Incisional HerniaPhase 4PREBIOUSNCT02208557
Usefulness of a Prothetic Absorbable Mesh in Incisional Hernia Prevention After Midline Laparotomy
A Phase 4 study testing Reinforcement with Absorbable Mesh and Clinical Follow Up in people with Incisional Hernia, run by Hospital Universitari Vall d'Hebron Research Institute at 6 sites in Spain.
Trial summary
Background: Development of an incisional hernia is one of the most frequent complications of midline laparotomies requiring reoperation. This paper presents the rationale, design, and study protocol for a randomized controlled trial, the aim of which was to evaluate the efficacy and safety of prophylactically placing… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Incisional Hernia
- What is being tested?
- Reinforcement with Absorbable Mesh and Clinical Follow Up
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 488 participants
- Where
- 6 sitesSpain
- Study dates
- Jul 2014to Jul 2015
- Phase
- Phase 4
- 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
- Adults aged 18 years or older,
- Signed informed consent,
- Patients undergoing elective or urgent open abdominal surgical procedures regardless of benign or malignant disease.
Who cannot join
- Presence of primary or recurrent incisional hernia
- Expected survival < 12 months.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Spain6 sites, 6 recruiting
- Recruiting
Hospital del Mar, Parc de Salut Mar
Barcelona, Barcelona, 08003
Jose Antonio Pereira, Md, PhD, japerneira@gmail.com
Jose Antonio Pereira, MD, PhD
- Recruiting
Hospital Universitari Vall d'Hebron
Barcelona, Barcelona, 08035
Manuel Lopez-Cano, MD, PhD, +34 - 93274600 ext. 6587, mlpezcano@gmail.com
Manuel Lopez-Cano, MD, PhD
- Recruiting
Hospital de Igualada
Igualada, Barcelona, 08700
Xavier Feliú, MD, PhD, 16255xfp@comb.cat
Xavier Feliú, MD, PhD
- Recruiting
Hospital Arnau de Vilanova
Lleida, Lerida, 25198
Rafael Villalobos, MD, rafovilla26@gmail.com
Rafael Villalobos, MD
- Recruiting
Hospital Parc Taulí
Sabadell, Barcelona, 08208
Salvador Navarro, MD, PhD, snavarro@tauli.cat
Salvador Navarro, MD,PhD
- Recruiting
Hospital de Sagunto
Sagunto, Valencia, 46520
Roberto Lozoya, MD, PhD, rlozoya@aecirujanos.es
Roberto Lozoya, MD, PhD
About this study
Official title: PREBIOUS Trial : A Multicenter Randomized Controlled Trial of Preventive Midline Laparotomy Closure With a Bioabsorbable Mesh for the Prevention of Incisional Hernia.
Background: Development of an incisional hernia is one of the most frequent complications of midline laparotomies requiring reoperation. This paper presents the rationale, design, and study protocol for a randomized controlled trial, the aim of which was to evaluate the efficacy and safety of prophylactically placing a bioabsorbable synthetic mesh for reinforcement of a midline fascial closure.
Methods: The PREBIOUS trial (PREventive midline laparotomy closure with a BIOabsorbable mesh) is a multicenter randomized controlled trial in which adult patients undergoing elective or urgent open abdominal operations through a midline laparotomy incision are assigned to one of two groups based on the laparotomy closure procedure: an intervention group in which a continuous polydioxanone (PDS) suture is reinforced with a commercially available GORE® BIO-A® Tissue Reinforcement prosthesis (W. L. Gore \& Associates, Flagstaff, Arizona, USA), or a control group with continuous PDS suture only. Both groups are followed over 6 months.
Outcomes: The primary outcome is the appearance of incisional hernias assessed by physical examination at clinical visits and radiologically (CT scan) performed at the end of follow-up. Secondary outcomes are the rate of complications, mainly infection, hematoma, burst abdomen, pain, and reoperation. The PREBIOUS trial has the potential to demonstrate that suture plus prosthetic mesh insertion for routine midline laparotomy closure is effective in preventing incisional hernias after open abdominal surgery, to avoid the effects on those affected, such as poor cosmesis, social embarrassment, or impaired quality of life, and to save costs potentially associated with incisional hernia surgical repair.
