Incisional Hernia After Midline LaparotomyParthenopeNCT04471311
Safety and Efficacy of Prophylactic Re-sorbable Biosynthetic Mesh Following Midline Laparotomy in Clean/Contaminated Field.
A study testing Sub-lay mesh supported closure and BIO-A (GORE) mesh in people with Incisional Hernia After Midline Laparotomy, run by Azienda Sanitaria Locale Napoli 2 Nord at 1 site in Italy.
Trial summary
The aim of the present study is to analyse the feasibility, safety and IH rate using a prophylactic sublay biosynthetic BIO-A (GORE) mesh in order to prevent incisional hernia following midline laparotomy in clean-contaminated and contaminated wounds. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Incisional Hernia After Midline Laparotomy
- What is being tested?
- Sub-lay mesh supported closure and BIO-A (GORE) mesh
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 151 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2024to 30 Jun 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age > 18 years
- Clean-contaminated, contaminated wounds • midline laparotomy >10 cm
- Informed consent
Who cannot join
- age < 18 years;
- life expectancy < 24 months (as estimated by the operating surgeon), - • pregnancy
- immunosuppressant therapy within 2 weeks before surgery
- clean and dirty wounds
- wound length<10 cm.
Trial locations and contacts
1 site in 1 country.
Francesco Pizza contact
Italy1 site, 1 recruiting
- Recruiting
francesco Pizza
Naples
francesco pizza, md phd, francesco_pizza@libero.it
dario dantonio, md, dario.dantonio@libero.it
About this study
Official title: Safety and Efficacy of Prophylactic Resorbable Biosynthetic Mesh Following Midline Laparotomy in Clean/Contaminated Field: Protocol for a Multicenter Randomized Double Blind Prospected Trial.
The aim of the present study is to analyse the feasibility, safety and IH rate using a prophylactic sublay biosynthetic BIO-A (GORE) mesh in order to prevent incisional hernia following midline laparotomy in clean-contaminated and contaminated wounds. The study was designed as a double-blind randomized controlled trial comparing the running suture alone to the running suture reinforced with biosynthetic mesh (BIOA) in sub lay position.
Read the detailed description
Incisional Hernia (IH) is one of the most frequent postoperative complications in abdominal surgery causing significant morbidity and even mortality. The risk of developing an IH following primary elective midline laparotomy is reported to be between 5 and 20 percent. Risk factors for developing IH are both patient and surgery related. Patient factors include diabetes, smoking, obesity, chronic corticosteroids use and connective tissue disorders, comprised the presence of an Abdominal Aortic Aneurysm (AAA). Surgery related factors include type of laparotomy, type of surgery, wounds classification, suture material used to close the laparotomy and the suture length to wound length ratio (SL/WL).
In patients carrying AAA and/or obesity and/or contaminated wounds, incidence rises to 39% (6,7). Besides the negative impact of incisional hernia regarding the patients' quality of life, the direct costs of hernia repair and indirect cost of IH (sick leave) are an important burden for the health care system.
Several groups investigated the role of prophylactic mesh placement in the prevention of IH occurrence. A positive conclusion was reached by two systemic reviews. On the other side, surgeons are mostly reluctant to implant permanent material in patients undergoing a contaminated ventral hernia repair for the increased risk of postoperative infections, bowel adhesions, mesh extrusion and/or erosion, fistula formation, seroma development and pain.
Recently, a retrospective study by Carbonell et al. investigated the feasibility and outcomes of open ventral hernia repairs performed with a polypropylene mesh in the retro-rectus position in clean-contaminated and contaminated fields, reporting a 30-day surgical site infection rate of 7.1 and 19.0% respectively. The most appropriate mesh for hernia repair in clean-contaminated and contaminated fields is not as clear .
Some other authors proposed the implant of Biological Meshes (BM) in contaminated and dirty wounds, but their high costs limited their use. Moreover, data about long-term durability of biologic grafts used in case of complex abdominal wall reconstruction are not clearly defined. The so-called biosynthetic meshes (BSM) may, actually, offer advantages when challenging with bacterial colonization during complex abdominal wall reconstruction.
