Periareolar Minimally Invasive Cardiac SurgeryPAMINCT04726488
Periareolar Approach in Minimally Invasive Cardiac Surgery
A study testing Periareolar Approach in Minimally Invasive Cardiac Surgery (PAMI Technique) and inframammary approach in people with Periareolar Minimally Invasive Cardiac Surgery, run by Assiut University.
Trial summary
Overall Goal: To study the feasibility and safety of "periareolar minimally invasive surgery" protocol in patients undergoing periareolar minimally invasive surgery vs. Control group (inframammary approach). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Periareolar Minimally Invasive Cardiac Surgery
- What is being tested?
- Periareolar Approach in Minimally Invasive Cardiac Surgery (PAMI Technique) and inframammary approach
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- No sites listed yet
- Study dates
- Feb 2021to Feb 2023
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients undergoes mitral or tricuspid valve surgery.
- lesion of right side of the heart.
Who cannot join
- patients undergoing aortic valve or CABG surgery.
- surgery of left side of the heart.
About this study
Official title: Periareolar Approach in Minimally Invasive Cardiac Surgery; New Trend.
Overall Goal: To study the feasibility and safety of "periareolar minimally invasive surgery" protocol in patients undergoing periareolar minimally invasive surgery vs. Control group (inframammary approach).
- Objective1: Test the hypothesis that, the periareolar approach is more feasible and safer than the inframammary approach.
- Objective2: Identify risk factors that are predictive of the need for periareolar approach.
- Objective3: Assess outcomes and postoperative results of both periareolar and inframammary approach.
Read the detailed description
The first successful cardiac operation was performed in 1896, in Germany by Rehn (1), followed by the first successful cardiac valve operation in 1912 by Tuffier (2) and the first successful mitral valve operation in 1923 (3).
In 1956, Lillehei repaired multiple valvular lesions through a right thoracotomy using cardiopulmonary bypass (4).
In the 1990s, the success of laparoscopic operations in general surgery renewed an interest in minimally invasive approaches for cardiac surgery. Navia and Cosgrove (5) and Cohn et al. (6) performed the first minimally invasive valve operations via the right parasternal and transsternal approaches. Remarkably, excellent exposure was achieved through smaller incisions, thereby making complex valve repair possible and safe.
In 1996, Carpentier et al. (7) performed the first video-assisted mitral valve repair through a minithoracotomy using ventricular fibrillation. With more experience, video-assisted, 2-dimensional endoscopes and robotics were introduced by Carpentier (7) and Chitwood (8,9).
In 2009 Poffo et al (10,11) describe a new technique of minimally invasive cardiac surgery. He and his colleagues adopting periareolar access for mitral valve surgery since 2006 and published this technique in 2009.
However, due to its feasibility and safety, was soon incorporated as an ideal access for other cardiac pathologies such as tricuspid valve disease, atrial septal defect, atrial fibrillation, and pacemaker leads endocarditis. This led Poffo and his colleagues to publish a long-term result on his technique in 2018 supporting the use of periareolar access as a routine surgical technique for correction of several cardiac pathologies, especially in women. (12)
- Being tested
- Periareolar Approach in Minimally Invasive Cardiac Surgery (PAMI Technique), inframammary approach
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Periareolar Approach in Minimally Invasive Cardiac Surgery (PAMI Technique)Procedure or surgery
To study the feasibility and safety of "periareolar minimally invasive surgery" protocol in patients undergoing periareolar minimally invasive surgery vs. Control group (inframammary approach).
inframammary approachProcedure or surgery
To study the feasibility and safety of "periareolar minimally invasive surgery" protocol in patients undergoing periareolar minimally invasive surgery vs. Control group (inframammary approach).
| Study group | Role | What they receive |
|---|---|---|
| Periareolar Approach | Experimental | To study the feasibility and safety of "periareolar minimally invasive surgery" protocol in patients undergoing periareolar minimally invasive surgery vs. Control group (inframammary approach). Receives: Procedure: Periareolar Approach in Minimally Invasive Cardiac Surgery (PAMI Technique) |
| Inframammary Approach | Active comparator | To study the feasibility and safety of "periareolar minimally invasive surgery" protocol in patients undergoing periareolar minimally invasive surgery vs. Control group (inframammary approach). Receives: Procedure: inframammary approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of surgery
start from skin incision to cardiopulmonary bypass initiation
Measured: 2 hours
Secondary outcomes (1)
rate of surgical site complications
wound infection, dehiscence, seroma
Measured: three month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2021
- Study startFeb 2021 (estimated)
- Primary completionSep 2022 (estimated)
- Study completionFeb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periareolar Minimally Invasive Cardiac SurgeryStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed El Adel Sayed Hassanein Sayed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04726488
- Sponsor's protocol ID
- Periareolar Minimally Invasive
- Acronym
- PAMI
- Status last verified
- Jan 2021
- First submitted
- 24 Jan 2021
- Last updated
- 27 Jan 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Periareolar Approach in Minimally Invasive Cardiac Surgery; New Trend.
- ClinicalTrials.gov ID
- NCT04726488
- Acronym / sponsor ID
- PAMI / Periareolar Minimally Invasive
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Feb 2021 (estimated)
- Primary completion
- Sep 2022 (estimated)
- Study completion
- Feb 2023 (estimated)
- First posted
- 27 Jan 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.
Overall Goal: To study the feasibility and safety of "periareolar minimally invasive surgery" protocol in patients undergoing periareolar minimally invasive surgery vs. Control group (inframammary approach).
- Objective1: Test the hypothesis that, the periareolar approach is more feasible and safer than the inframammary approach.
- Objective2: Identify risk factors that are predictive of the need for periareolar approach.
- Objective3: Assess outcomes and postoperative results of both periareolar and inframammary approach.
Detailed description
The first successful cardiac operation was performed in 1896, in Germany by Rehn (1), followed by the first successful cardiac valve operation in 1912 by Tuffier (2) and the first successful mitral valve operation in 1923 (3).
In 1956, Lillehei repaired multiple valvular lesions through a right thoracotomy using cardiopulmonary bypass (4).
In the 1990s, the success of laparoscopic operations in general surgery renewed an interest in minimally invasive approaches for cardiac surgery. Navia and Cosgrove (5) and Cohn et al. (6) performed the first minimally invasive valve operations via the right parasternal and transsternal approaches. Remarkably, excellent exposure was achieved through smaller incisions, thereby making complex valve repair possible and safe.
In 1996, Carpentier et al. (7) performed the first video-assisted mitral valve repair through a minithoracotomy using ventricular fibrillation. With more experience, video-assisted, 2-dimensional endoscopes and robotics were introduced by Carpentier (7) and Chitwood (8,9).
In 2009 Poffo et al (10,11) describe a new technique of minimally invasive cardiac surgery. He and his colleagues adopting periareolar access for mitral valve surgery since 2006 and published this technique in 2009.
However, due to its feasibility and safety, was soon incorporated as an ideal access for other cardiac pathologies such as tricuspid valve disease, atrial septal defect, atrial fibrillation, and pacemaker leads endocarditis. This led Poffo and his colleagues to publish a long-term result on his technique in 2018 supporting the use of periareolar access as a routine surgical technique for correction of several cardiac pathologies, especially in women. (12)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Periareolar Approach | Experimental | Procedure: Periareolar Approach in Minimally Invasive Cardiac Surgery (PAMI Technique)To study the feasibility and safety of "periareolar minimally invasive surgery" protocol in patients undergoing periareolar minimally invasive surgery vs. Control group (inframammary approach). |
| Inframammary Approach | Active comparator | Procedure: inframammary approachTo study the feasibility and safety of "periareolar minimally invasive surgery" protocol in patients undergoing periareolar minimally invasive surgery vs. Control group (inframammary approach). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients undergoes mitral or tricuspid valve surgery.
- lesion of right side of the heart.
Key exclusion criteria (2 listed)
- patients undergoing aortic valve or CABG surgery.
- surgery of left side of the heart.
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 |
|---|---|---|
| Periareolar Approach in Minimally Invasive Cardiac Surgery (PAMI Technique)To study the feasibility and safety of "periareolar minimally invasive surgery" protocol in patients undergoing periareolar minimally invasive surgery vs. Control group (inframammary approach). | Procedure or surgery | Periareolar Approach |
| inframammary approachTo study the feasibility and safety of "periareolar minimally invasive surgery" protocol in patients undergoing periareolar minimally invasive surgery vs. Control group (inframammary approach). | Procedure or surgery | Inframammary Approach |
Primary outcome
Duration of surgery
Time frame: 2 hours
start from skin incision to cardiopulmonary bypass initiation
1 secondary outcome
rate of surgical site complications
Time frame: three month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2021.
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?
A study testing Periareolar Approach in Minimally Invasive Cardiac Surgery (PAMI Technique) and inframammary approach in people with Periareolar Minimally Invasive Cardiac Surgery, run by Assiut University.
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 2 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 27 Jan 2021. 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?
Results are not available in the source record.
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?
Duration of surgery (time frame: 2 hours). 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 27 Jan 2021.