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RECRUITING
NCT04699201
NA

Trocar Site Incisional Hernia Prevention

Sponsor: Hospital Universitari Joan XXIII de Tarragona.

View on ClinicalTrials.gov

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

Interventions

PROCEDURE

Hincisional hernia prevention by onlay prosthesis trocar closure

Hincisional hernia prevention by onlay prosthesis trocar closure

PROCEDURE

laparoscopic cholecystectomy

Laparoscopic cholecystectomy with or without common bile duct exploration

DIAGNOSTIC_TEST

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