Trocar Site Incisional Hernia Prevention
Recruiting now · Not applicable
Conditions studied: Incisional Hernia
In brief
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.
Key facts
- Study ID
- NCT04699201
- Run by
- Hospital Universitari Joan XXIII de Tarragona.
- People needed
- 94
- Starts
- 2021-03-02
- Expected to finish
- 2025-02-01
- Last updated by the study team
- 2024-10-02
Who can join
Age: 18 and older, up to 99. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Hospital Universitari de Tarragona Joan XXIII — Tarragona, Tarragona, Spain (enrolling)
- Pius, Hospital de Valls — Valls, Tarragona, Spain (enrolling)
Full record on ClinicalTrials.gov
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