Trocar Site Incisional Hernia Prevention

Condition(s) studied

Investigational drug(s) / intervention(s)

Hincisional hernia prevention by onlay prosthesis trocar closure: Hincisional hernia prevention by onlay prosthesis trocar closure

laparoscopic cholecystectomy: Laparoscopic cholecystectomy with or without common bile duct exploration

Abdominal ultrasound: Ultrasound focused in abdominal wall defects on the trocar incisions, 12 months after the surgery

Study 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

Primary outcome measure(s)

• Incidence of incisional hernia — 12 months
  The primary endpoint is the incidence of incisional hernia in the 2 groups. Because incisional hernia may occur within the first months after surgery, assessment will be carried out during scheduled clinical visits over 12 months. The presence of incisional hernia will be evaluated by physical examination and radiologically by an abdominal US scan performed at the end of follow-up (12 months after operation).

Trial sites (2)

Other trials for the same condition