Incisional HerniaPHITNCT04699201
Trocar Site Incisional Hernia Prevention
A study testing Hincisional hernia prevention by onlay prosthesis trocar closure, laparoscopic cholecystectomy and Abdominal ultrasound in people with Incisional Hernia, run by Hospital Universitari Joan XXIII de Tarragona. at 2 sites in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Incisional Hernia
- What is being tested?
- Hincisional hernia prevention by onlay prosthesis trocar closure, laparoscopic cholecystectomy and Abdominal ultrasound
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 2 sitesSpain
- Study dates
- 2 Mar 2021to Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Rosa Jorba Martin, MD contact
Spain2 sites, 2 recruiting
- Recruiting
Hospital Universitari de Tarragona Joan XXIII
Tarragona, Tarragona, 43005
Joan Ferreres Serafini, MD, 657920793, joanfs8@gmail.com
- Recruiting
Pius, Hospital de Valls
Valls, Tarragona, 43800
Joan Ferreres Serafini, MD, 657920793, joanfs8@gmail.com
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Incisional Hernia
- Being tested
- Hincisional hernia prevention by onlay prosthesis trocar closure, laparoscopic cholecystectomy, Abdominal ultrasound
- Keywords
- Incisional Hernia, Umbilical Trocar, Preventive mesh
- Medical subject headings
- Incisional Hernia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hincisional hernia prevention by onlay prosthesis trocar closureProcedure or surgery
Hincisional hernia prevention by onlay prosthesis trocar closure
laparoscopic cholecystectomyProcedure or surgery
Laparoscopic cholecystectomy with or without common bile duct exploration
Abdominal ultrasoundDiagnostic test
Ultrasound focused in abdominal wall defects on the trocar incisions, 12 months after the surgery
| Study group | Role | What they receive |
|---|---|---|
| Prosthesis | Experimental | 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). Receives: Procedure: Hincisional hernia prevention by onlay prosthesis trocar closure; Procedure: laparoscopic cholecystectomy; Diagnostic Test: Abdominal ultrasound |
| Control | Active comparator | 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. Receives: Procedure: laparoscopic cholecystectomy; Diagnostic Test: Abdominal ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 12 months
Secondary outcomes (2)
Perioperative complications
Secondary endpoints will be perioperative complications, including wound infection, haematoma, pain and reoperation.
Measured: 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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2021
- Study start2 Mar 2021
- Primary completionNov 2024 (estimated)
- Study completionFeb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Incisional HerniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Bicentric Randomized Controlled Trial. 2 allocation groups, parallel. Single blind. Enrollment: consecutive cases Time Perspective: Prospective
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 94 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Universitari Joan XXIII de Tarragona.
- Sponsor type
- University, hospital or other
- Collaborators
- Institut de Diagnostic per la Imatge, Institut Investigacio Sanitaria Pere Virgili
- Responsible party
- Principal investigator, Joan Ferreres i Serafini, Hospital Universitari Joan XXIII de Tarragona.
- Investigators
- Carles Olona Casas, MD, Study director, Hospital Universitari de Tarragona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04699201
- Sponsor's protocol ID
- 156/2020
- Acronym
- PHIT
- Status last verified
- Oct 2024
- First submitted
- 6 Jan 2021
- Last updated
- 2 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevenció De L'Hèrnia Incisional Per Tròcar
- ClinicalTrials.gov ID
- NCT04699201
- Acronym / sponsor ID
- PHIT / 156/2020
- Conditions
- Incisional Hernia
- Keywords
- Incisional Hernia, Umbilical Trocar, Preventive mesh
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 94 participants (estimated)
- Lead sponsor
- Hospital Universitari Joan XXIII de Tarragona.University, hospital or other
- Collaborators
- Institut de Diagnostic per la Imatge, Institut Investigacio Sanitaria Pere Virgili
- Study start
- 2 Mar 2021 (actual)
- Primary completion
- Nov 2024 (estimated)
- Study completion
- Feb 2025 (estimated)
- First posted
- 7 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Bicentric Randomized Controlled Trial. 2 allocation groups, parallel. Single blind. Enrollment: consecutive cases Time Perspective: Prospective
| Arm | Type | Receives |
|---|---|---|
| Prosthesis | Experimental | Procedure: Hincisional hernia prevention by onlay prosthesis trocar closure, Procedure: laparoscopic cholecystectomy, Diagnostic Test: Abdominal ultrasoundFirstly, 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). |
| Control | Active comparator | Procedure: laparoscopic cholecystectomy, Diagnostic Test: Abdominal ultrasoundFirstly, 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. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hincisional hernia prevention by onlay prosthesis trocar closureHincisional hernia prevention by onlay prosthesis trocar closure | Procedure or surgery | Prosthesis |
| laparoscopic cholecystectomyLaparoscopic cholecystectomy with or without common bile duct exploration | Procedure or surgery | Control, Prosthesis |
| Abdominal ultrasoundUltrasound focused in abdominal wall defects on the trocar incisions, 12 months after the surgery | Diagnostic test | Control, Prosthesis |
Primary outcome
Incidence of incisional hernia
Time frame: 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).
2 secondary outcomes
Perioperative complications
Time frame: 30 days
Economical impact
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2024.
- Individual participant dataSharing planned: No
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SUTURE TYPE AND RECURRENCE RISK AFTER INCISIONAL HERNIA REPAIR
Ventral Incisional Hernia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rosa Jorba Martin, MD contact
Carles Olona Casas, MD study director
Hospital Universitari de Tarragona
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hincisional hernia prevention by onlay prosthesis trocar closure, laparoscopic cholecystectomy and Abdominal ultrasound in people with Incisional Hernia, run by Hospital Universitari Joan XXIII de Tarragona. at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Joan Ferreres Serafini, MD ((+34) 657920793, joanfs8@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of incisional hernia (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2024.