan 2023to 15 Jul 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Consecutive patients during the selected study period undergoing elective or emergency primary inguinal hernia repair through any operative approach.
Who may be able to join
- Summary: Consecutive patients during the selected study period undergoing elective or emergency primary inguinal hernia repair through any operative approach.
- Age: Paediatric and adult patients
- Procedure: Primary inguinal hernia repair, where this is the main procedure. For patients with bilateral inguinal hernias, data should be entered only for the larger of the two.
- Approach: Open groin incision, laparoscopic, laparoscopic assisted, laparoscopic converted, robotic, robotic converted procedures are all eligible. Patients with open incisions other than groin incision (e.g. laparotomy) are excluded.
- Urgency: Patients undergoing planned (elective) surgery or emergency surgery
Who cannot join
- Procedures:
- Recurrent inguinal hernias
- Surgeries where inguinal hernia repair is not the main procedure, but performed as an additional procedure (eg patient operated for colon cancer and undergoing inguinal hernia repair during the same operation).
- If patients are undergoing repair of two different types of hernia they can be included if the inguinal hernia repair is the main operation. (e.g. patient undergoing both inguinal and umbilical hernia repair). However, if the inguinal hernia repair is a secondary procedure to a larger non-inguinal hernia repair, patients should be excluded (e.g patient undergoing both large incisional hernia repair and inguinal hernia repair).
- Laparoscopic converted to open midline procedures
- Patients undergoing surgery with intent of repair of inguinal hernia, where no hernia inguinal hernia was identified (e.g. intra-operative findings of adenopathy, femoral hernia, obturator hernia)
Show all 14Show fewer
- Return to theatre:
- Each individual patient should only be included in the study once. Patients returning to theatre due to complications following earlier surgery can only be included if their index procedure has not already been included in the HIPPO audit.
- Patients with bilateral hernias undergoing repair with two separate procedures in two different times, should only be included for the first procedure.
- Data should be collected on consecutive patients operated at each centre during the data collection period. This means that all eligible patients should be included.
- Strategies to identify consecutive eligible patients could include:
- Daily review of elective theatre lists.
- Daily review of handover sheets and ward lists.
- Daily review of theatre logbooks (both elective).
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
University of Birmingham
Birmingham
Maria Picciochi, + 44 (0) 121 378121, maria.picciochi@gmail.com
About this study
Official title: Global Cohort Study: Hernias, Pathway and Planetary Outcomes for Inguinal Hernia Surgery
The primary aim of the HIPPO study is to identify compliance to audit standards (pre-operative and intraoperative) standards for the repair and management of inguinal hernia.
A prospective, multicentre, cohort study will be delivered by NIHR Unit on Global Surgery globally. Mini-teams of up to five collaborators per data collection period will prospectively collect data over a continuous 28-day period at each participating centre. This will be on consecutive patients undergoing elective and/or emergency primary inguinal hernia surgery, with follow-up to 30 postoperative days.
Read the detailed description
Inguinal hernia surgery is one of the most common elective operations around the world. It was significantly down-prioritised during the pandemic, with fewer planned procedures and a likely increase in a global backlog. According to the most updated data, there are 74,822 patients waiting for inguinal hernia repair in the United Kingdom's National Health Service (NHS), although the recommended expected waiting time should not exceed 18 weeks. It is likely that other countries face the same problem, although such granular data does not exist. Additionally, while waiting for an elective repair, complications of inguinal hernia might arise and an emergency surgery might be needed. Identifying the scale of the global backlog at a global level will inform policy makers on the best strategies to optimise this elective surgical pathway.
Different surgical techniques exist, with different mesh and non-mesh techniques being described. The most up-to-date international guidelines recommend Lichenstein as the gold-standard for open repair of inguinal hernias, but a more tailored approach is recommended. The patient, the hernia type, and the surgeon's expertise will influence the choice of surgical technique which leads to a wide variation worldwide. Additionally, in areas where there is a deficit of surgeons, task sharing and task shifting might be implemented. Identification of this practice across the world and the outcomes associated with it will inform future research in this area.
Finally, as inguinal hernia repair is a very common procedure, it can reflect the global uptake of environmentally sustainable measures in elective surgery. Achieving a net zero health system is only possible if reducing the carbon output from operating theatres is included. Different countries might have different protocols and measures adopted to be environmentally sustainable that could be used in different settings. Understanding the baseline point of these practices is extremely important to inform future studies in this area.
