RecruitingNot ApplicableNCT04699201

Trocar Site Incisional Hernia Prevention

Prevenció De L'Hèrnia Incisional Per Tròcar


Sponsor

Hospital Universitari Joan XXIII de Tarragona.

Enrollment

94 participants

Start Date

Mar 2, 2021

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 99 Years

Inclusion Criteria2

  • 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

Exclusion Criteria6

  • Allergy or intolerance to any of the mesh components
  • Patients presenting already primary or incisional hernia of the abdominal wall
  • ASA ≥IV
  • Intraoperative conversion to laparotomy
  • Emergency surgery
  • Pregnancy

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Interventions

PROCEDUREHincisional hernia prevention by onlay prosthesis trocar closure

Hincisional hernia prevention by onlay prosthesis trocar closure

PROCEDURElaparoscopic cholecystectomy

Laparoscopic cholecystectomy with or without common bile duct exploration

DIAGNOSTIC_TESTAbdominal 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

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NCT04699201


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