The GORE BIO-A Tissue Reinforcement is a BSM composed of a bio-absorbable polyglycolide-trimethylene carbonate copolymer, which is gradually absorbed by the body.
The aim of the present study is to analyse the feasibility, safety and IH rate using a prophylactic sublay biosynthetic BIO-A (GORE) mesh in order to prevent incisional hernia following midline laparotomy in clean-contaminated and contaminated wounds. The study was designed as a double-blind randomized controlled trial comparing the running suture alone to the running suture reinforced with biosynthetic mesh (BIOA) in sub lay position.
- Being tested
- Sub-lay mesh supported closure, BIO-A (GORE) mesh
- Keywords
- Incisional Hernia, Midline laparotomy, Contaminated wound
- Medical subject headings
- Incisional Hernia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sub-lay mesh supported closureProcedure or surgery
A 4 cm space is created between posterior rectus sheath and rectus muscle, widening 2 cm at each side of midline. Both posterior rectus sheath edges are sutured using a running slowly absorbable suture. Above the arcuate line, posterior layer is reinforced suturing the peritoneum and the posterior rectus sheath; below the arcuate line, the posterior layer is reinforced suturing the peritoneum and the trasversalis fascia. Anterior layer is re-established suturing the anterior rectus sheath. A 3 cm BIO-A Mesh strip is sutureless placed between the posterior rectus sheath and the rectus muscle with an overlap of 1,5 cm at each side. In laparotomies >20 cm two stripes of 15 cm each is designed. The midline anterior rectus sheath is closed using a running slowly absorbable suture , covering the mesh.
BIO-A (GORE) meshDevice
3 cm BIO-A Mesh strip
| Study group | Role | What they receive |
|---|---|---|
| Primary closure of midline laparotomy | No intervention | Primary closure of midline laparotomy |
| Sub-lay mesh supported closure | Experimental | Sub-lay permanent mesh supported the closure Receives: Procedure: Sub-lay mesh supported closure; Device: BIO-A (GORE) mesh |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Incisional Hernia at Ultrasound examination
Ultrasound imaging is performed to examine the midline for all patients with symptomatic or asymptomatic, providing any valuable information about Incisional Hernia onset. Size and location of all ultrasound detected Incisional Hernia are registered, as well as any other patient's complaint. The ultrasonic criteria of Incisional Hernia are a visible gap within the abdominal wall and/or ''tissue moving through the abdominal wall by Valsalva manoeuvre'' and/or a detectable ''blowout''. Incisional Hernia is diagnosed if clinical criteria and/or ultrasound criteria are fulfilled.
Measured: 3 months
Rate of Incisional Hernia at Ultrasound examination
Ultrasound imaging is performed to examine the midline for all patients with symptomatic or asymptomatic, providing any valuable information about Incisional Hernia onset. Size and location of all ultrasound detected Incisional Hernia are registered, as well as any other patient's complaint. The ultrasonic criteria of Incisional Hernia are a visible gap within the abdominal wall and/or ''tissue moving through the abdominal wall by Valsalva manoeuvre'' and/or a detectable ''blowout''. Incisional Hernia is diagnosed if clinical criteria and/or ultrasound criteria are fulfilled.
Measured: 6 months
Rate of Incisional Hernia at Ultrasound examination
Ultrasound imaging is performed to examine the midline for all patients with symptomatic or asymptomatic, providing any valuable information about Incisional Hernia onset. Size and location of all ultrasound detected Incisional Hernia are registered, as well as any other patient's complaint. The ultrasonic criteria of Incisional Hernia are a visible gap within the abdominal wall and/or ''tissue moving through the abdominal wall by Valsalva manoeuvre'' and/or a detectable ''blowout''. Incisional Hernia is diagnosed if clinical criteria and/or ultrasound criteria are fulfilled.
Measured: 12 months
Rate of Incisional Hernia at Ultrasound examination
Ultrasound imaging is performed to examine the midline for all patients with symptomatic or asymptomatic, providing any valuable information about Incisional Hernia onset. Size and location of all ultrasound detected Incisional Hernia are registered, as well as any other patient's complaint. The ultrasonic criteria of Incisional Hernia are a visible gap within the abdominal wall and/or ''tissue moving through the abdominal wall by Valsalva manoeuvre'' and/or a detectable ''blowout''. Incisional Hernia is diagnosed if clinical criteria and/or ultrasound criteria are fulfilled.
Measured: 24 months
Rate of Incisional Hernia at Clinical examination
Clinical examination: Incisional Hernia is clinically defined as any visible or palpable ''blowout'' in the midline abdominal scar
Measured: 3 months
Rate of Incisional Hernia at Clinical examination
Clinical examination: Incisional Hernia is clinically defined as any visible or palpable ''blowout'' in the midline abdominal scar
Measured: 6 months
Rate of Incisional Hernia at Clinical examination
Clinical examination: Incisional Hernia is clinically defined as any visible or palpable ''blowout'' in the midline abdominal scar
Measured: 12 months
Rate of Incisional Hernia at Clinical examination
Clinical examination: Incisional Hernia is clinically defined as any visible or palpable ''blowout'' in the midline abdominal scar
Measured: 24 months
Secondary outcomes (2)
Number of patients affected by Superficial surgical site infections
Superficial infections according to Clavien-Dindo criteria
Measured: Within 30 days postoperatively
Number of patients affected by Deep surgical site infections
Deep surgical site infections according to Clavien-Dindo criteria
Measured: Within 30 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2020
- Study start1 Jan 2024 (estimated)
- Primary completion30 Jun 2024 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Incisional Hernia After Midline LaparotomyStudies 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
- THIS IS A CONTROLLED RANDOMIZED STUDY OF BINARY SUPERIORITY OUTCOME IN PARALLEL GROUPS. 302 PATIENTS ARE REQUIRED TO HAVE A 95% CHANCE OF DETECTING, AS SIGNIFICANT AT THE 5% LEVEL, A DECREASE IN THE PRIMARY OUTCOME MEASURE FROM 18% (INCISIONAL HERNIA RATE) IN THE CONTROL GROUP TO 5%(INCISIONAL HERNIA RATE) IN THE EXPERIMENTAL GROUP.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 151 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Sanitaria Locale Napoli 2 Nord
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francesco Pizza, Azienda Sanitaria Locale Napoli 2 Nord
- Investigators
- Francesco Pizza, Study director, Azienda Sanitaria Locale Napoli 2 Nord
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04471311
- Sponsor's protocol ID
- 1872020
- Acronym
- Parthenope
- Status last verified
- Oct 2023
- First submitted
- 10 Jul 2020
- Last updated
- 30 Oct 2023
- 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 30 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Prophylactic Resorbable Biosynthetic Mesh Following Midline Laparotomy in Clean/Contaminated Field: Protocol for a Multicenter Randomized Double Blind Prospected Trial.
- ClinicalTrials.gov ID
- NCT04471311
- Acronym / sponsor ID
- Parthenope / 1872020
- Keywords
- Incisional Hernia, Midline laparotomy, Contaminated wound
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 151 participants (estimated)
- Lead sponsor
- Azienda Sanitaria Locale Napoli 2 NordUniversity, hospital or other
- Study start
- 1 Jan 2024 (estimated)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 15 Jul 2020 (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.
The aim of the present study is to analyse the feasibility, safety and IH rate using a prophylactic sublay biosynthetic BIO-A (GORE) mesh in order to prevent incisional hernia following midline laparotomy in clean-contaminated and contaminated wounds. The study was designed as a double-blind randomized controlled trial comparing the running suture alone to the running suture reinforced with biosynthetic mesh (BIOA) in sub lay position.
Detailed description
Incisional Hernia (IH) is one of the most frequent postoperative complications in abdominal surgery causing significant morbidity and even mortality. The risk of developing an IH following primary elective midline laparotomy is reported to be between 5 and 20 percent. Risk factors for developing IH are both patient and surgery related. Patient factors include diabetes, smoking, obesity, chronic corticosteroids use and connective tissue disorders, comprised the presence of an Abdominal Aortic Aneurysm (AAA). Surgery related factors include type of laparotomy, type of surgery, wounds classification, suture material used to close the laparotomy and the suture length to wound length ratio (SL/WL).
