Early Breast CancerNCT01613352
Feasibility of Ambulatory Surgery for Early Breast Cancer
A study testing Ambulatory surgery in people with Early Breast Cancer and Psychosocial Wellbeing, run by Helsinki University Central Hospital at 1 site in Finland.
Trial summary
The aim was to assess the patient compliance and medical and psychosocial effects of same day hospital discharge after breast conserving surgery and sentinel node biopsy only. Read more about this study
- Who is it for?
- Ages 18 to 90 years, women only
- Conditions the study is for
- Early Breast Cancer, Psychosocial Wellbeing, Ambulatory Surgery
- What is being tested?
- Ambulatory surgery
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteFinland
- Study dates
- Mar 2008to Apr 2011
- 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 to 90 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Breast cancer < 2cm
- Clinically node negative
- ASA I-II
Who cannot join
- Axillary clearance performed
- ASA III-IV
- No adult companion at home
Trial locations and contacts
1 site in 1 country.
Finland1 site
Helsinki University Central Hospital, Jorvi Hospital
Espoo, HUS, 00029
About this study
Official title: Same Day Discharge After Surgery for Early Breast Cancer - a Feasible Option
The aim was to assess the patient compliance and medical and psychosocial effects of same day hospital discharge after breast conserving surgery and sentinel node biopsy only.
Read the detailed description
The patients with small breast tumours (<2 cm)and clinically node negative disease, were randomized to receive breast conserving surgery and sentinel node biopsy as ambulatory surgery or inpatient-surgery.Complication rate, patient satisfaction and psychosocial outcomes were compared. The psychosocial effects of the treatment mode on their spouses were recorded as well.
- Being tested
- Ambulatory surgery
- Keywords
- Early breast cancer surgery, Psychosocial wellbeing, Ambulatory surgery
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ambulatory surgeryOther
Sentinel node mapping was done on the previous day and the patients were operated on first in the morning.
| Study group | Role | What they receive |
|---|---|---|
| Day surgery group | Experimental | Patients who underwent breast conserving surgery and sentinel node biopsy only and were randomized to ambulatory surgery group. Receives: Other: Ambulatory surgery |
| In-Patient group | Active comparator | Patients who underwent breast conserving surgery and sentinel node biopsy only and were randomized to in-patient group. Receives: Other: Ambulatory surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psychosocial wellfare
Difference between the groups in questionnaire measuring anxiety and psychosocial wellfare
Measured: First postoperative day
Secondary outcomes (1)
Number of complications and return to hospital rate
The difference in the number of complications or return to the hospital rate between the groups
Measured: one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2012 (estimated)
- Study startMar 2008
- Primary completionApr 2011
- Study completionApr 2011
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 Early Breast CancerStudies of the same condition, open and under way.
- More trials run by Helsinki University Central HospitalThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helsinki University Central Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jaana Vironen, Helsinki University Central Hospital
- Investigators
- Jaana H Vironen, MD, PhD, Principal investigator, Helsinki University Central Hospital, Jorvi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01613352
- Sponsor's protocol ID
- 329 / E6 / 07
- Status last verified
- Jun 2012
- First submitted
- 5 Jun 2012
- Last updated
- 7 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Ojala K, Vironen JH, Mattila K, Eklund AM, Leidenius MH, Meretoja TJ. Feasibility of Day Surgery in Patients With Breast Conservation and Sentinel Node Biopsy: A Randomized Controlled Trial. Scand J Surg. 2016 Mar;105(1):29-34. doi: 10.1177/1457496915583201. Epub 2015 Apr 28.
PubMed 25922474
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Same Day Discharge After Surgery for Early Breast Cancer - a Feasible Option
- ClinicalTrials.gov ID
- NCT01613352
- Acronym / sponsor ID
- 329 / E6 / 07
- Keywords
- Early breast cancer surgery, Psychosocial wellbeing, Ambulatory surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Helsinki University Central HospitalUniversity, hospital or other
- Study start
- Mar 2008
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 7 Jun 2012 (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.
The aim was to assess the patient compliance and medical and psychosocial effects of same day hospital discharge after breast conserving surgery and sentinel node biopsy only.
Detailed description
The patients with small breast tumours (<2 cm)and clinically node negative disease, were randomized to receive breast conserving surgery and sentinel node biopsy as ambulatory surgery or inpatient-surgery.Complication rate, patient satisfaction and psychosocial outcomes were compared. The psychosocial effects of the treatment mode on their spouses were recorded as well.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Day surgery group | Experimental | Other: Ambulatory surgeryPatients who underwent breast conserving surgery and sentinel node biopsy only and were randomized to ambulatory surgery group. |
| In-Patient group | Active comparator | Other: Ambulatory surgeryPatients who underwent breast conserving surgery and sentinel node biopsy only and were randomized to in-patient group. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Breast cancer < 2cm
- Clinically node negative
- ASA I-II
Key exclusion criteria (3 listed)
- Axillary clearance performed
- ASA III-IV
- No adult companion at home
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 |
|---|---|---|
| Ambulatory surgerySentinel node mapping was done on the previous day and the patients were operated on first in the morning. | Other | Day surgery group, In-Patient group |
Primary outcome
Psychosocial wellfare
Time frame: First postoperative day
Difference between the groups in questionnaire measuring anxiety and psychosocial wellfare
1 secondary outcome
Number of complications and return to hospital rate
Time frame: one week
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 7 Jun 2012.
- Derived from this study: PubMed 25922474Ojala K, Vironen JH, Mattila K, Eklund AM, Leidenius MH, Meretoja TJ. Feasibility of Day Surgery in Patients With Breast Conservation and Sentinel Node Biopsy: A Randomized Controlled Trial. Scand J Surg. 2016 Mar;105(1):29-34. doi: 10.1177/1457496915583201. Epub 2015 Apr 28.
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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.
Jaana H Vironen, MD, PhD principal investigator
Helsinki University Central Hospital, Jorvi Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ambulatory surgery in people with Early Breast Cancer and Psychosocial Wellbeing, run by Helsinki University Central Hospital at 1 site in Finland.
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 3 inclusion and 3 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 7 Jun 2012. 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 Finland. 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?
Psychosocial wellfare (time frame: First postoperative day). 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 NCT01613352, 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 7 Jun 2012.