Back to resultsFeasibility of Ambulatory Surgery for Early Breast Cancer
Primary Purpose
Early Breast Cancer, Psychosocial Wellbeing, Ambulatory Surgery
Status
Completed
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Ambulatory surgery
Sponsored by
About this trial
This is an interventional health services research trial for Early Breast Cancer focused on measuring Early breast cancer surgery, Psychosocial wellbeing, Ambulatory surgery
Eligibility Criteria
Inclusion Criteria:
- Breast cancer < 2cm
- Clinically node negative
- ASA I-II
Exclusion Criteria:
- Axillary clearance performed
- ASA III-IV
- No adult companion at home
Sites / Locations
- Helsinki University Central Hospital, Jorvi Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Day surgery group
In-Patient group
Arm Description
Patients who underwent breast conserving surgery and sentinel node biopsy only and were randomized to ambulatory surgery group.
Patients who underwent breast conserving surgery and sentinel node biopsy only and were randomized to in-patient group.
Outcomes
Primary Outcome Measures
Psychosocial wellfare
Difference between the groups in questionnaire measuring anxiety and psychosocial wellfare
Secondary Outcome Measures
Number of complications and return to hospital rate
The difference in the number of complications or return to the hospital rate between the groups
Full Information
NCT ID
NCT01613352
First Posted
June 5, 2012
Last Updated
June 5, 2012
Sponsor
Helsinki University Central Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01613352
Brief Title
Feasibility of Ambulatory Surgery for Early Breast Cancer
Official Title
Same Day Discharge After Surgery for Early Breast Cancer - a Feasible Option
Study Type
Interventional
2. Study Status
Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
April 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Helsinki University Central Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Early Breast Cancer, Psychosocial Wellbeing, Ambulatory Surgery
Keywords
Early breast cancer surgery, Psychosocial wellbeing, Ambulatory surgery
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Day surgery group
Arm Type
Experimental
Arm Description
Patients who underwent breast conserving surgery and sentinel node biopsy only and were randomized to ambulatory surgery group.
Arm Title
In-Patient group
Arm Type
Active Comparator
Arm Description
Patients who underwent breast conserving surgery and sentinel node biopsy only and were randomized to in-patient group.
Intervention Type
Other
Intervention Name(s)
Ambulatory surgery
Intervention Description
Sentinel node mapping was done on the previous day and the patients were operated on first in the morning.
Primary Outcome Measure Information:
Title
Psychosocial wellfare
Description
Difference between the groups in questionnaire measuring anxiety and psychosocial wellfare
Time Frame
First postoperative day
Secondary Outcome Measure Information:
Title
Number of complications and return to hospital rate
Description
The difference in the number of complications or return to the hospital rate between the groups
Time Frame
one week
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Breast cancer < 2cm
Clinically node negative
ASA I-II
Exclusion Criteria:
Axillary clearance performed
ASA III-IV
No adult companion at home
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jaana H Vironen, MD, PhD
Organizational Affiliation
Helsinki University Central Hospital, Jorvi Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Helsinki University Central Hospital, Jorvi Hospital
City
Espoo
State/Province
HUS
ZIP/Postal Code
00029
Country
Finland
12. IPD Sharing Statement
Citations:
PubMed Identifier
25922474
Citation
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.
Results Reference
derived
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Feasibility of Ambulatory Surgery for Early Breast Cancer
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