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Trocar Site Incisional Hernia Prevention

ConditionIncisional Hernia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-99
SponsorHospital Universitari Joan XXIII de Tarragona.

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Hincisional hernia prevention by onlay prosthesis trocar closure

    Procedure/Surgery

    Hincisional hernia prevention by onlay prosthesis trocar closure

  • laparoscopic cholecystectomy

    Procedure/Surgery

    Laparoscopic cholecystectomy with or without common bile duct exploration

  • Abdominal ultrasound

    Diagnostic test

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

Treatment groups

94 Participants
are divided into 2 treatment groups
Group A: ProsthesisExperimental treatment 3 interventions
Group B: ControlActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Incidence of incisional hernia

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).

Time frame
12 months

Secondary outcomes

1

Perioperative complications

Secondary endpoints will be perioperative complications, including wound infection, haematoma, pain and reoperation.

Time frame
30 days
2

Economical impact

We will compare on one side the cost of the mesh and the glue and on the other side the costs of reoperation and hospital stay in case of appearance of incisional hernias.

Time frame
12 months

Other outcomes

Sponsors and contacts

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Hospital Universitari Joan XXIII de Tarragona.

Lead sponsor

Institut de Diagnostic per la Imatge

Collaborator

Institut Investigacio Sanitaria Pere Virgili

Collaborator

Source ClinicalTrials.gov
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