- Conditions
- Inguinal Hernia, Groin Hernia, Surgery
- Keywords
- Inguinal, Hernia, Inguinal Hernia, Groin Hernia, Audit, Groin hernia management, mesh repair, non-mesh repair, laparoscopic repair, Global Surgery, Surgery
- Medical subject headings
- Hernia, Inguinal, 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 |
|---|---|---|
| Period 1 | 00:00 30th Jan 2023 - 23:59 26th Feb 2023 (+ 30 Day Follow-up) | |
| Period 2 | 00:00 27th Feb 2023 - 23:59 26th Mar 2023 (+ 30 Day Follow-up) | |
| Period 3 | 00:00 27th Mar 2023 - 23:59 23th Apr 2023 (+ 30 Day Follow-up) | |
| Period 4 | 00:00 24th April 2023 - 23:59 21st May 2023 (+ 30 Day Follow-up) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compliance to audit standards described
Mini-teams of up to five collaborators per data collection period will prospectively collect data on audit standards and confounding factors such as age, sex, BMI, ASA grade
Measured: A continuous 28-day period
Compliance to audit standards described
Mini-teams of up to five collaborators per data collection period will prospectively collect data on audit standards and confounding factors such as BMI
Measured: A continuous 28-day period
Compliance to audit standards described
Mini-teams of up to five collaborators per data collection period will prospectively collect data on audit standards and confounding factors such as ASA grade
Measured: A continuous 28-day period
Secondary outcomes (5)
Number of patients with a 30-day follow-up
Considering there is no standard practice regarding if patients are evaluated at 30 days after surgery, whether in person or by phone, we establish to characterise this variation globally. Analysing the number of patients who had a phone follow-up and number of patients who did not have any follow up
Measured: 30 days post surgery
30-day surgical site infection rates
Surgical site infection is defined at 30 days post-surgery using the Centers for Disease Control (CDC) definition of deep incisional or superficial incisional SSI
Measured: 30 days post surgery
30-day reoperation rates
Re-operation within 30-days of the index operation
Measured: 30 days post surgery
Number of patients re-admitted at 30-days
This will be related to postoperative complications that might require admission of patients and will be measured as number of patients readmitted at 30 days after surgery.
Measured: 30 days post surgery
Number of patients who had a complication at 30 days, measured by Clavien-Dindo classification.
Adverse post-operative events within the follow-up period (30 days)
Measured: 30 days post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2023
- Study start31 Jan 2023
- Primary completion21 Jun 2023 (estimated)
- Study completion15 Jul 2023 (estimated)
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 Inguinal 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
- Prospective
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05748886
- Sponsor's protocol ID
- HIPPO
- Acronym
- HIPPO
- Status last verified
- Feb 2023
- First submitted
- 8 Feb 2023
- Last updated
- 1 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
National Institute for Health and Care Research (NIHR) Global Health Research Unit on Global Surgery. Global access to technologies to support safe and effective inguinal hernia surgery: prospective, international cohort study. Br J Surg. 2024 Jul 2;111(7):znae164. doi: 10.1093/bjs/znae164. No abstract available.
PubMed 38985889
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Global Cohort Study: Hernias, Pathway and Planetary Outcomes for Inguinal Hernia Surgery
- ClinicalTrials.gov ID
- NCT05748886
- Acronym / sponsor ID
- HIPPO / HIPPO
- Conditions
- Inguinal Hernia, Groin Hernia, Surgery
- Keywords
- Inguinal, Hernia, Inguinal Hernia, Groin Hernia, Audit, Groin hernia management, mesh repair, non-mesh repair
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- University of BirminghamUniversity, hospital or other
- Study start
- 31 Jan 2023 (actual)
- Primary completion
- 21 Jun 2023 (estimated)
- Study completion
- 15 Jul 2023 (estimated)
- First posted
- 1 Mar 2023 (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.
The primary aim of the HIPPO study is to identify compliance to audit standards (pre-operative and intraoperative) standards for the repair and management of inguinal hernia.
A prospective, multicentre, cohort study will be delivered by NIHR Unit on Global Surgery globally. Mini-teams of up to five collaborators per data collection period will prospectively collect data over a continuous 28-day period at each participating centre. This will be on consecutive patients undergoing elective and/or emergency primary inguinal hernia surgery, with follow-up to 30 postoperative days.
Detailed description
Inguinal hernia surgery is one of the most common elective operations around the world. It was significantly down-prioritised during the pandemic, with fewer planned procedures and a likely increase in a global backlog. According to the most updated data, there are 74,822 patients waiting for inguinal hernia repair in the United Kingdom's National Health Service (NHS), although the recommended expected waiting time should not exceed 18 weeks. It is likely that other countries face the same problem, although such granular data does not exist. Additionally, while waiting for an elective repair, complications of inguinal hernia might arise and an emergency surgery might be needed. Identifying the scale of the global backlog at a global level will inform policy makers on the best strategies to optimise this elective surgical pathway.
