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Robot vs. surgeon: which breast cancer surgery makes patients happier?

NCT ID NCT03440398

Symptom relief Sponsor: European Institute of Oncology Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study compared two types of nipple-sparing mastectomy for breast cancer: one done with a robot and the other with traditional open surgery. 82 women took part, and the main goal was to see which approach led to higher patient satisfaction. The trial also looked at recovery time and complications.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Robotic surgery procedure
What this could lead to
If successful, robotic surgery could offer better cosmetic results and shorter hospital stays for women needing mastectomy.
What could go wrong
This is a small, completed trial with 82 participants, so results may not apply to everyone. Robotic surgery also carries risks like infection or complications.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

82 people

The number who actually took part.

Started

Mar 2017

Finished

Feb 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Invasive breast cancer, Ductal Carcinoma In Situ, Breast Related Cancer Antigens mutation carriers. * Any age * Candidates to nipple-sparing mastectomy and immediate breast reconstruction * Negative preoperative assessment of nipple-areola complex * Absence of skin involvement * Low probability to have positivity of nipple-areola complex tissue intra-operative frozen section * Breast volume ≤ Bra IV; from cup A to D * No hard smoking (hard smoking defined as \>20 cigarettes/day) * Low and intermediate risk for anesthesia (ASA Scale) * Written informed consent must be signed and dated by the patient and the investigator prior to inclusion * Patients must be accessible for follow-up Exclusion criteria: * Previous thoracic radiation therapy for any reason * Inflammatory Breast Cancer * Skin involvement * Pre-operative diagnosis (radiological or cytological) of nipple-areola complex disease * Pregnancy * Patients with psychiatric, addictive, or any disorder, which compromises ability to give informed consent for participation in this study * Uncompensated Diabetes Mellitus * Hard smokers (hard smoking defined as \>20 cigarettes/day) * High risk for anesthesia

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm ductal breast carcinoma in situ invasive breast carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Breast cancer

Contacts and locations

Locations

  • European Institute of Oncology

    Milan, 20141, Italy

More trials for these conditions

Other studies related to the condition(s) this trial covers.