Incisional LLQ HerniaNCT04538768
Prevention of Lateral Incisional Hernia After Stomal Closure Using P4HB Retro-muscular Mesh
A study testing Mesh augmentation and Direct suture in people with Incisional LLQ Hernia, run by Buccheri La Ferla Hospital, Palermo at 1 site in Italy.
Trial summary
The aim of the study is to determine whether the use of the P4HB retro muscular mesh can prevent the lateral incisional hernia after stomal closure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Incisional LLQ Hernia
- What is being tested?
- Mesh augmentation and Direct suture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteItaly
- Study dates
- Oct 2020to Apr 2023
- 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
- patients > 18 y.o.
- stomal closure
- elective surgery
Who cannot join
- patients < 18 y.o.
- emergency surgery
Trial locations and contacts
1 site in 1 country.
Italy1 site
Ospedale Buccheri La Ferla Palermo
Palermo, 90100
Leo Licari, MD, +39 3401710089, lele.licari@gmail.com
Cosimo Callari, MD, +39 3394574404, cosimo.callari@gmail.com
About this study
The aim of the study is to determine whether the use of the P4HB retro muscular mesh can prevent the lateral incisional hernia after stomal closure.
- Conditions
- Incisional LLQ Hernia
- Being tested
- Mesh augmentation, Direct suture
- Keywords
- lateral incisional hernia, mesh augmentation, prevention, stomal closure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mesh augmentationProcedure or surgery
P4HB retromuscular mesh placement for prevention of lateral incisional hernia after stomal closure
Direct sutureProcedure or surgery
direct fascia suture
| Study group | Role | What they receive |
|---|---|---|
| Mesh Augmentated | Experimental | Not described Receives: Procedure: Mesh augmentation |
| Direct Suture | Other | Not described Receives: Procedure: Direct suture |
What is being measured
The primary outcome is the main question the study is designed to answer.
rate of postoperative lateral incisional hernia after P4HB mesh placement vs direct fascia suture.
the outcome 1 will be assessed through clinical examination during follow up time. when the suspicion of incisional hernia will be hypothesized the patients will be conducted to perform US of the abdomen and CT scan of the abdomen if strictly required to confirm the suspicion.
Measured: 1 week to 18 months after surgery
Secondary outcomes (7)
surgical operation time in P4HB mesh placement group vs direct fascia suture group.
outcome 2 will be assessed through the measurement of the length of surgical operation. The length of the surgical operation will be measured in minutes from the incision of the skin to the suture of the skin. data will be compared with those of the control arm (direct fascia suture) to understand the feasibility of the technique proposed.
Measured: intraoperative
length of hospital stay in P4HB mesh placement group vs direct fascia suture group.
outcome 3 will be assessed through the measurement of the length of the hospital stay. The length of hospital stay will be measured in days from admission to dimission of the patient. Data will be compared with those of the control arm (direct fascia suture).
Measured: From the starting date of the study until the date of its completion, assessed up to 18 months"
rate of surgical site infection in P4HB mesh placement group vs direct fascia suture group.
outcome 4 will be assessed through clinical examination during follow up time evaluating the rate of postoperative complication such as surgical site infection.
Measured: 1 week after surgery; 1 month after surgery; 3 months after surgery; 6 months after surgery; 12 months after surgery; 18 months after surgery
rate of seroma formation in P4HB mesh placement group vs direct fascia suture group.
outcome 5 will be assessed through clinical examination during follow up time evaluating the rate of postoperative complications such as seroma.
Measured: 1 week after surgery; 1 month after surgery; 3 months after surgery; 6 months after surgery; 12 months after surgery; 18 months after surgery
rate of hematoma formation in P4HB mesh placement group vs direct fascia suture group.
outcome 6 will be assessed through clinical examination during follow up time evaluating the rate of postoperative complications such as hematoma.
Measured: 1 week after surgery; 1 month after surgery; 3 months after surgery; 6 months after surgery; 12 months after surgery; 18 months after surgery
assessment of quality of life (QoL) through QoL scale in P4HB mesh placement group vs direct fascia suture group.
outcome 7 will be assessed through assessment of the postoperative QoL. The SF-36 questionnaire will be administered post-operatively.
The 36-Item Short Form Health Survey questionnaire (SF-36) is a very popular instrument for evaluating Health-Related Quality of Life.
The SF-36, as described in the name, is a 36-item patient-reported questionnaire that covers eight health domains: physical functioning (10 items), bodily pain (2 items), role limitations due to physical health problems (4 items), role limitations due to personal or emotional problems (4 items), emotional well-being (5 items), social functioning (2 items), energy/fatigue (4 items), and general health perceptions (5 items). Scores for each domain range from 0 to 100, with a higher score defining a more favorable health state.