- Conditions
- Incisional Hernia
- Being tested
- Reinforcement with Absorbable Mesh, Control CT, Clinical Follow Up
- Keywords
- Incisional hernia, prevention, laparotomy closure, absorbable 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.
Reinforcement with Absorbable MeshProcedure or surgery
Also called GORE® BIO-A® Tissue Reinforcement prosthesis, (W. L. Gore & Associates, Flagstaff, Arizona, USA) mesh., LNE/G-MED (CE) 0459
Control CTRadiation
At the end of the follow up (6 Months) a CT scan will be done. Radiologically the incisional hernia is defined as a solution of continuity of the linea alba seen on the abdominal CT scan with the patient at rest.
The radiologist is blinded to the patient's history and the technique used for midline fascial closure.
Clinical Follow UpOther
The presence of incisional hernia was evaluated by physical examination at scheduled clinical visits (3 and 6 months after surgery) Clinically, an incisional hernia is defined as the presence of a reducible bulge or protrusion at the laparotomy incision scar, palpable during the Valsalva maneuver.
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Laparotomy closure will be done by continuous PDS suture following a SL:WL ratio of 4:1 only is used for midline laparotomy closure. Receives: Radiation: Control CT; Other: Clinical Follow Up |
| Reinforcement with Absorbable Mesh | Experimental | Closure of the midline laparotomy incision is reinforced with insertion of a rectangular segment (1 cm wide and the length corresponding to the incision) of a prosthetic commercially available GORE® BIO-A® Tissue Reinforcement prosthesis (W. L. Gore \& Associates, Flagstaff, Arizona, USA) mesh. The BIO-A® prosthesis is inserted using a "sandwich" method between the edges of the incision and maintained in situ with a continuous polydioxanone (PDS) suture following a suture length to wound length (SL:WL) ratio of 4:1. Receives: Procedure: Reinforcement with Absorbable Mesh; Radiation: Control CT; Other: Clinical Follow Up |
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, either symptomatic or asymptomatic in the mesh and suture-only groups. Because appearance of an incisional hernia occurs within the first months after laparotomy, assessment of efficacy was carried out during scheduled clinical visits over a period of 6 months. The presence of incisional hernia was evaluated by physical examination at scheduled clinical visits and radiologically by an abdominal CT scan performed at the end of follow-up (6 months after operation).
Measured: 6 months
Secondary outcomes (1)
Perioperative complications
Secondary endpoints are perioperative complications, including wound infection, hematoma, eventration, pain, reoperation.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2014 (estimated)
- Study startJul 2014
- Primary completionJul 2015 (estimated)
- Study completionJul 2015 (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.
- More trials run by Hospital Universitari Vall d'Hebron Research InstituteThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 488 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Manuel Lopez-Cano, MD, PhD, Principal investigator, Hospital Universitari Vall d´Hebrón
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02208557
- Sponsor's protocol ID
- PR(AG)220/2013
- Acronym
- PREBIOUS
- Status last verified
- Aug 2014
- First submitted
- 2 May 2014
- Last updated
- 5 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PREBIOUS Trial : A Multicenter Randomized Controlled Trial of Preventive Midline Laparotomy Closure With a Bioabsorbable Mesh for the Prevention of Incisional Hernia.
- ClinicalTrials.gov ID
- NCT02208557
- Acronym / sponsor ID
- PREBIOUS / PR(AG)220/2013
- Conditions
- Incisional Hernia
- Keywords
- Incisional hernia, prevention, laparotomy closure, absorbable mesh
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 488 participants (estimated)
- Lead sponsor
- Hospital Universitari Vall d'Hebron Research InstituteUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Jul 2015 (estimated)
- Study completion
- Jul 2015 (estimated)
- First posted
- 5 Aug 2014 (estimated)
- 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.
Background: Development of an incisional hernia is one of the most frequent complications of midline laparotomies requiring reoperation. This paper presents the rationale, design, and study protocol for a randomized controlled trial, the aim of which was to evaluate the efficacy and safety of prophylactically placing a bioabsorbable synthetic mesh for reinforcement of a midline fascial closure.
