Prevention of Incisional Hernia in Emergency SurgeryNCT04578561
Long-term Follow-up of Prophylactic Mesh Reinforcement After Emergency Laparotomy.
An observational study of Prevention of Incisional Hernia in Emergency Surgery, run by José A. Pereira.
Trial summary
Observational Study analyzing the long-term results of prophylactic mesh used for preventing incisional hernia after emergency midline laparotomies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prevention of Incisional Hernia in Emergency Surgery
- What is being tested?
- Prophylactic mesh use
- Type of treatment
- Surgery or procedure
- How many people
- 187 participants
- Where
- No sites listed yet
- Study dates
- Jan 2010to Jan 2020
- Phase
- Observational
- 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
- Adult, Older adult
Study population: Patients who underwent emergency midline laparotomies in the period between January 2009 and July 2010 in our University Hospital. We included all consecutive patients. with at least 2 years of follow-up.
Who may be able to join
- Patients undergoing emergency midline laparotomy
Who cannot join
- Those with need of concomitant hernia repair.
- Those who received incisions outside the midline.
- Those with delayed abdominal closure.
- Those who died in the immediate postoperative period.
- Those without a minimum 2 years of follow-up.
About this study
Observational Study analyzing the long-term results of prophylactic mesh used for preventing incisional hernia after emergency midline laparotomies.
Read the detailed description
Background. Prevention of incisional hernias with a prophylactic mesh in emergency surgery is controversial. The present study aimed to analyze the long-term results of prophylactic mesh used for preventing incisional hernia after emergency midline laparotomies.
Methods. This study was a retrospective analysis of patients who underwent an emergency midline laparotomy between January 2009 and July 2010 with a follow-up period of longer than 2 years. Long-term outcomes and risk factors for the development of incisional hernias between patients who received a prophylactic reinforcement mesh (Group M) and suture (Group S) were compared.
- Being tested
- Prophylactic mesh use
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prophylactic mesh useProcedure or surgery
Also called Incisional hernia prevention
After laparotomy sutured clousur the abdominal wall wound is reinforced using a suprafascial synthetic mesh.
| Study group | Role | What they receive |
|---|---|---|
| Prophylactic mesh | Patients who received a prophylactic mesh after emergency surgery due to high risk of incisional hernia. Receives: Procedure: Prophylactic mesh use | |
| Suture | Patients who's laparotomies closure was using only suture without any abdominal wall reinforcement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incisional hernia
Detection of clinical or subclinical incisional hernia during postoperative longterm followup
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2020
- Study startJan 2010
- Primary completionJan 2019
- Study completionJan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prevention of Incisional Hernia in Emergency SurgeryStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 187 participants (actual)
Sponsor and investigators
- Lead sponsor
- José A. Pereira
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, José A. Pereira, Hospital del Mar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04578561
- Sponsor's protocol ID
- 20198240I
- Status last verified
- Oct 2020
- First submitted
- 5 Oct 2020
- Last updated
- 8 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bravo-Salva A, Argudo-Aguirre N, Gonzalez-Castillo AM, Membrilla-Fernandez E, Sancho-Insenser JJ, Grande-Posa L, Pera-Roman M, Pereira-Rodriguez JA. Long-term follow-up of prophylactic mesh reinforcement after emergency laparotomy. A retrospective controlled study. BMC Surg. 2021 May 18;21(1):243. doi: 10.1186/s12893-021-01243-x.
PubMed 34006282
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Follow-up of Prophylactic Mesh Reinforcement After Emergency Laparotomy.
- ClinicalTrials.gov ID
- NCT04578561
- Acronym / sponsor ID
- 20198240I
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 187 participants (actual)
- Lead sponsor
- José A. PereiraUniversity, hospital or other
- Study start
- Jan 2010 (actual)
- Primary completion
- Jan 2019 (actual)
- Study completion
- Jan 2020 (actual)
- First posted
- 8 Oct 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.
Observational Study analyzing the long-term results of prophylactic mesh used for preventing incisional hernia after emergency midline laparotomies.
Detailed description
Background. Prevention of incisional hernias with a prophylactic mesh in emergency surgery is controversial. The present study aimed to analyze the long-term results of prophylactic mesh used for preventing incisional hernia after emergency midline laparotomies.
Methods. This study was a retrospective analysis of patients who underwent an emergency midline laparotomy between January 2009 and July 2010 with a follow-up period of longer than 2 years. Long-term outcomes and risk factors for the development of incisional hernias between patients who received a prophylactic reinforcement mesh (Group M) and suture (Group S) were compared.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prophylactic mesh | – | Procedure: Prophylactic mesh usePatients who received a prophylactic mesh after emergency surgery due to high risk of incisional hernia. |
| Suture | – | –Patients who's laparotomies closure was using only suture without any abdominal wall reinforcement |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients who underwent emergency midline laparotomies in the period between January 2009 and July 2010 in our University Hospital. We included all consecutive patients. with at least 2 years of follow-up.
Key inclusion criteria (1 listed)
- Patients undergoing emergency midline laparotomy
Key exclusion criteria (5 listed)
- Those with need of concomitant hernia repair.
- Those who received incisions outside the midline.
- Those with delayed abdominal closure.
- Those who died in the immediate postoperative period.
- Those without a minimum 2 years of follow-up.
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 useAlso: Incisional hernia preventionAfter laparotomy sutured clousur the abdominal wall wound is reinforced using a suprafascial synthetic mesh. | Procedure or surgery | Prophylactic mesh |
Primary outcome
Incisional hernia
Time frame: 2 years
Detection of clinical or subclinical incisional hernia during postoperative longterm followup
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2020.
- Derived from this study: PubMed 34006282Bravo-Salva A, Argudo-Aguirre N, Gonzalez-Castillo AM, Membrilla-Fernandez E, Sancho-Insenser JJ, Grande-Posa L, Pera-Roman M, Pereira-Rodriguez JA. Long-term follow-up of prophylactic mesh reinforcement after emergency laparotomy. A retrospective controlled study. BMC Surg. 2021 May 18;21(1):243. doi: 10.1186/s12893-021-01243-x.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Prevention of Incisional Hernia in Emergency Surgery, run by José A. Pereira.
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 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: finished, as of the sponsor's last update on 8 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incisional hernia (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04578561, which also lists 1 linked publication.
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 8 Oct 2020.