EventrationNCT03520465
Utility of a Supraaponeurotic Mesh as Prophylaxis of the Midline Eventration After an Oncological Colorrectal Resection
A study testing DynaMesh®-CICAT longitudinal measure 10x35 cm in people with Eventration, run by Instituto de Investigacion Sanitaria La Fe at 1 site in Spain.
Trial summary
Randomized prospective experimental study, in which the effect of a prophylactic mesh is assessed in the eventration rate diagnosed by CT at one year after surgery in patients with CRC who underwent elective intervention for supra-infraumbilical midline laparotomy, considering as treatment the supra-aponeurotic mesh… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Eventration
- What is being tested?
- DynaMesh®-CICAT longitudinal measure 10x35 cm
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 1 siteSpain
- Study dates
- 27 Jun 2016to Jun 2020
- 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
- Elective surgery for colorectal cancer.
- Surgery by middle laparotomy.
- Informed consent signed by the patient.
- Age > 18 years.
Who cannot join
- Midline hernia or eventration.
- Presence of mesh in the abdominal wall because of a previous surgery.
- Palliative surgery.
- Synchronous metastases (Stage IV cancer according to TNM).
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitario y Politécnico La Fe
Valencia
Laura Segura
About this study
Randomized prospective experimental study, in which the effect of a prophylactic mesh is assessed in the eventration rate diagnosed by CT at one year after surgery in patients with CRC who underwent elective intervention for supra-infraumbilical midline laparotomy, considering as treatment the supra-aponeurotic mesh positioning (experimental group), and comparing it to the standard closing with a continuous suture using slow absorption monofilament.
Read the detailed description
Randomized prospective experimental study, in which we evaluate patients with CRC who underwent elective intervention for supra-infraumbilical midline laparotomy in order to:
Main objective:
- To assess the effect of the prophylactic mesh in the eventration rate diagnosed by CT at one year after surgery in patients with CRC who underwent elective intervention for supra-infraumbilical midline laparotomy.
Secondary objectives:
- To compare the appearance of complications in the control group and in the experimental group.
- Compare costs derived from short and long-term mesh placement in both groups.
We consider as treatment the supra-aponeurotic mesh positioning (experimental group), and compare it to the standard closing with slow absorption monofilament.
- Conditions
- Eventration
- Being tested
- DynaMesh®-CICAT longitudinal measure 10x35 cm
- Medical subject headings
- Gastroschisis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DynaMesh®-CICAT longitudinal measure 10x35 cmDevice
| Study group | Role | What they receive |
|---|---|---|
| Supraaponeurotic mesh | Experimental | Patients with laparotomy closure by conventional approach of aponeurosis (continuous suture with monofilament of slow absorption), and posterior placement of supraaponeurotic mesh of polyvinylidene fluoride (PVDF) medium / low density and wide pore. The mesh has a longitudinal measurement that exceeds about 3 cm the upper and lower ends of the wound and width should not be less than 10 cm, therefore the mesh selected is DynaMesh®-CICAT longitudinal measure 10x35 cm.
The mesh is fixed to the aponeurosis with a crown of loose stitches and points to the midline. A prolene 2/0 non-reabsorbable monofilament suture of cylindrical needle is used.
A 10 Fr suction drainage is placed in the supraaponeurotic plane, with an exit to the exterior beyond the edges of the prosthesis. Drainage will be preserved for a minimum of 48 hours after surgery, and will be withdrawn when a debit of less than 50 ml is presented in 24 h. Receives: Device: DynaMesh®-CICAT longitudinal measure 10x35 cm |
| Monofilament | No intervention | Patients with conventional closure of the middle laparotomy with approach of aponeurosis in a plane by continuous suture with monofilament of slow absorption. In this study, the suture used in all patients will be poly-4-hydroxybutyrate or Mono-max loop®. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eventration rate
To assess the effect of the prophylactic mesh in the eventration rate diagnosed by CT at one year after surgery in patients with CRC who underwent elective intervention for supra-infraumbilical midline laparotomy.
Measured: 1 year
Secondary outcomes (2)
Complications rate
To compare the appearance of complications in the control group and in the experimental group.
