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Trocar Site Incisional Hernia Prevention
Sponsor: Hospital Universitari Joan XXIII de Tarragona.
Summary
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.
Official title: Prevenció De L'Hèrnia Incisional Per Tròcar
Key Details
Gender
All
Age Range
18 Years - 99 Years
Study Type
INTERVENTIONAL
Enrollment
94
Start Date
2021-03-02
Completion Date
2025-02
Last Updated
2024-10-02
Healthy Volunteers
Yes
Conditions
Interventions
Hincisional hernia prevention by onlay prosthesis trocar closure
Hincisional hernia prevention by onlay prosthesis trocar closure
laparoscopic cholecystectomy
Laparoscopic cholecystectomy with or without common bile duct exploration
Abdominal ultrasound
Ultrasound focused in abdominal wall defects on the trocar incisions, 12 months after the surgery
Locations (2)
Hospital Universitari de Tarragona Joan XXIII
Tarragona, Tarragona, Spain
Pius, Hospital de Valls
Valls, Tarragona, Spain