Prevenció De L'Hèrnia Incisional Per Tròcar

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Procedure, Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 99
Healthy Volunteers: t
View:

• Patients undergoing elective laparoscopic cholecystectomy, with or without an exploration of the common bile duct, undergoing surgery in our hospital

• ASA (American Society of Anesthesiologists) \<IV

Locations
Other Locations
Spain
Hospital Universitari de Tarragona Joan XXIII
RECRUITING
Tarragona
Pius, Hospital de Valls
RECRUITING
Valls
Contact Information
Primary
Joan Ferreres Serafini, MD
joanfs8@gmail.com
(+34) 657920793
Backup
Rosa Jorba Martin, MD
rjorba.hj23.ics@gencat.cat
Time Frame
Start Date: 2021-03-02
Estimated Completion Date: 2025-02
Participants
Target number of participants: 94
Treatments
Experimental: Prosthesis
Firstly, a laparoscopic cholecystectomy is performed. After suturing the aponeurosis with a J needle and 0 Polydioxanone, a lightweight, large-pore mesh made of PVDF monofilament (polyvinylidene fluoride - DynaMesh-CICAT, FEC Textiltechnik, Germany) will be placed onlay, overlapping 2cm in all directions from the edge of the aponeurosis incision at the umbilical trocar site. The mesh will be fixed to the aponeurosis with cyanoacrylate glue (Glubran®, GEM, Viareggio, Italy).
Active_comparator: Control
Firstly, a laparoscopic cholecystectomy is performed. Closure of the aponeurosis will be performed by standard procedure: under direct vision, suturing the aponeurosis with a J needle and 0 Polydioxanone, with a stitch interval of ≤ 5mm.
Related Therapeutic Areas
Sponsors
Collaborators: Institut de Diagnostic per la Imatge, Institut Investigacio Sanitaria Pere Virgili
Leads: Hospital Universitari Joan XXIII de Tarragona.

This content was sourced from clinicaltrials.gov

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