Clinical trial: NCT06335550
Section: Alternatives
Subsections: What Is Not Standard Care Or Is Experimental In This Study|Potential Benefits|Alternative Procedures/ Treatments If You Do Not Participate In The Study

The study is being conducted because robotic mastectomy is not yet proven to be a standard surgical treatment in patients with breast cancer / tumours. We hope that your participation will help us to determine whether robotic mastectomy is equal or superior to existing conventional mastectomy.

If you participate in this study, you may reasonably expect to benefit from the robotic surgery in the following way:  
Smaller incision which may translate to lesser pain and faster recovery Improved satisfaction due to lesser pain and faster recovery Better aesthetic outcome

If you choose not to take part in this study, the alternative is to have what is considered standard care for your condition. In our institution, this would be conventional or endoscopic mastectomy.  
The advantage of standard care or endoscopic mastectomy would be a shorter duration of surgery (approximately 0.5-1.5hr shorter). The disadvantage would include a longer and scar, longer recovery period (approximately 1-2 weeks longer) and pain as a result of the longer incision required.
Clinical trial: NCT06335550
Section: Confidentiality
Subsections: Confidentiality Of Study And Medical Records

Your participation in this study will involve the collection of Personal Data. "Personal Data" means data about you which makes you identifiable (i) from such data or (ii) from that data and other information which an organisation has or likely to have access. Examples of personal data include name, national registration identity card (NRIC), nationality, passport information, date of birth, and telephone number.  
Personal Data collected for this study will be kept confidential. Your study records and medical records, to the extent required by the applicable laws and regulations, will not be made publicly available. Only the study team will have access to the personal data being collected from you.  
In the event of any publication regarding this study, your identity will remain confidential. However, the monitor(s), the auditor(s), the Institutional Review Board, and the regulatory authority(ies) will be granted direct access to your original medical records and study records to verify study procedures and data, without making any of your information public.  
By signing the Consent Form, you consent to (i) the collection, access to, use and storage of your Personal Data by Changi General Hospital, and (ii) the disclosure of such Personal Data to our authorised service providers and relevant third parties as mentioned above.  
Any information containing your Personal Data that is collected for the purposes of this research will be stored in Singapore. To protect your identity, your Personal Data will be labelled with a unique code number. The code will be used in place of your name and other information that directly and easily identifies you. The study team will keep a separate file that links your code number to your Personal Data. This will be kept in a safe place with restricted access.  
All data collected in this study are the property of Changi General Hospital. The data will be used for the purpose of this research study only, unless you give permission for your data to be made available for future use in other research studies. For this purpose, consent for future research will be sought from you. By participating in this research study, you are confirming that you have read, understood and consent to the SingHealth Data Protection Policy, the full version of which is available at www.singhealth.com.sg/pdpa.
Clinical trial: NCT06335550
Section: Duration of Study Involvement
Subsections: Visit 2 (Day Of Surgery):|Visit 3 (1 Month Post Operation Follow Up):|Visit 4 (6 Months Post Operation Follow Up):

You will undergo robotic mastectomy as per planned. There will be virtual/remote supervision from Dr Mok's mentor (from Taiwan) during the surgery. The study will be using the Da Vinci Xi surgical system and Dr Mok's surgical experiences are mainly using the Da Vinci Si surgical system. The difference between Da Vinci Si and Da Vinci Xi is that Da Vinci Xi is an improved  
  
version of Da Vinci Si as the Xi system features smaller, thinner robotic arms with redesigned joints that enable greater range of motion. Potentially this may result in shorter operating time with Da Vinci Xi system due to shorter docking time as well as easier manoeuvrability.  
You will be monitored in 23-hour ward as part of the routine clinical management and be discharge on Day 1 if you are well. Data (such as duration, pain medication usage) in relation to your surgery will be collected. During the robotic mastectomy, the breast is removed through a small incision with a robotic camera and small instruments attached to a robotic arm that is controlled by the surgeon at a computer console. A smaller incision is created on the side of the chest wall in comparison to the conventional mastectomy. Please refer to the figures below for the differences in the incision made for conventional mastectomy versus robotic mastectomy.  
Fig 1: Conventional Mastectomy  
  
  
  
without Reconstruction Fig 2: Robotic Mastectomy without Reconstruction Fig 3: Conventional Mastectomy  
  
  
With Reconstruction Fig 4: Robotic Mastectomy with Reconstruction Fig 5: Types of incision used in Conventional Mastectomy  
  
  
Fig 6: Types of incision used in Robotic  
  
Mastectomy

You will be follow up by your surgeon as part of routine clinical management. You will be required to complete questionnaires, to assess for change in your quality of life. This should not take more than 15 minutes.

You will be required to complete questionnaires, to assess for change in your quality of life. This may be done remotely via phone. This should not take more than 15 minutes.  
There will not be any additional study visits or blood investigations required. Data will only be collected from the medical records. Details of scheduled are as per tabulated below.  
| collected from the medical records. Details of scheduled are as per tabulated below. Visit 1 Visit 2 Visit 3 (+/-2  weeks)  Visit 4 (+/-2  Weeks) (Day of  Surgery) (Screening) (30th POD) (6 months  POD) Consent taking X Eligibility Check X Adverse Event Assessment X X X Clinical Assessment X X Collection of medical  X information X X X   |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|  
As part of standard care, you will be followed up as per conventional surgery. This includes twice weekly review of wound by the breast surgeon/ breast care nurses, with the earliest visit scheduled on post-operative day 4 and to continue until wound(s) have completely healed.  
If you agree to participate in this study, you should follow the advice and directions given to you by the study team.
Clinical trial: NCT06335550
Section: Participant's Rights
Subsections: Participant'S Rights

Your participation in this study is entirely voluntary. You have a right to ask questions, which the study team will do their best to answer clearly and to your satisfaction.  
In the event of any new information becoming available that may be relevant to your willingness to continue in this study, you (or your legal representative, if relevant) will be informed in a timely manner by the Principal Investigator or his/her representative and will be contacted for further consent if required.
Clinical trial: NCT06335550
Section: Possible Risks, Discomforts, and Inconveniences
Subsections: Possible Risks, Discomforts Or Inconveniences Personal Privacy And Confidentiality:|Post-Surgical Pain (13-21%):|Post-Surgical Bleeding / Haematoma (2.5 -5%):|Wound Infection / Abscess (5-8.1%)|Wound Breakdown And / Or Necrosis (0.5-7.2%)|Scar And Keloid Formation (1-3.8%)|Seroma (Build-Up Of Body Fluid) (2.5-51%)|Shoulder Stiffness (2-11%)|Numbness (11-28%)|Size Discrepancy (2-20%)|Asymmetry (1-20%)|Implant Migration (2-7%)|Implant Rupture (1.1 -17.7%)|Capsule Formation And Contracture (5-10.6%)|Prolonged Anaesthesia|Failure In Robotic Mastectomy (2-5%)|Research Related Injury And Compensation

This study uses health information that may affect your privacy. To protect your confidentiality, only a unique code number will be used to identify data that we collected from you. As there will be a link between the code and your identifiable information, there is still a possibility of data breach. A data breach is when someone sees or uses data without permission. If there is a data breach, someone could see or use the data we have about you.  
Even without your name, there is a chance someone could figure out who you are. They could misuse your data. We believe the chance of this is very small, but it is not zero.  
Risks as informed below, are similar between standard of care surgery and robotic mastectomy

When the anaesthesia wears off, you may experience some pain at the wound site. In anticipation of this, analgesia (pain medication) will be made available should you require it. The pain is usually more severe immediately after surgery and during the first few days post-surgery.  
You are encouraged to move the arm that is on the same side of the operation immediately after surgery, within the limits of your pain tolerance.  
This is to facilitate your shoulder movement and minimise shoulder tightness and stiffness.

This usually occurs because small blood vessels may reopen after surgery, or because the blood did not clot fast enough. This complication is more common in elderly patients, patients with bleeding tendencies or patients who are taking certain medications such as blood thinners.  
It may present as skin bruising or an accumulation of blood clot (haematoma) in the wound.  
In most cases, it is self-limiting and will resolve on its own. However, in some cases of more serious bleeding, surgery may be necessary to stop the bleeding and wash out the blood clot. A blood transfusion may also be necessary. Your doctor will assess and advise you accordingly.

As with most surgeries, the risk of wound infection will be present, although all precautions will be taken to minimise it. The risk of wound infection is higher for patients who are elderly, have diabetes, smoke or are taking certain medications such as steroids.  
After discharge, you will be monitored for wound infection. In mild cases of infection, cleaning the wound and / or antibiotics may be required.  
In severe cases of infection, pus may accumulate in the wound (abscess), which may require removal by needle aspiration or surgery.  
Your doctor will assess and advise you accordingly.

The surgical wound may heal poorly, exhibit gaping or breakdown and/or the wound edge may turn black due to a lack of blood supply.  
Patients who are elderly, have diabetes, smoke or are taking certain medications such as steroids, may be more prone to wound breakdown and necrosis.  
In mild cases, it may be managed by daily dressing. In more severe cases, a special type of dressing called Vacuum-Assisted Closure (VAC) dressing may be required. In certain cases, surgery may be needed to remove the unhealthy skin.  
Your doctor will assess and advise you accordingly.

The incision will heal with the formation of a scar. In most patients, the scar will become less obvious with time.  
However, some patients are prone to keloid formation (raised scars). This is largely dependent on the patient's personal healing capacity.  
If you are prone to keloids, there is a cream which may be applied to the wound once it has healed to minimise the keloid formation. Please let your doctor know if you are prone to keloids.

In most cases, the drain used to collect the seroma may be removed after 1-2 weeks.  
However, some patients may require the drain to be kept in longer.  
You may experience some discomfort at the site of the drain.  
Seroma may also accumulate after the drain has been removed.  
If the amount is small, your body will re-absorb the fluid naturally.  
If the volume is large, a needle aspiration (insertion of a needle into the fluid collection to draw out the fluid) may be required.  
However, the fluid may re-accumulate and repeated needle aspiration of the fluid may be required.  
A seroma may also get infected. Antibiotics, needle aspirations and surgery may then be needed.  
Your doctor will assess and advise you accordingly.

You may experience some stiffness and/or tightness in the shoulder on the side of your surgery.  
This is usually due to the pain and swelling which may occur after surgery. Early movement and stretching of the shoulder will help to minimise and possibly avoid future shoulder stiffness and restricted movement.  
Moving the arm on the side of the surgery will not cause injury to the wound and therefore, you are encouraged to start moving your arm as soon as possible after the surgery, within the limits of your pain tolerance.

The skin over the chest will be numb after a mastectomy as the nerves to the skin over the breast have been cut during the mastectomy.  
The numbness may lessen with time, but full recovery of sensation is unlikely to occur.
For participants undergoing reconstruction, the following may applies:

Although implants are available in a variety of shapes and sizes, it is not customized to you. Hence it may not be an exact match of your breast shape and/or size.  
Moreover, as the implant shape and size is fixed, it will not increase or decrease in size should there be subsequent weight loss or weight gain after the surgery.  
Your doctor will assess your condition and advise you accordingly.

During surgery, the implant is placed in the position to match your other breast when you are wearing a bra.  
The implant will not droop like the other breast.  
Therefore, symmetry may only be achieved when you are wearing a bra.

The position of the implant may shift / move (migration). If it is minimal and not noticeable, it can be left alone.  
However, if the position is unacceptable, surgery may be required to re-position it.

With time, the implant may break, especially if a large force is exerted on it.  
Should this happen, the implant may need to be removed surgically.