Measured: 18 months after surgery.
cost effectiveness analysis of the P4HB mesh augmentation technique vs direct fascia suture group.
the outcome 8 will be assessed through the collection of data about the total costs for the surgical operation and the hospitalization considering materials and mesh used. The analysis will be used to compare the costs of the technique proposed with those of the incisional hernia management in order to conduct a cost effectiveness analysis.
Measured: through study completion, an average of 1 year .
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2020
- Study startOct 2020 (estimated)
- Primary completionOct 2021 (estimated)
- Study completionApr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Incisional LLQ 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
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Buccheri La Ferla Hospital, Palermo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leo Licari, Buccheri La Ferla Hospital, Palermo
- Investigators
- Leo Licari, MD, Study director, Ospedale Buccheri La Ferla Palermo; University of Palermo - Department of Surgical, Oncological and Oral SciencesCosimo Callari, MD, Study chair, Ospedale Buccheri La Ferla Palermo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04538768
- Sponsor's protocol ID
- 20082020
- Status last verified
- Aug 2020
- First submitted
- 22 Aug 2020
- Last updated
- 4 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Lateral Incisional Hernia After Stomal Closure Using P4HB Retro-muscular Mesh
- ClinicalTrials.gov ID
- NCT04538768
- Acronym / sponsor ID
- 20082020
- Conditions
- Incisional LLQ Hernia
- Keywords
- lateral incisional hernia, mesh augmentation, prevention, stomal closure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Buccheri La Ferla Hospital, PalermoUniversity, hospital or other
- Study start
- Oct 2020 (estimated)
- Primary completion
- Oct 2021 (estimated)
- Study completion
- Apr 2023 (estimated)
- First posted
- 4 Sep 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 study is to determine whether the use of the P4HB retro muscular mesh can prevent the lateral incisional hernia after stomal closure.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mesh Augmentated | Experimental | Procedure: Mesh augmentation |
| Direct Suture | Other | Procedure: Direct suture |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients > 18 y.o.
- stomal closure
- elective surgery
Key exclusion criteria (2 listed)
- patients < 18 y.o.
- 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 |
|---|---|---|
| Mesh augmentationP4HB retromuscular mesh placement for prevention of lateral incisional hernia after stomal closure | Procedure or surgery | Mesh Augmentated |
| Direct suturedirect fascia suture | Procedure or surgery | Direct Suture |
Primary outcome
rate of postoperative lateral incisional hernia after P4HB mesh placement vs direct fascia suture.
Time frame: 1 week to 18 months after surgery
the outcome 1 will be assessed through clinical examination during follow up time. when the suspicion of incisional hernia will be hypothesized the patients will be conducted to perform US of the abdomen and CT scan of the abdomen if strictly required to confirm the suspicion.
7 secondary outcomes
surgical operation time in P4HB mesh placement group vs direct fascia suture group.
Time frame: intraoperative
length of hospital stay in P4HB mesh placement group vs direct fascia suture group.
Time frame: From the starting date of the study until the date of its completion, assessed up to 18 months"
rate of surgical site infection in P4HB mesh placement group vs direct fascia suture group.
Time frame: 1 week after surgery; 1 month after surgery; 3 months after surgery; 6 months after surgery; 12 months after surgery; 18 months after surgery
rate of seroma formation in P4HB mesh placement group vs direct fascia suture group.
Time frame: 1 week after surgery; 1 month after surgery; 3 months after surgery; 6 months after surgery; 12 months after surgery; 18 months after surgery
rate of hematoma formation in P4HB mesh placement group vs direct fascia suture group.
Time frame: 1 week after surgery; 1 month after surgery; 3 months after surgery; 6 months after surgery; 12 months after surgery; 18 months after surgery
assessment of quality of life (QoL) through QoL scale in P4HB mesh placement group vs direct fascia suture group.
Time frame: 18 months after surgery.
cost effectiveness analysis of the P4HB mesh augmentation technique vs direct fascia suture group.
Time frame: through study completion, an average of 1 year .
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2020.
- Individual participant dataSharing planned: Yes
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.
Leo Licari, MD study director
Ospedale Buccheri La Ferla Palermo; University of Palermo - Department of Surgical, Oncological and Oral Sciences
Cosimo Callari, MD study chair
Ospedale Buccheri La Ferla Palermo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mesh augmentation and Direct suture in people with Incisional LLQ Hernia, run by Buccheri La Ferla Hospital, Palermo 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 2 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 4 Sep 2020. 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 Leo Licari, MD (+39 3401710089, lele.licari@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
rate of postoperative lateral incisional hernia after P4HB mesh placement vs direct fascia suture. (time frame: 1 week to 18 months after surgery). 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 4 Sep 2020.