Trocar Site Incisional Hernia Prevention (PHIT)

Prevenció de l'Hèrnia Incisional Per Tròcar

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.

Study Overview

• Status: Recruiting
• Conditions: Incisional Hernia
• Intervention / Treatment: Procedure: Hincisional hernia prevention by onlay prosthesis trocar closure; Procedure: laparoscopic cholecystectomy; Diagnostic test: Abdominal ultrasound

Detailed Description

OBJECTIVE To test the preventive effect of the placement of an onlay mesh at the time of umbilical trocar site closure in order to prevent incisional hernia after laparoscopic surgery.

The estimated prevalence of incisional hernia after laparoscopy is 15- 25%, being even higher among patients with risk factors. Many different closure techniques exist, however few of them have been tested in Randomised Control Trials. Most of them lack an image technique to provide more accurate results.

METHODOLOGY

We designed a Two Center, Randomized Controlled Trial that will enroll patients undergoing laparoscopic cholecystectomy, with or without an exploration of the common bile duct. Participants will be randomized to 2 groups. The pneumoperitoneum technique will be achieved by Hasson technique. The closure procedure will take place at the end of the surgery, after the cholecystectomy is performed:

• Prosthesis: after suturing the aponeurosis with a J needle and 0 Polydioxanone, a lightweight, large-pore mesh made of PVDF monofilament (polyvinylidene fluoride - DynaMesh-CICAT, FEC Textiltechnik, Germany) will be placed onlay, overlapping 2cm in all directions from the edge of the aponeurosis incision at the umbilical trocar site. The mesh will be fixed to the aponeurosis with cyanoacrylate glue (Glubran®, GEM, Viareggio, Italy).
• Control: Closure of the aponeurosis will be performed by standard procedure: under direct vision, suturing the aponeurosis with a J needle and 0 Polydioxanone, with a stitch interval of ≤ 5mm.

An abdominal ultrasound scan focused on aponeurosis defects at the trocar sites will be performed at 12 postoperative months. Minimum follow-up will be 12 months.

All the adverse events will be registered and classified according to the Clavien Dindo classification.

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.

Univariate descriptive analysis will present the results as means (with standard deviation and range) for the continuous variables and as numbers and percentages for the categorical variables. Bivariate analysis will be carried out among the variables of interest to describe their level of correlation and evaluate the possible differences between them. To evaluate the differences between the continuous variables we will use the comparison of means based on the T-Student and for the comparison of categorical variables the Chi-square test. Finally, linear regression models and generalized linear models (as appropriate depending on the response variable) will be used to study the dependence of the variables of interest, with other factors of study. Statistical analysis will be carried out using the SPSS (Statistical Package for the Social Sciences) Software (IBM SPSS Statistics 23). All tests will be bilateral with a level of significance of 5%. 100% of the data recorded will be analyzed, and the proportion of values lost in the variables of interest will be evaluated.

• Study Type: Interventional
• Enrollment (Estimated): 94
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Joan Ferreres Serafini, MD; Phone Number: (+34) 657920793; Email: joanfs8@gmail.com
• Study Contact Backup: Name: Rosa Jorba Martin, MD; Email: rjorba.hj23.ics@gencat.cat

Study Locations

• Spain
  • Tarragona, Spain, 43005
    • Recruiting
    • Hospital Universitari de Tarragona Joan XXIII
    • Contact: Joan Ferreres Serafini, MD; Phone Number: 657920793; Email: joanfs8@gmail.com
  • Tarragona
    • Valls, Tarragona, Spain, 43800
      • Recruiting
      • Pius, Hospital de Valls
      • Contact: Joan Ferreres Serafini, MD; Phone Number: 657920793; Email: joanfs8@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Prosthesis; Firstly, a laparoscopic cholecystectomy is performed. After suturing the aponeurosis with a J needle and 0 Polydioxanone, a lightweight, large-pore mesh made of PVDF monofilament (polyvinylidene fluoride - DynaMesh-CICAT, FEC Textiltechnik, Germany) will be placed onlay, overlapping 2cm in all directions from the edge of the aponeurosis incision at the umbilical trocar site. The mesh will be fixed to the aponeurosis with cyanoacrylate glue (Glubran®, GEM, Viareggio, Italy).	Procedure: Hincisional hernia prevention by onlay prosthesis trocar closure; Hincisional hernia prevention by onlay prosthesis trocar closure; Procedure: laparoscopic cholecystectomy; Laparoscopic cholecystectomy with or without common bile duct exploration; Diagnostic test: Abdominal ultrasound; Ultrasound focused in abdominal wall defects on the trocar incisions, 12 months after the surgery
Active Comparator: Control; Firstly, a laparoscopic cholecystectomy is performed. Closure of the aponeurosis will be performed by standard procedure: under direct vision, suturing the aponeurosis with a J needle and 0 Polydioxanone, with a stitch interval of ≤ 5mm.	Procedure: laparoscopic cholecystectomy; Laparoscopic cholecystectomy with or without common bile duct exploration; Diagnostic test: Abdominal ultrasound; Ultrasound focused in abdominal wall defects on the trocar incisions, 12 months after the surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perioperative complications	Secondary endpoints will be perioperative complications, including wound infection, haematoma, pain and reoperation.	30 days
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.	12 months

Collaborators and Investigators

• Sponsor: Hospital Universitari Joan XXIII de Tarragona.
• Collaborators: Institut Investigacio Sanitaria Pere Virgili; Institut de Diagnòstic per la Imatge (IDI)
• Investigators: Study Director: Carles Olona Casas, MD, Hospital Universitari de Tarragona

Study record dates

Study Major Dates

• Study Start (Actual): March 2, 2021
• Primary Completion (Estimated): November 1, 2023
• Study Completion (Estimated): February 1, 2024

Study Registration Dates

• First Submitted: January 6, 2021
• First Submitted That Met QC Criteria: January 6, 2021
• First Posted (Actual): January 7, 2021

Study Record Updates

• Last Update Posted (Actual): September 26, 2023
• Last Update Submitted That Met QC Criteria: September 23, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Incisional Hernia, Umbilical Trocar, Preventive mesh
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pathological Conditions, Anatomical; Hernia; Incisional Hernia
• Other Study ID Numbers: 156/2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No