Recruiting NA Incisional Hernia

Prevention study for Incisional Hernia

Official title Trocar Site Incisional Hernia Prevention

ClinicalTrials.gov ID: NCT04699201

What this study is testing

What it's testing
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).
  • Which group you join is decided by chance.

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 to 99. Healthy volunteers may be eligible.

You may be able to join 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 likely can't join 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

The study team makes the final eligibility decision.

Where it's taking place

  • Tarragona, Tarragona, Spain
  • Valls, Tarragona, Spain

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18 years to 99 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Tarragona, Tarragona, Spain; Valls, Tarragona, Spain. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.