Different surgical techniques exist, with different mesh and non-mesh techniques being described. The most up-to-date international guidelines recommend Lichenstein as the gold-standard for open repair of inguinal hernias, but a more tailored approach is recommended. The patient, the hernia type, and the surgeon's expertise will influence the choice of surgical technique which leads to a wide variation worldwide. Additionally, in areas where there is a deficit of surgeons, task sharing and task shifting might be implemented. Identification of this practice across the world and the outcomes associated with it will inform future research in this area.
Finally, as inguinal hernia repair is a very common procedure, it can reflect the global uptake of environmentally sustainable measures in elective surgery. Achieving a net zero health system is only possible if reducing the carbon output from operating theatres is included. Different countries might have different protocols and measures adopted to be environmentally sustainable that could be used in different settings. Understanding the baseline point of these practices is extremely important to inform future studies in this area.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Period 1 | – | –00:00 30th Jan 2023 - 23:59 26th Feb 2023 (+ 30 Day Follow-up) |
| Period 2 | – | –00:00 27th Feb 2023 - 23:59 26th Mar 2023 (+ 30 Day Follow-up) |
| Period 3 | – | –00:00 27th Mar 2023 - 23:59 23th Apr 2023 (+ 30 Day Follow-up) |
| Period 4 | – | –00:00 24th April 2023 - 23:59 21st May 2023 (+ 30 Day Follow-up) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Consecutive patients during the selected study period undergoing elective or emergency primary inguinal hernia repair through any operative approach.
Key inclusion criteria (5 listed)
- Summary: Consecutive patients during the selected study period undergoing elective or emergency primary inguinal hernia repair through any operative approach.
- Age: Paediatric and adult patients
- Procedure: Primary inguinal hernia repair, where this is the main procedure. For patients with bilateral inguinal hernias, data should be entered only for the larger of the two.
- Approach: Open groin incision, laparoscopic, laparoscopic assisted, laparoscopic converted, robotic, robotic converted procedures are all eligible. Patients with open incisions other than groin incision (e.g. laparotomy) are excluded.
- Urgency: Patients undergoing planned (elective) surgery or emergency surgery
Key exclusion criteria (14 listed)
- Recurrent inguinal hernias
- Surgeries where inguinal hernia repair is not the main procedure, but performed as an additional procedure (eg patient operated for colon cancer and undergoing inguinal hernia repair during the same operation).
- If patients are undergoing repair of two different types of hernia they can be included if the inguinal hernia repair is the main operation. (e.g. patient undergoing both inguinal and umbilical hernia repair). However, if the inguinal hernia repair is a secondary procedure to a larger non-inguinal hernia repair, patients should be excluded (e.g patient undergoing both large incisional hernia repair and inguinal hernia repair).
- Laparoscopic converted to open midline procedures
- Patients undergoing surgery with intent of repair of inguinal hernia, where no hernia inguinal hernia was identified (e.g. intra-operative findings of adenopathy, femoral hernia, obturator hernia)
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
Compliance to audit standards described
Time frame: A continuous 28-day period
Mini-teams of up to five collaborators per data collection period will prospectively collect data on audit standards and confounding factors such as age, sex, BMI, ASA grade
Compliance to audit standards described
Time frame: A continuous 28-day period
Mini-teams of up to five collaborators per data collection period will prospectively collect data on audit standards and confounding factors such as BMI
Compliance to audit standards described
Time frame: A continuous 28-day period
Mini-teams of up to five collaborators per data collection period will prospectively collect data on audit standards and confounding factors such as ASA grade
5 secondary outcomes
Number of patients with a 30-day follow-up
Time frame: 30 days post surgery
30-day surgical site infection rates
Time frame: 30 days post surgery
30-day reoperation rates
Time frame: 30 days post surgery
Number of patients re-admitted at 30-days
Time frame: 30 days post surgery
Number of patients who had a complication at 30 days, measured by Clavien-Dindo classification.
Time frame: 30 days post surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2023.
- Derived from this study: PubMed 38985889National Institute for Health and Care Research (NIHR) Global Health Research Unit on Global Surgery. Global access to technologies to support safe and effective inguinal hernia surgery: prospective, international cohort study. Br J Surg. 2024 Jul 2;111(7):znae164. doi: 10.1093/bjs/znae164. No abstract available.
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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.
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 Inguinal Hernia and Groin Hernia, run by University of Birmingham 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 5 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 1 Mar 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aneel Bhangu (+44 (0) 121 3718121, A.A.Bhangu@bham.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compliance to audit standards described (time frame: A continuous 28-day period). The study lists 3 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 NCT05748886, 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 1 Mar 2023.