Clinical trial NCT04303442: Corona Mortis in Patients Undergoing TEP for Inguinal Hernia
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Inguinal Hernia
Pelvic Fracture
Acetabular Fracture
Bleeding
Keywords: Corona Mortis
TEP
Inguinal Hernia
Laparoscopic Surgery
Anatomy
Inguinal region anatomy
Bleeding
Lead sponsor: Sofia Med Hospital
Sponsor class: OTHER
First posted: 2020-03-11
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients male and female, undergoing TEP inguinal hernia repair.

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Presence of CMOR
timeFrame: Intraoperative
measure: Type CMOR
timeFrame: Intraoperative
measure: Size of CMOR
timeFrame: Intraoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Sofia
country: Bulgaria
facility: Sofiamed Hospital
Study officials:
References: