Closure of Abdominal WallPHACPANCT02658955
Changing Technique of Abdominal Wall Closure (PHACPA)
A study testing Short stitch in people with Closure of Abdominal Wall, run by Hospital del Mar at 1 site in Spain.
Trial summary
Implementing guidelines of EHS for abdominal wall closure in all specialities of a General Hospital. Migrating from large stitch technique to short stitch technique. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Closure of Abdominal Wall
- What is being tested?
- Short stitch
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,164 participants
- Where
- 1 siteSpain
- Study dates
- Jun 2016to Jul 2018
- 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 operated on by laparotomy
Who cannot join
- Previous mesh
- Concomitant hernia repair
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Changing Technique of Abdominal Wall Closure According to European Hernia Society (EHS) Guidelines in a General Hospital
Implementing guidelines of EHS for abdominal wall closure in all specialities of a General Hospital. Migrating from large stitch technique to short stitch technique.
Read the detailed description
Surgeons will receive instruction about new techniques of closure of the abdomen and will practice in models and receive a certification previously to implement in their surgical practice the new technique.
Results will be monitorised and compared with previous cohort of patients. A protocol of closure will be implemented. Patients without risk factors will receive a laparotomy closure with "short stitch" technique and patients with risk factor for developing incisional hernia or burst abdomen and aditional profilactic suprafascial mesh.
- Conditions
- Closure of Abdominal Wall
- Being tested
- Short stitch
- Keywords
- Abdominal wall closure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Short stitchProcedure or surgery
Surgeons will receive instructions to change the technique of abdominal wall closure
| Study group | Role | What they receive |
|---|---|---|
| Short stitch | Experimental | Patients in which abdominal wall is closed by short stitch technique Receives: Procedure: Short stitch |
| Large stitch | No intervention | Patients who didn't receive properly closure according with the protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incisional hernia and burst abdomen rate
Analysis of the number of incisional hernia and burst abdomen after one year follow-up
Measured: One year
Secondary outcomes (3)
Rate of fulfillment of the protocol
Analysis of results related with the fulfillment of the protocol
Measured: One year
Complication rate
Analysis of complications related with the closure technique
Measured: One month
Mesh complications rate
Analysis of mesh related complications in patients with a prophylactic mesh
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2016 (estimated)
- Study startJun 2016
- Primary completionJul 2018
- Study completionJul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Closure of Abdominal WallStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,164 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital del Mar
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, José A. Pereira, Hospital del Mar
- Investigators
- José A. Pereira, MD, Principal investigator, Surgeon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02658955
- Sponsor's protocol ID
- HMar
- Acronym
- PHACPA
- Status last verified
- Oct 2019
- First submitted
- 14 Jan 2016
- Last updated
- 10 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changing Technique of Abdominal Wall Closure According to European Hernia Society (EHS) Guidelines in a General Hospital
- ClinicalTrials.gov ID
- NCT02658955
- Acronym / sponsor ID
- PHACPA / HMar
- Conditions
- Closure of Abdominal Wall
- Keywords
- Abdominal wall closure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,164 participants (actual)
- Lead sponsor
- Hospital del MarUniversity, hospital or other
- Study start
- Jun 2016 (actual)
- Primary completion
- Jul 2018 (actual)
- Study completion
- Jul 2018 (actual)
- First posted
- 20 Jan 2016 (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.
Implementing guidelines of EHS for abdominal wall closure in all specialities of a General Hospital. Migrating from large stitch technique to short stitch technique.
Detailed description
Surgeons will receive instruction about new techniques of closure of the abdomen and will practice in models and receive a certification previously to implement in their surgical practice the new technique.
Results will be monitorised and compared with previous cohort of patients. A protocol of closure will be implemented. Patients without risk factors will receive a laparotomy closure with "short stitch" technique and patients with risk factor for developing incisional hernia or burst abdomen and aditional profilactic suprafascial mesh.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Short stitch | Experimental | Procedure: Short stitchPatients in which abdominal wall is closed by short stitch technique |
| Large stitch | No intervention | –Patients who didn't receive properly closure according with the protocol |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients operated on by laparotomy
Key exclusion criteria (2 listed)
- Previous mesh
- Concomitant hernia repair
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 |
|---|---|---|
| Short stitchSurgeons will receive instructions to change the technique of abdominal wall closure | Procedure or surgery | Short stitch |
Primary outcome
Incisional hernia and burst abdomen rate
Time frame: One year
Analysis of the number of incisional hernia and burst abdomen after one year follow-up
3 secondary outcomes
Rate of fulfillment of the protocol
Time frame: One year
Complication rate
Time frame: One month
Mesh complications rate
Time frame: One year
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 10 Oct 2019.
- Individual participant dataSharing planned: No
Related trials for Closure of Abdominal Wall
Recruiting
Standard Closure vs. Integrated Mesh-Fascial Closure (IMFC) for Incisional Hernia Repair
Incisional Hernia Repair, Ventral Incisional Hernia
Not yet recruiting
Phasix Mesh Underlay During Loop Ileostomy Closure
Incisional Hernia of Anterior Abdominal Wall
Recruiting
Compliance-Guided Abdominal Wall Closure Strategy in Large Ventral Hernia Repair
Hernia, Ventral, Hernia Incisional
Not yet recruiting
Synthetic Mesh for Prevention of HernIa After opEn Abdomen cLosure stuDy
Open Abdomen, Incisional Hernia
Not yet recruiting
Vacuum-Assisted Closure Versus Graduated Primary Skin Closure for Postoperative Burst Abdomen
Abdominal Wound Dehiscence, Burst Abdomen
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.
José A. Pereira, MD principal investigator
Surgeon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Short stitch in people with Closure of Abdominal Wall, 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 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: finished, as of the sponsor's last update on 10 Oct 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?
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 and burst abdomen rate (time frame: One 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 10 Oct 2019.