Feasibility of Ambulatory Surgery for Early Breast Cancer

Early Breast Cancer Clinical Trial

Official title:

Same Day Discharge After Surgery for Early Breast Cancer - a Feasible Option

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01613352
• Other study ID #: 329 / E6 / 07
• Status: Completed
• Phase: N/A
• First received: June 5, 2012
• Last updated: June 5, 2012
• Start date: March 2008
• Est. completion date: April 2011

Study information

• Verified date: June 2012
• Source: Helsinki University Central Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland:Valvira
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: April 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 90 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Ambulatory Surgery
• Breast Neoplasms
• Early Breast Cancer
• Psychosocial Wellbeing

Intervention

Other:
• Ambulatory surgery
Sentinel node mapping was done on the previous day and the patients were operated on first in the morning.

Locations

Country	Name	City	State
Finland	Helsinki University Central Hospital, Jorvi Hospital	Espoo	HUS

Sponsors (1)

Lead Sponsor	Collaborator
Helsinki University Central Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Psychosocial wellfare	Difference between the groups in questionnaire measuring anxiety and psychosocial wellfare	First postoperative day	No
Secondary	Number of complications and return to hospital rate	The difference in the number of complications or return to the hospital rate between the groups	one week	Yes