A Global Prospective Study on Inguinal Hernia Surgery

NCT05748886 | Unknown

• 1 other identifier: HIPPO
• Study Type: observational
• Target: 5,000
• Locations: 1 country
• Sites: 1

Brief 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. 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.

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (5)

• Number of patients with a 30-day follow-up

  30 days post surgery

• 30-day surgical site infection rates

  30 days post surgery

• 30-day reoperation rates

  30 days post surgery

• Number of patients re-admitted at 30-days

  30 days post surgery

• Number of patients who had a complication at 30 days, measured by Clavien-Dindo classification.

  30 days post surgery

Study Arms (4)

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)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Birmingham: lead

Study Sites (1)

University of Birmingham

Birmingham, United Kingdom

RECRUITING

MeSH Terms

Conditions

Hernia, Inguinal; Hernia

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Aneel Bhangu

CONTACT

+44 (0) 121 3718121; A.A.Bhangu@bham.ac.uk

Maria Picciochi

CONTACT

+44 (0) 121 3718121; maria.picciochi@gmail.com

Study Design

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

Study Record Dates

• First Submitted: February 8, 2023
• First Posted: March 1, 2023
• Study Start: January 31, 2023
• Primary Completion: June 21, 2023
• Study Completion: July 15, 2023
• Last Updated: March 1, 2023

Record last verified: 2023-02

Locations

GB (1)