Your body will react to the implant by forming a fibrous layer around the implant, wrapping it in a "capsule" (capsule formation).  
This helps to protect the implant from infection and migration. Should there be a break in the implant (rupture), the capsule also keeps the material of the implant contained.  
However, in some individuals, the capsule may thicken and harden (contracture) with time, causing distortion and discomfort. This may then require surgery to release the capsule.  
Should this happen, your doctor will assess your condition and advise you accordingly.

As the robotic surgery will be estimated to be 0.5-1.5hour than conventional mastectomy, you will be placed under GA for a longer period.  
The side effect of prolonged anaesthesia includes but is not limited to nausea and vomiting, sore throat or hoarseness, difficulty with urination, post-operative infection etc. You will be monitored for side effect during your stay.

In the event robotic mastectomy is not successful, the surgery may be completed using conventional/ endoscopic surgery. The risks of conversion is between 2-5% based on current reported series in the literatures.
The possible risks, discomfort or inconveniences of endoscopic mastectomy are similar to conventional mastectomy and robotic mastectomy.

If you follow the directions of the Principal Investigator of this research study and you are injured due to the research procedure given under the plan for the research study, our institution will provide you with the appropriate medical treatment. Payment for management of the normally expected consequences of your treatment (i.e.  
consequences of your treatment which are not caused by your participation in the research study) will not be provided. You still have all your legal rights. Nothing said here about treatment or compensation in any way alters your right to recover damages where you can prove negligence.
Clinical trial: NCT06335550
Section: Procedures
Subsections: Study Procedures & Your Responsibilities In This Study|Schedule Of Visit Appointments And Research Study Procedures: Visit 1 (Screening):

If you agree to take part in this study, you will be asked to undergo robotic mastectomy.  
Your participation in the study will last till 6 month post-operatively. You will need to visit the doctor's office 3 times in the course of the study (Visit 1-Visit 3).

You will be assessed to determine if you are suitable to participate in the study. If you do consent to participate, data will be collected with regards to your demographics, general health, biochemical and radiological tests. This will be done for tests that you may have done before, and data will continue to be collected until your involvement in the study has been completed. You will be required to complete questionnaires to look at your quality of life. This should not take more than 15 minutes.
Clinical trial: NCT06335550
Section: Purpose of Research
Subsections: Purpose Of The Research Study

The purpose of this study is to whether robotic mastectomy is a safe surgical alternative in comparison to conventional mastectomy. Robotic mastectomy is performed in a few countries/centres worldwide (Taiwan, South Korea, Japan, China, France, Italy), there are no cases performed in Singapore. Dr Mok Chi Wei, Principal Investigator is the first and only trained surgeon in Singapore/South East Asia to perform robotic mastectomy. He was trained in Taiwan in year 2019. We hope to learn whether robotic mastectomy offer better aesthetic outcome, faster recovery time and improve patient's satisfaction.  
You were selected as a possible participant in this study because you have been known to have a tumour and will be undergoing mastectomy with or without axillary dissection, implant reconstruction, flap construction as per discussion with your attending surgeon.  
This study targets to recruit 20 participants from Changi General Hospital.
Clinical trial: NCT06335550
Section: Withdrawal from Study
Subsections: Withdrawal From Study

You are free to withdraw your consent and discontinue your participation in the study at any time, without your medical care being affected. If you decide to stop taking part in this study, you should tell the Principal Investigator.  
If you withdraw from the study, You will still be required to follow up as per routine clinical practice.
However, any of your data that has been collected until the time of your withdrawal will be kept and analysed. The reason is to enable a complete and comprehensive evaluation of the study. Your study doctor, the Principal Investigator of this study may stop your participation in the study at any time for one or more of the following reasons:  
Failure to follow the instructions of the Principal Investigator and/or study staff. The Principal Investigator decides that continuing your participation could be harmful to your health or safety.  
Pregnancy The study is cancelled.