Feasibility of Ambulatory Surgery for Early Breast Cancer

Helsinki University Central Hospital (HUCH)

Status: Completed

Conditions: Psychosocial Wellbeing; Ambulatory Surgery; Early Breast Cancer

Treatments: Other: Ambulatory surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT01613352

329 / E6 / 07

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: Female

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Breast cancer < 2cm
• Clinically node negative
• ASA I-II

Exclusion criteria

• Axillary clearance performed
• ASA III-IV
• No adult companion at home

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Day surgery group

Experimental group

Description:

Patients who underwent breast conserving surgery and sentinel node biopsy only and were randomized to ambulatory surgery group.

Treatment:

Other: Ambulatory surgery

In-Patient group

Active Comparator group

Description:

Patients who underwent breast conserving surgery and sentinel node biopsy only and were randomized to in-patient group.

Treatment:

Other: Ambulatory surgery