Incisional Hernia of Midline of AbdomenNCT04808063
Algorithm for Prophylactic Mesh Use in Emergency Laparotomy.
A study testing Prophylactic mesh implantation in people with Incisional Hernia of Midline of Abdomen, run by Hospital del Mar at 1 site in Spain.
Trial summary
Use of informed algorithm for patients selection of prophylactic mesh aplication after midline laparotomy in emergency surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Incisional Hernia of Midline of Abdomen
- What is being tested?
- Prophylactic mesh implantation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2021to 31 Dec 2022
- 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
- Emergency midline laparotomy.
Who cannot join
- Surgical infection present at the moment of surgery.
- Ventrla or incisional hernia present at the moment of laparotomy .
- Open abdomen.
- Preoperative American Society of Anesthesiologist score (ASA) of V.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital del Mar
Barcelona, Catalonia, 08911
Alejandro Bravo-Salva, M.D., +34932483204, abravo@psmar.cat
About this study
Official title: Prevention of Incisional Hernia in Emergent Laparotomy Using a Prophylactic Mesh Augmentation Protocol Algorithm.
Use of informed algorithm for patients selection of prophylactic mesh aplication after midline laparotomy in emergency surgery.
Read the detailed description
Midline laparotomy complications have a high rate. When midline laparotomy is performed complications rate is even higher. One of the commons complications is incisional hernia, reaching up to 40%- 50% of cases in High risk groups.
Prophylactic mesh use has been proved to be useful preventing midline laparotomy in elective surgery. Despite this, there is not enough data to recommend its use in emergency surgery.
Aim of the study is to investigate if use of an algorithm of informed decision for use of prophylactic mesh in emergency midline laparotomy reduces incisional hernia incidence.
Prospective cohort study of all consecutive midline laparotomy performed at our emergency surgery department. Compare correct application of algorithm outcomes versus non correct application.
- Conditions
- Incisional Hernia of Midline of Abdomen
- Being tested
- Prophylactic mesh implantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prophylactic mesh implantationProcedure or surgery
Use of an algorithm for prophylactic mesh implantation in high risk patients after emergency midline laparotomy.
| Study group | Role | What they receive |
|---|---|---|
| Algorithm use for prphylactic mesh after emergency laparotomy | Experimental | Patients with emergency surgery in whom algorithm for prophylactic mesh is use to help decide abdominal wall mesh reinforcement or not. Receives: Procedure: Prophylactic mesh implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incisional hernia
Diagnosis by clinical or image control of incicionsal hernia during follow up.
Measured: Durign first and second year of follow up
Secondary outcomes (2)
Incidence os surgical site ocurrence complications
Any surgical site ocurrence (SSO) complication will be registered and classified using Clavien-Dindo complication scale.
More common complications are:
- Seroma: a localized accumulation of serous fluid in a part of the body, occurring most commonly as a complication of a surgical procedure.
- Wound haemathoma: wound related swelling of blood.
- Surgical site infection: infection that occurs after surgery in the part of the body where the surgery took place. Will be classified as superficial or deep infection.
- Wound dehiscence: lack of cutaneous healing in surgical wound.
Measured: During first postoperative month.
Long term mesh related complications: chronic pain and mesh infection.
Chronic pain: is any pain which persists beyond the normal healing period of 12 weeks. Visual analoge scale will be used to measure it.
Mesh infection: Late-onset mesh infection is defined as acute inflammatory response in surgical area within months or years after operation. It is diagnosed by the presence of infection symptoms and imaging examinations.
Measured: During first year of follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2021
- Study start1 Jan 2021
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Incisional Hernia of Midline of AbdomenStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- Patients with emergency surgery using midline laparotomy
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital del Mar
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alejandro Bravo Salva, Hospital del Mar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04808063
- Sponsor's protocol ID
- CEIC2019/8240/I
- Status last verified
- Mar 2021
- First submitted
- 15 Mar 2021
- Last updated
- 19 Mar 2021
- 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 19 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Incisional Hernia in Emergent Laparotomy Using a Prophylactic Mesh Augmentation Protocol Algorithm.
- ClinicalTrials.gov ID
- NCT04808063
- Acronym / sponsor ID
- CEIC2019/8240/I
- Conditions
- Incisional Hernia of Midline of Abdomen
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hospital del MarUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 19 Mar 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.
Use of informed algorithm for patients selection of prophylactic mesh aplication after midline laparotomy in emergency surgery.
Detailed description
Midline laparotomy complications have a high rate. When midline laparotomy is performed complications rate is even higher. One of the commons complications is incisional hernia, reaching up to 40%- 50% of cases in High risk groups.
Prophylactic mesh use has been proved to be useful preventing midline laparotomy in elective surgery. Despite this, there is not enough data to recommend its use in emergency surgery.
Aim of the study is to investigate if use of an algorithm of informed decision for use of prophylactic mesh in emergency midline laparotomy reduces incisional hernia incidence.
Prospective cohort study of all consecutive midline laparotomy performed at our emergency surgery department. Compare correct application of algorithm outcomes versus non correct application.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Patients with emergency surgery using midline laparotomy
| Arm | Type | Receives |
|---|---|---|
| Algorithm use for prphylactic mesh after emergency laparotomy | Experimental | Procedure: Prophylactic mesh implantationPatients with emergency surgery in whom algorithm for prophylactic mesh is use to help decide abdominal wall mesh reinforcement or not. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Emergency midline laparotomy.
Key exclusion criteria (4 listed)
- Surgical infection present at the moment of surgery.
- Ventrla or incisional hernia present at the moment of laparotomy .
- Open abdomen.
- Preoperative American Society of Anesthesiologist score (ASA) of V.
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 |
|---|---|---|
| Prophylactic mesh implantationUse of an algorithm for prophylactic mesh implantation in high risk patients after emergency midline laparotomy. | Procedure or surgery | Algorithm use for prphylactic mesh after emergency laparotomy |
Primary outcome
Incisional hernia
Time frame: Durign first and second year of follow up
Diagnosis by clinical or image control of incicionsal hernia during follow up.
2 secondary outcomes
Incidence os surgical site ocurrence complications
Time frame: During first postoperative month.
Long term mesh related complications: chronic pain and mesh infection.
Time frame: During first year of follow-up.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2021.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prophylactic mesh implantation in people with Incisional Hernia of Midline of Abdomen, run by Hospital del Mar 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 1 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 19 Mar 2021. 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 Alejandro Bravo-Salva, M.D. (+34932483204, abravo@psmar.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incisional hernia (time frame: Durign first and second year of follow up). 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 19 Mar 2021.