In patients carrying AAA and/or obesity and/or contaminated wounds, incidence rises to 39% (6,7). Besides the negative impact of incisional hernia regarding the patients' quality of life, the direct costs of hernia repair and indirect cost of IH (sick leave) are an important burden for the health care system.
Several groups investigated the role of prophylactic mesh placement in the prevention of IH occurrence. A positive conclusion was reached by two systemic reviews. On the other side, surgeons are mostly reluctant to implant permanent material in patients undergoing a contaminated ventral hernia repair for the increased risk of postoperative infections, bowel adhesions, mesh extrusion and/or erosion, fistula formation, seroma development and pain.
Recently, a retrospective study by Carbonell et al. investigated the feasibility and outcomes of open ventral hernia repairs performed with a polypropylene mesh in the retro-rectus position in clean-contaminated and contaminated fields, reporting a 30-day surgical site infection rate of 7.1 and 19.0% respectively. The most appropriate mesh for hernia repair in clean-contaminated and contaminated fields is not as clear .
Some other authors proposed the implant of Biological Meshes (BM) in contaminated and dirty wounds, but their high costs limited their use. Moreover, data about long-term durability of biologic grafts used in case of complex abdominal wall reconstruction are not clearly defined. The so-called biosynthetic meshes (BSM) may, actually, offer advantages when challenging with bacterial colonization during complex abdominal wall reconstruction.
The GORE BIO-A Tissue Reinforcement is a BSM composed of a bio-absorbable polyglycolide-trimethylene carbonate copolymer, which is gradually absorbed by the body.
The aim of the present study is to analyse the feasibility, safety and IH rate using a prophylactic sublay biosynthetic BIO-A (GORE) mesh in order to prevent incisional hernia following midline laparotomy in clean-contaminated and contaminated wounds. The study was designed as a double-blind randomized controlled trial comparing the running suture alone to the running suture reinforced with biosynthetic mesh (BIOA) in sub lay position.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- THIS IS A CONTROLLED RANDOMIZED STUDY OF BINARY SUPERIORITY OUTCOME IN PARALLEL GROUPS. 302 PATIENTS ARE REQUIRED TO HAVE A 95% CHANCE OF DETECTING, AS SIGNIFICANT AT THE 5% LEVEL, A DECREASE IN THE PRIMARY OUTCOME MEASURE FROM 18% (INCISIONAL HERNIA RATE) IN THE CONTROL GROUP TO 5%(INCISIONAL HERNIA RATE) IN THE EXPERIMENTAL GROUP.
| Arm | Type | Receives |
|---|---|---|
| Primary closure of midline laparotomy | No intervention | –Primary closure of midline laparotomy |
| Sub-lay mesh supported closure | Experimental | Procedure: Sub-lay mesh supported closure, Device: BIO-A (GORE) meshSub-lay permanent mesh supported the closure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age > 18 years
- Clean-contaminated, contaminated wounds • midline laparotomy >10 cm
- Informed consent
Key exclusion criteria (5 listed)
- age < 18 years;
- life expectancy < 24 months (as estimated by the operating surgeon), - • pregnancy
- immunosuppressant therapy within 2 weeks before surgery
- clean and dirty wounds
- wound length<10 cm.
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 |
|---|---|---|
| Sub-lay mesh supported closureA 4 cm space is created between posterior rectus sheath and rectus muscle, widening 2 cm at each side of midline. Both posterior rectus sheath edges are sutured using a running slowly absorbable suture. Above the arcuate line, posterior layer is reinforced suturing the peritoneum and the posterior rectus sheath; below the arcuate line, the posterior layer is reinforced suturing the peritoneum and the trasversalis fascia. Anterior layer is re-established suturing the anterior rectus sheath. A 3 cm BIO-A Mesh strip is sutureless placed between the posterior rectus sheath and the rectus muscle with an overlap of 1,5 cm at each side. In laparotomies >20 cm two stripes of 15 cm each is designed. The midline anterior rectus sheath is closed using a running slowly absorbable suture , covering the mesh. | Procedure or surgery | Sub-lay mesh supported closure |
| BIO-A (GORE) mesh3 cm BIO-A Mesh strip | Device | Sub-lay mesh supported closure |
Primary outcome
Rate of Incisional Hernia at Ultrasound examination
Time frame: 3 months
Ultrasound imaging is performed to examine the midline for all patients with symptomatic or asymptomatic, providing any valuable information about Incisional Hernia onset. Size and location of all ultrasound detected Incisional Hernia are registered, as well as any other patient's complaint. The ultrasonic criteria of Incisional Hernia are a visible gap within the abdominal wall and/or ''tissue moving through the abdominal wall by Valsalva manoeuvre'' and/or a detectable ''blowout''. Incisional Hernia is diagnosed if clinical criteria and/or ultrasound criteria are fulfilled.
