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Corona Mortis in Patients Undergoing TEP for Inguinal Hernia

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ClinicalTrials.gov Identifier: NCT04303442
Recruitment Status : Recruiting
First Posted : March 11, 2020
Last Update Posted : March 11, 2020
Sponsor:
Information provided by (Responsible Party):
Sofia Med Hospital

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.

Condition or disease Intervention/treatment
Inguinal Hernia Pelvic Fracture Acetabular Fracture Bleeding 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.

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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Case-Only
Time Perspective: Prospective
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
Actual Study Start Date : January 2, 2020
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : March 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia

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.




Primary Outcome Measures :
  1. Presence of CMOR [ Time Frame: Intraoperative ]
    Evaluation of presence of Corona mortis in each hemipelvis examined. For unilateral hernias - one hemipelvis, in bilateral - two hemipelvices.

  2. Type CMOR [ Time Frame: Intraoperative ]
    Evaluation of the type of Corona Mortis - Arterial, Venous or both types, in each hemipelvis

  3. Size of CMOR [ Time Frame: Intraoperative ]
    Evaluation of size of Corona Mortis in mm., measured with ruler.



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients male and female, undergoing TEP inguinal hernia repair.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04303442


Locations
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Bulgaria
Sofiamed Hospital Recruiting
Sofia, Bulgaria
Contact: Teodor Atanasov, Ass. proff.    +359899802612    teodor.atanassov@gmail.com   
Contact: Katya Todorova, MD    +359884744833    katya.todorowa@gmail.com   
Principal Investigator: Alexander Tsvetanov, MD         
Sponsors and Collaborators
Sofia Med Hospital
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Responsible Party: Sofia Med Hospital
ClinicalTrials.gov Identifier: NCT04303442    
Other Study ID Numbers: 207
First Posted: March 11, 2020    Key Record Dates
Last Update Posted: March 11, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sofia Med Hospital:
Corona Mortis
TEP
Inguinal Hernia
Laparoscopic Surgery
Anatomy
Inguinal region anatomy
Bleeding
Additional relevant MeSH terms:
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Hemorrhage
Hernia
Hernia, Inguinal
Fractures, Bone
Hip Fractures
Wounds and Injuries
Pathologic Processes
Pathological Conditions, Anatomical
Hernia, Abdominal
Femoral Fractures
Hip Injuries
Leg Injuries