Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT04699201 |
| Other study ID # |
156/2020 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 2, 2021 |
| Est. completion date |
February 2024 |
Study information
| Verified date |
September 2023 |
| Source |
Hospital Universitari Joan XXIII de Tarragona. |
| Contact |
Joan Ferreres Serafini, MD |
| Phone |
(+34) 657920793 |
| Email |
joanfs8[@]gmail.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
