Feasibility of Ambulatory Surgery for Early Breast Cancer

Not Applicable

Completed

• Conditions: Early Breast Cancer; Psychosocial Wellbeing; 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.

Study Timeline

• Study Start: 2008-03
• Primary Completion: 2011-04
• Study Completion: 2011-04
• Status Verified: 2012-06
• Study First Submitted: 2012-06-05
• Study First Submitted QC: 2012-06-05
• Last Update Submitted: 2012-06-05
• Study First Posted: 2012-06-07
• Last Update Posted: 2012-06-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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