Feasibility of Ambulatory Surgery for Early Breast Cancer
- Conditions
- Early Breast CancerPsychosocial WellbeingAmbulatory Surgery
- Interventions
- Other: Ambulatory surgery
- Registration Number
- NCT01613352
- Lead Sponsor
- Helsinki University Central Hospital
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 100
- Breast cancer < 2cm
- Clinically node negative
- ASA I-II
- Axillary clearance performed
- ASA III-IV
- No adult companion at home
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Day surgery group Ambulatory surgery Patients who underwent breast conserving surgery and sentinel node biopsy only and were randomized to ambulatory surgery group. In-Patient group Ambulatory surgery Patients who underwent breast conserving surgery and sentinel node biopsy only and were randomized to in-patient group.
- Primary Outcome Measures
Name Time Method Psychosocial wellfare First postoperative day Difference between the groups in questionnaire measuring anxiety and psychosocial wellfare
- Secondary Outcome Measures
Name Time Method Number of complications and return to hospital rate one week The difference in the number of complications or return to the hospital rate between the groups
Trial Locations
- Locations (1)
Helsinki University Central Hospital, Jorvi Hospital
🇫🇮Espoo, HUS, Finland