Rate of Incisional Hernia at Ultrasound examination
Time frame: 6 months
Ultrasound imaging is performed to examine the midline for all patients with symptomatic or asymptomatic, providing any valuable information about Incisional Hernia onset. Size and location of all ultrasound detected Incisional Hernia are registered, as well as any other patient's complaint. The ultrasonic criteria of Incisional Hernia are a visible gap within the abdominal wall and/or ''tissue moving through the abdominal wall by Valsalva manoeuvre'' and/or a detectable ''blowout''. Incisional Hernia is diagnosed if clinical criteria and/or ultrasound criteria are fulfilled.
Rate of Incisional Hernia at Ultrasound examination
Time frame: 12 months
Ultrasound imaging is performed to examine the midline for all patients with symptomatic or asymptomatic, providing any valuable information about Incisional Hernia onset. Size and location of all ultrasound detected Incisional Hernia are registered, as well as any other patient's complaint. The ultrasonic criteria of Incisional Hernia are a visible gap within the abdominal wall and/or ''tissue moving through the abdominal wall by Valsalva manoeuvre'' and/or a detectable ''blowout''. Incisional Hernia is diagnosed if clinical criteria and/or ultrasound criteria are fulfilled.
Rate of Incisional Hernia at Ultrasound examination
Time frame: 24 months
Ultrasound imaging is performed to examine the midline for all patients with symptomatic or asymptomatic, providing any valuable information about Incisional Hernia onset. Size and location of all ultrasound detected Incisional Hernia are registered, as well as any other patient's complaint. The ultrasonic criteria of Incisional Hernia are a visible gap within the abdominal wall and/or ''tissue moving through the abdominal wall by Valsalva manoeuvre'' and/or a detectable ''blowout''. Incisional Hernia is diagnosed if clinical criteria and/or ultrasound criteria are fulfilled.
Rate of Incisional Hernia at Clinical examination
Time frame: 3 months
Clinical examination: Incisional Hernia is clinically defined as any visible or palpable ''blowout'' in the midline abdominal scar
Rate of Incisional Hernia at Clinical examination
Time frame: 6 months
Clinical examination: Incisional Hernia is clinically defined as any visible or palpable ''blowout'' in the midline abdominal scar
Rate of Incisional Hernia at Clinical examination
Time frame: 12 months
Clinical examination: Incisional Hernia is clinically defined as any visible or palpable ''blowout'' in the midline abdominal scar
Rate of Incisional Hernia at Clinical examination
Time frame: 24 months
Clinical examination: Incisional Hernia is clinically defined as any visible or palpable ''blowout'' in the midline abdominal scar
2 secondary outcomes
Number of patients affected by Superficial surgical site infections
Time frame: Within 30 days postoperatively
Number of patients affected by Deep surgical site infections
Time frame: Within 30 days postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2023.
- Individual participant dataSharing planned: No
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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.
Francesco Pizza contact
Francesco Pizza study director
Azienda Sanitaria Locale Napoli 2 Nord
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sub-lay mesh supported closure and BIO-A (GORE) mesh in people with Incisional Hernia After Midline Laparotomy, run by Azienda Sanitaria Locale Napoli 2 Nord at 1 site in Italy.
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 3 inclusion and 5 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 30 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. 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 Francesco Pizza (3338275449, francesco_pizza@libero.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Incisional Hernia at Ultrasound examination (time frame: 3 months). The study lists 8 primary outcomes in all. 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 30 Oct 2023.