Corona Mortis in Patients Undergoing TEP for Inguinal Hernia

Bleeding Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04303442
• Other study ID #: 207
• Status: Completed
• Start date: January 2, 2020
• Est. completion date: June 1, 2021

Study information

• Verified date: June 2021
• Source: Sofia Med Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: June 1, 2021
• Est. primary completion date: May 25, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Acetabular Fracture
• Bleeding
• Fractures, Bone
• Hemorrhage
• Hernia
• Hernia, Inguinal
• Hip Fractures
• Inguinal Hernia
• Pelvic Fracture

Intervention

Procedure:
• TEP
Total extraperitoneal laparoendoscopic hernia repair with one or three skin incisions.

Locations

Country	Name	City	State
Bulgaria	Sofiamed Hospital	Sofia

Sponsors (1)

Lead Sponsor	Collaborator
Sofia Med Hospital

Country where clinical trial is conducted

Bulgaria, 

Outcome

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