Feasibility of Ambulatory Surgery for Early Breast Cancer
June 5, 2012 updated by: Jaana Vironen, Helsinki University Central Hospital
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.
Study Overview
Status
Completed
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
HUS
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Espoo, HUS, Finland, 00029
- Helsinki University Central Hospital, Jorvi Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Breast cancer < 2cm
- Clinically node negative
- ASA I-II
Exclusion Criteria:
- Axillary clearance performed
- ASA III-IV
- No adult companion at home
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Day surgery group
Patients who underwent breast conserving surgery and sentinel node biopsy only and were randomized to ambulatory surgery group.
|
Sentinel node mapping was done on the previous day and the patients were operated on first in the morning.
|
|
Active Comparator: In-Patient group
Patients who underwent breast conserving surgery and sentinel node biopsy only and were randomized to in-patient group.
|
Sentinel node mapping was done on the previous day and the patients were operated on first in the morning.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Psychosocial wellfare
Time Frame: First postoperative day
|
Difference between the groups in questionnaire measuring anxiety and psychosocial wellfare
|
First postoperative day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of complications and return to hospital rate
Time Frame: one week
|
The difference in the number of complications or return to the hospital rate between the groups
|
one week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Jaana H Vironen, MD, PhD, Helsinki University Central Hospital, Jorvi Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2008
Primary Completion (Actual)
April 1, 2011
Study Completion (Actual)
April 1, 2011
Study Registration Dates
First Submitted
June 5, 2012
First Submitted That Met QC Criteria
June 5, 2012
First Posted (Estimate)
June 7, 2012
Study Record Updates
Last Update Posted (Estimate)
June 7, 2012
Last Update Submitted That Met QC Criteria
June 5, 2012
Last Verified
June 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 329 / E6 / 07
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.