NCT04303442

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 2, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 8, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 11, 2020

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 25, 2021

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2021

Completed
Last Updated

June 21, 2021

Status Verified

June 1, 2021

Enrollment Period

1.4 years

First QC Date

March 8, 2020

Last Update Submit

June 18, 2021

Conditions

Inguinal HerniaPelvic FractureAcetabular FractureBleeding

Keywords

Corona MortisTEPInguinal HerniaLaparoscopic SurgeryAnatomyInguinal region anatomyBleeding

Outcome Measures

Primary Outcomes (3)

  • Presence of CMOR

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

    Intraoperative

  • Type CMOR

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

    Intraoperative

  • Size of CMOR

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

    Intraoperative

Study Arms (1)

Patients undergoing TEP

Patients diagnosed with unilateral or bilateral primary and/or recurrence inguinal hernia undergoing Total Extraperitoneal laparoscopic hernia repair.

Procedure: TEP

Interventions

TEPPROCEDURE

Total extraperitoneal laparoendoscopic hernia repair with one or three skin incisions.

Patients undergoing TEP

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients male and female, undergoing TEP inguinal hernia repair.

You may qualify if:

  • Diagnosed primary or recurrence unilateral or bilateral inguinal hernia
  • Age between 18 and 90;

You may not qualify if:

  • Patients who prefer other surgical approach than TEP

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sofiamed Hospital

Sofia, Bulgaria

Location

MeSH Terms

Conditions

Hernia, InguinalHip FracturesHemorrhage

Interventions

tetraethylpyrazine

Condition Hierarchy (Ancestors)

Hernia, AbdominalHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsFemoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg InjuriesPathologic Processes

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 8, 2020

First Posted

March 11, 2020

Study Start

January 2, 2020

Primary Completion

May 25, 2021

Study Completion

June 1, 2021

Last Updated

June 21, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations

BU(1)