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Trocar Site Incisional Hernia Prevention

RecruitingNAAges 18 Years - 99 YearsAllHospital Universitari Joan XXIII de Tarragona.
NCT04699201 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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 Criteria: * 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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What it tests

  • Hincisional hernia prevention by onlay prosthesis trocar closure
  • laparoscopic cholecystectomy
  • Abdominal ultrasound
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Where

2 sites
Hospital Universitari de Tarragona Joan XXIII
Tarragona, Spain
Pius, Hospital de Valls
Valls, Spain
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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