Actively Recruiting
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
Eligibility Criteria
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
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
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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
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
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