Measured: 1 year
Short and long term derived costs
To compare the costs derived from short and long-term mesh placement in both groups.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2018
- Study start27 Jun 2016
- Primary completionJun 2020 (estimated)
- Study completionJun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EventrationStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 154 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto de Investigacion Sanitaria La Fe
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Matteo Frasson, Principal investigator, Instituto de Investigación Sanitaria La Fe
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03520465
- Sponsor's protocol ID
- PEACE
- Status last verified
- Aug 2019
- First submitted
- 27 Apr 2018
- Last updated
- 13 Aug 2019
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utility of a Supraaponeurotic Mesh as Prophylaxis of the Midline Eventration After an Oncological Colorrectal Resection
- ClinicalTrials.gov ID
- NCT03520465
- Acronym / sponsor ID
- PEACE
- Conditions
- Eventration
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 154 participants (estimated)
- Lead sponsor
- Instituto de Investigacion Sanitaria La FeUniversity, hospital or other
- Study start
- 27 Jun 2016 (actual)
- Primary completion
- Jun 2020 (estimated)
- Study completion
- Jun 2020 (estimated)
- First posted
- 9 May 2018 (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.
Randomized prospective experimental study, in which the effect of a prophylactic mesh is assessed in the eventration rate diagnosed by CT at one year after surgery in patients with CRC who underwent elective intervention for supra-infraumbilical midline laparotomy, considering as treatment the supra-aponeurotic mesh positioning (experimental group), and comparing it to the standard closing with a continuous suture using slow absorption monofilament.
Detailed description
Randomized prospective experimental study, in which we evaluate patients with CRC who underwent elective intervention for supra-infraumbilical midline laparotomy in order to:
Main objective:
- To assess the effect of the prophylactic mesh in the eventration rate diagnosed by CT at one year after surgery in patients with CRC who underwent elective intervention for supra-infraumbilical midline laparotomy.
Secondary objectives:
- To compare the appearance of complications in the control group and in the experimental group.
- Compare costs derived from short and long-term mesh placement in both groups.
We consider as treatment the supra-aponeurotic mesh positioning (experimental group), and compare it to the standard closing with slow absorption monofilament.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Supraaponeurotic mesh | Experimental | Device: DynaMesh®-CICAT longitudinal measure 10x35 cmPatients with laparotomy closure by conventional approach of aponeurosis (continuous suture with monofilament of slow absorption), and posterior placement of supraaponeurotic mesh of polyvinylidene fluoride (PVDF) medium / low density and wide pore. The mesh has a longitudinal measurement that exceeds about 3 cm the upper and lower ends of the wound and width should not be less than 10 cm, therefore the mesh selected is DynaMesh®-CICAT longitudinal measure 10x35 cm. The mesh is fixed to the aponeurosis with a crown of loose stitches and points to the midline. A prolene 2/0 non-reabsorbable monofilament suture of cylindrical needle is used. A 10 Fr suction drainage is placed in the supraaponeurotic plane, with an exit to the exterior beyond the edges of the prosthesis. Drainage will be preserved for a minimum of 48 hours after surgery, and will be withdrawn when a debit of less than 50 ml is presented in 24 h. |
| Monofilament | No intervention | –Patients with conventional closure of the middle laparotomy with approach of aponeurosis in a plane by continuous suture with monofilament of slow absorption. In this study, the suture used in all patients will be poly-4-hydroxybutyrate or Mono-max loop®. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Elective surgery for colorectal cancer.
- Surgery by middle laparotomy.
- Informed consent signed by the patient.
- Age > 18 years.
Key exclusion criteria (4 listed)
- Midline hernia or eventration.
- Presence of mesh in the abdominal wall because of a previous surgery.
- Palliative surgery.
- Synchronous metastases (Stage IV cancer according to TNM).
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 |
|---|---|---|
| DynaMesh®-CICAT longitudinal measure 10x35 cm | Device | Supraaponeurotic mesh |
Primary outcome
Eventration rate
Time frame: 1 year
To assess the effect of the prophylactic mesh in the eventration rate diagnosed by CT at one year after surgery in patients with CRC who underwent elective intervention for supra-infraumbilical midline laparotomy.
2 secondary outcomes
Complications rate
Time frame: 1 year
Short and long term derived costs
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2019.
- 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.
Matteo Frasson principal investigator
Instituto de Investigación Sanitaria La Fe
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DynaMesh®-CICAT longitudinal measure 10x35 cm in people with Eventration, run by Instituto de Investigacion Sanitaria La Fe at 1 site 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 4 inclusion and 4 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 13 Aug 2019. 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 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 Laura Segura (0034961246711, investigacion_clinica@iislafe.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eventration rate (time frame: 1 year). 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 13 Aug 2019.