Actively Recruiting

Phase Not Applicable
Age: 18Years - 99Years
All Genders
Healthy Volunteers
NCT04699201

Trocar Site Incisional Hernia Prevention

Led by Hospital Universitari Joan XXIII de Tarragona. · Updated on 2024-10-02

94

Participants Needed

2

Research Sites

204 weeks

Total Duration

On this page

Sponsors

H

Hospital Universitari Joan XXIII de Tarragona.

Lead Sponsor

I

Institut de Diagnostic per la Imatge

Collaborating Sponsor

AI-Summary

What this Trial Is About

Objective: To test the preventive effect of the placement of an onlay mesh versus the use of a fascial closure device at the umbilical trocar site closure in order to prevent incisional hernia after laparoscopic surgery. Methods: We designed a Two Center Randomized Controlled Trial were adult participants presenting for elective laparoscopic cholecystectomy, with or without an exploration of the common bile duct will be recruited, with allocation of each of them in 2 groups (prosthesis and control). Abdominal ultrasound scan focused on aponeurosis defects at the trocar sites will be performed at 12 postoperative months. An ultrasound scan will be performed to avoid underdiagnosis bias since incisional hernia is frequently under detected by clinical examination. Relevance: The prevalence of incisional hernia after laparoscopy might be as high as 30%, due to this reason is paramount to find a better closure technique. There are few studies about incisional hernia including radiological exams in order to provide the exact prevalence of this pathology, even fewer literature exists about incisional hernia after laparoscopic procedures.

CONDITIONS

Official Title

Trocar Site Incisional Hernia Prevention

Who Can Participate

Age: 18Years - 99Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients undergoing elective laparoscopic cholecystectomy, with or without exploration of the common bile duct, at the study hospital
  • ASA (American Society of Anesthesiologists) classification less than IV
Not Eligible

You will not qualify if you...

  • Allergy or intolerance to any component of the mesh
  • Existing primary or incisional hernia of the abdominal wall
  • ASA classification IV or higher
  • Intraoperative conversion to open surgery (laparotomy)
  • Emergency surgery
  • Pregnancy

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 2 locations

1

Hospital Universitari de Tarragona Joan XXIII

Tarragona, Tarragona, Spain, 43005

Actively Recruiting

2

Pius, Hospital de Valls

Valls, Tarragona, Spain, 43800

Actively Recruiting

Loading map...

Research Team

J

Joan Ferreres Serafini, MD

CONTACT

R

Rosa Jorba Martin, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here