Methods: The PREBIOUS trial (PREventive midline laparotomy closure with a BIOabsorbable mesh) is a multicenter randomized controlled trial in which adult patients undergoing elective or urgent open abdominal operations through a midline laparotomy incision are assigned to one of two groups based on the laparotomy closure procedure: an intervention group in which a continuous polydioxanone (PDS) suture is reinforced with a commercially available GORE® BIO-A® Tissue Reinforcement prosthesis (W. L. Gore \& Associates, Flagstaff, Arizona, USA), or a control group with continuous PDS suture only. Both groups are followed over 6 months.
Outcomes: The primary outcome is the appearance of incisional hernias assessed by physical examination at clinical visits and radiologically (CT scan) performed at the end of follow-up. Secondary outcomes are the rate of complications, mainly infection, hematoma, burst abdomen, pain, and reoperation. The PREBIOUS trial has the potential to demonstrate that suture plus prosthetic mesh insertion for routine midline laparotomy closure is effective in preventing incisional hernias after open abdominal surgery, to avoid the effects on those affected, such as poor cosmesis, social embarrassment, or impaired quality of life, and to save costs potentially associated with incisional hernia surgical repair.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Radiation: Control CT, Other: Clinical Follow UpLaparotomy closure will be done by continuous PDS suture following a SL:WL ratio of 4:1 only is used for midline laparotomy closure. |
| Reinforcement with Absorbable Mesh | Experimental | Procedure: Reinforcement with Absorbable Mesh, Radiation: Control CT, Other: Clinical Follow UpClosure of the midline laparotomy incision is reinforced with insertion of a rectangular segment (1 cm wide and the length corresponding to the incision) of a prosthetic commercially available GORE® BIO-A® Tissue Reinforcement prosthesis (W. L. Gore \& Associates, Flagstaff, Arizona, USA) mesh. The BIO-A® prosthesis is inserted using a "sandwich" method between the edges of the incision and maintained in situ with a continuous polydioxanone (PDS) suture following a suture length to wound length (SL:WL) ratio of 4:1. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults aged 18 years or older,
- Signed informed consent,
- Patients undergoing elective or urgent open abdominal surgical procedures regardless of benign or malignant disease.
Key exclusion criteria (2 listed)
- Presence of primary or recurrent incisional hernia
- Expected survival < 12 months.
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 |
|---|---|---|
| Reinforcement with Absorbable MeshAlso: GORE® BIO-A® Tissue Reinforcement prosthesis, (W. L. Gore & Associates, Flagstaff, Arizona, USA) mesh., LNE/G-MED (CE) 0459 | Procedure or surgery | Reinforcement with Absorbable Mesh |
| Control CTAt the end of the follow up (6 Months) a CT scan will be done. Radiologically the incisional hernia is defined as a solution of continuity of the linea alba seen on the abdominal CT scan with the patient at rest. The radiologist is blinded to the patient's history and the technique used for midline fascial closure. | Radiation | Control, Reinforcement with Absorbable Mesh |
| Clinical Follow UpThe presence of incisional hernia was evaluated by physical examination at scheduled clinical visits (3 and 6 months after surgery) Clinically, an incisional hernia is defined as the presence of a reducible bulge or protrusion at the laparotomy incision scar, palpable during the Valsalva maneuver. | Other | Control, Reinforcement with Absorbable Mesh |
Primary outcome
Incidence of incisional hernia
Time frame: 6 months
The primary endpoint is the incidence of incisional hernia, either symptomatic or asymptomatic in the mesh and suture-only groups. Because appearance of an incisional hernia occurs within the first months after laparotomy, assessment of efficacy was carried out during scheduled clinical visits over a period of 6 months. The presence of incisional hernia was evaluated by physical examination at scheduled clinical visits and radiologically by an abdominal CT scan performed at the end of follow-up (6 months after operation).
1 secondary outcome
Perioperative complications
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2014.
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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.
Manuel Lopez-Cano, MD, PhD principal investigator
Hospital Universitari Vall d´Hebrón
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Reinforcement with Absorbable Mesh and Clinical Follow Up in people with Incisional Hernia, run by Hospital Universitari Vall d'Hebron Research Institute at 6 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 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 5 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Manuel Lopez-Cano, MD, PhD (+34 - 932746000 ext. 6587, mlpezcano@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: 6 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 5 Aug 2014.