Corona Mortis in Patients Undergoing TEP for Inguinal Hernia

NCT04303442 — Completed, 300 participants, Sofia Med Hospital

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

RegistryNCT04303442
StatusCompleted
Study typeObservational
Enrollment300 (Actual)
SponsorSofia Med Hospital (Other)
ConditionsInguinal Hernia, Pelvic Fracture, Acetabular Fracture, Bleeding
InterventionsTEP (Procedure)
Datesstart 2020-01-02, primary completion 2021-05-25, completion 2021-06-01, first posted 2020-03-11, last updated 2026-10-20
Locations1 site in Bulgaria

Related Papers Related Patents Related Grants Related Experts
All trials for Inguinal Hernia All trials for Pelvic Fracture All trials of TEP

-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.

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
Patients undergoing TEPProcedure: TEPPatients diagnosed with unilateral or bilateral primary and/or recurrence inguinal hernia undergoing Total Extraperitoneal laparoscopic hernia repair.
  • TEP (Procedure): Total extraperitoneal laparoendoscopic hernia repair with one or three skin incisions.

+Outcome measures

Primary outcomes

  • Presence of CMOR [Intraoperative]: Evaluation of presence of Corona mortis in each hemipelvis examined. For unilateral hernias - one hemipelvis, in bilateral - two hemipelvices.
  • Type CMOR [Intraoperative]: Evaluation of the type of Corona Mortis - Arterial, Venous or both types, in each hemipelvis
  • Size of CMOR [Intraoperative]: Evaluation of size of Corona Mortis in mm., measured with ruler.
  • Diameter of Corona Mortis Vessels [Intraoperatively, during retropubic dissection in the TEP procedure]: The diameter of each identified arterial and/or venous corona mortis vessel was measured intraoperatively in millimeters using a sterile ruler introduced through a 10-mm trocar. When more than one vessel was identified in the same hemipelvis, each vessel was measured and analyzed separately.

+Eligibility

Sex: All, ages: 18 Years to 90 Years

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

+Posted results

Participant flow

MilestonePatients Undergoing TEP
Started300
Completed300
Not completed0

Outcome results

  • Presence of CMOR (Primary), Number, Hemipelves: Patients Undergoing TEP 229
  • Type CMOR (Primary), Count of units, Hemipelves: Patients Undergoing TEP 28
  • Size of CMOR (Primary), Count of units, Number or vessels: Patients Undergoing TEP 182
  • Diameter of Corona Mortis Vessels (Primary), Mean, mm: Patients Undergoing TEP 2.42 +/- 1.44

Adverse events

Time frame: From the start to the end of the TEP procedure (intraoperative period only).

ArmDeathsSerious adverse eventsOther adverse events
Patients Undergoing TEP0/300 (0.0%)0/300 (0.0%)0/300 (0.0%)

+Locations (1)

FacilityCityCountryStatus
Sofiamed HospitalSofiaBulgaria

+Study documents