Corona Mortis in Patients Undergoing TEP for Inguinal Hernia

A Prospective Endoscopic Study of the Presence, Type and Size of Corona Mortis in 300 Patients Undergoing Total Extraperitoneal (TEP) Inguinal Hernia Repair Procedures

This study aim to describe the presence, type and size of Corona mortis (CMOR) in patients undergoing total extraperitoneal (TEP) inguinal hernia repair procedures. This study also aim to describe the preperitoneal vascular anatomy of inguinal area and provide in vivo knowledge about CMOR.

Study Overview

• Status: Completed
• Conditions: Inguinal Hernia; Bleeding; Pelvic Fracture; Acetabular Fracture
• Intervention / Treatment: Procedure: TEP

Detailed Description

Corona mortis is classically defined as the arterial and/or venous vascular anastomosis between the obturator artery and external iliac artery (most commonly the inferior epigastric artery) that crosses the posterior aspect of the superior ramus of the symphysis pubis. It runs along the posterior aspect of the superior pubic ramus and its laceration can prove life threatening in trauma cases or in scheduled operations.

CMOR is clinically important due to the potential risk of bleeding in pelvic fractures, pelvic and acetabular operations, surgery for urinary incontinence, oncologycal pelvic dissections and laparoscopic hernia repair. It requires special interests from different surgical branches, such as orthopedics, oncologic surgery, urogynecology and general surgery. Vascular anatomy of retropubic area, especially CMOR, should be kept in mind by surgeons performing laparoscopic surgery for hernia repair. In literature, the anatomical data have usually been come from studies performed on cadavers. The aim of this study was to provide in vivo knowledge about the presence, type (venous and/or arterial) and size of CMOR in patients who underwent TEP repair.

300 patients will undergo TEP procedure for unilateral or bilateral inguinal hernias. TEP procedures will be performed with three ports and one or three skin incisions. The presence and type of CMOR will be evaluated, and picture will be made. The size of the CMOR will be defined with ruler inserted true the 10 mm port.

• Study Type: Observational
• Enrollment (Actual): 300

Contacts and Locations

Study Locations

• Bulgaria
  • Sofia, Bulgaria
    • Sofiamed Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 88 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients male and female, undergoing TEP inguinal hernia repair.

Description

Inclusion Criteria:

• Diagnosed primary or recurrence unilateral or bilateral inguinal hernia
• Age between 18 and 90;

Exclusion Criteria:

• Patients who prefer other surgical approach than TEP

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients undergoing TEP; Patients diagnosed with unilateral or bilateral primary and/or recurrence inguinal hernia undergoing Total Extraperitoneal laparoscopic hernia repair.	Procedure: TEP; Total extraperitoneal laparoendoscopic hernia repair with one or three skin incisions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Presence of CMOR	Evaluation of presence of Corona mortis in each hemipelvis examined. For unilateral hernias - one hemipelvis, in bilateral - two hemipelvices.	Intraoperative
Type CMOR	Evaluation of the type of Corona Mortis - Arterial, Venous or both types, in each hemipelvis	Intraoperative
Size of CMOR	Evaluation of size of Corona Mortis in mm., measured with ruler.	Intraoperative

Collaborators and Investigators

• Sponsor: Sofia Med Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2020
• Primary Completion (Actual): May 25, 2021
• Study Completion (Actual): June 1, 2021

Study Registration Dates

• First Submitted: March 8, 2020
• First Submitted That Met QC Criteria: March 10, 2020
• First Posted (Actual): March 11, 2020

Study Record Updates

• Last Update Posted (Actual): June 21, 2021
• Last Update Submitted That Met QC Criteria: June 18, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: TEP; Bleeding; Anatomy; Laparoscopic Surgery; Inguinal Hernia; Corona Mortis; Inguinal region anatomy
• Additional Relevant MeSH Terms: Pathologic Processes; Wounds and Injuries; Leg Injuries; Pathological Conditions, Anatomical; Hernia, Abdominal; Femoral Fractures; Hip Injuries; Hernia; Hernia, Inguinal; Hemorrhage; Fractures, Bone; Hip Fractures
• Other Study ID Numbers: 207

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No