Corona Mortis in Patients Undergoing TEP for Inguinal Hernia

Sponsor
Sofia Med Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT04303442
Collaborator
(none)
300
1
17
17.7

Study Details

Study Description

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 Phase
  • 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.

Study Design

Study Type:
Observational
Actual 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 :
Jan 2, 2020
Actual Primary Completion Date :
May 25, 2021
Actual Study Completion Date :
Jun 1, 2021

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. Presence of CMOR [Intraoperative]

    Evaluation of presence of Corona mortis in each hemipelvis examined. For unilateral hernias - one hemipelvis, in bilateral - two hemipelvices.

  2. Type CMOR [Intraoperative]

    Evaluation of the type of Corona Mortis - Arterial, Venous or both types, in each hemipelvis

  3. Size of CMOR [Intraoperative]

    Evaluation of size of Corona Mortis in mm., measured with ruler.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 90 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Sofiamed Hospital Sofia Bulgaria

Sponsors and Collaborators

  • Sofia Med Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Sofia Med Hospital
ClinicalTrials.gov Identifier:
NCT04303442
Other Study ID Numbers:
  • 207
First Posted:
Mar 11, 2020
Last Update Posted:
Jun 21, 2021
Last Verified:
Jun 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Sofia Med Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 21, 2021