A Global Prospective Study on Inguinal Hernia Surgery (HIPPO)

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.

Study Overview

• Status: Recruiting
• Conditions: Inguinal Hernia; Surgery; Groin Hernia

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 Type: Observational
• Enrollment (Anticipated): 5000

Contacts and Locations

• Study Contact: Name: Aneel Bhangu; Phone Number: +44 (0) 121 3718121; Email: A.A.Bhangu@bham.ac.uk
• Study Contact Backup: Name: Maria Picciochi; Phone Number: +44 (0) 121 3718121; Email: maria.picciochi@gmail.com

Study Locations

• United Kingdom
  • Birmingham, United Kingdom
    • Recruiting
    • University of Birmingham
    • Contact: Maria Picciochi; Phone Number: + 44 (0) 121 378121; Email: maria.picciochi@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Consecutive patients during the selected study period undergoing elective or emergency primary inguinal hernia repair through any operative approach.

Description

Inclusion Criteria:

Summary: Consecutive patients during the selected study period undergoing elective or emergency primary inguinal hernia repair through any operative approach.

Inclusion criteria:

• 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

Exclusion Criteria:

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)

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).

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	A continuous 28-day period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	30 days post surgery
30-day reoperation rates	Re-operation within 30-days of the index operation	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.	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)	30 days post surgery

Collaborators and Investigators

• Sponsor: University of Birmingham

Study record dates

Study Major Dates

• Study Start (Actual): January 31, 2023
• Primary Completion (Anticipated): June 21, 2023
• Study Completion (Anticipated): July 15, 2023

Study Registration Dates

• First Submitted: February 8, 2023
• First Submitted That Met QC Criteria: February 17, 2023
• First Posted (Actual): March 1, 2023

Study Record Updates

• Last Update Posted (Actual): March 1, 2023
• Last Update Submitted That Met QC Criteria: February 17, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Surgery; mesh repair; Hernia; Inguinal Hernia; Inguinal; laparoscopic repair; Groin Hernia; Audit; Groin hernia management; non-mesh repair; Global Surgery
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hernia, Abdominal; Hernia; Hernia, Inguinal
• Other Study ID Numbers: HIPPO