Inguinal HerniaNCT04303442
Corona Mortis in Patients Undergoing TEP for Inguinal Hernia
An observational study of Inguinal Hernia and Pelvic Fracture, run by Sofia Med Hospital at 1 site in Bulgaria.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Inguinal Hernia, Pelvic Fracture, Acetabular Fracture
- What is being tested?
- TEP
- Type of treatment
- Surgery or procedure
- How many people
- 300 participants
- Where
- 1 siteBulgaria
- Study dates
- 2 Jan 2020to 1 Jun 2021
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients male and female, undergoing TEP inguinal hernia repair.
Who may be able to join
- Diagnosed primary or recurrence unilateral or bilateral inguinal hernia
- Age between 18 and 90;
Who cannot join
- Patients who prefer other surgical approach than TEP
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Inguinal Hernia, Pelvic Fracture, Acetabular Fracture, Bleeding
- Being tested
- TEP
- Keywords
- Corona Mortis, TEP, Inguinal Hernia, Laparoscopic Surgery, Anatomy, Inguinal region anatomy, Bleeding
- Medical subject headings
- Hernia, Inguinal, Hip Fractures, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TEPProcedure or surgery
Total extraperitoneal laparoendoscopic hernia repair with one or three skin incisions.
| Study group | Role | What they receive |
|---|---|---|
| Patients undergoing TEP | Patients diagnosed with unilateral or bilateral primary and/or recurrence inguinal hernia undergoing Total Extraperitoneal laparoscopic hernia repair. Receives: Procedure: TEP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of CMOR
Evaluation of presence of Corona mortis in each hemipelvis examined. For unilateral hernias - one hemipelvis, in bilateral - two hemipelvices.
Measured: Intraoperative
Type CMOR
Evaluation of the type of Corona Mortis - Arterial, Venous or both types, in each hemipelvis
Measured: Intraoperative
Size of CMOR
Evaluation of size of Corona Mortis in mm., measured with ruler.
Measured: Intraoperative
Diameter of Corona Mortis Vessels
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.
Measured: Intraoperatively, during retropubic dissection in the TEP procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2020
- Study start2 Jan 2020
- Primary completion25 May 2021
- Study completion1 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Inguinal HerniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sofia Med Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04303442
- Sponsor's protocol ID
- 207
- Status last verified
- Jul 2026
- First submitted
- 8 Mar 2020
- Last updated
- 20 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No