Feasibility of Ambulatory Surgery for Early Breast Cancer

June 5, 2012 updated by: Jaana Vironen, Helsinki University Central Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
    • HUS
      • Espoo, HUS, Finland, 00029
        • Helsinki University Central Hospital, Jorvi Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Day surgery group
Patients who underwent breast conserving surgery and sentinel node biopsy only and were randomized to ambulatory surgery group.
Other: Ambulatory surgery
Sentinel node mapping was done on the previous day and the patients were operated on first in the morning.
Active Comparator: In-Patient group
Patients who underwent breast conserving surgery and sentinel node biopsy only and were randomized to in-patient group.
Other: Ambulatory surgery
Sentinel node mapping was done on the previous day and the patients were operated on first in the morning.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Psychosocial wellfare
Time Frame: First postoperative day
Difference between the groups in questionnaire measuring anxiety and psychosocial wellfare
First postoperative day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of complications and return to hospital rate
Time Frame: one week
The difference in the number of complications or return to the hospital rate between the groups
one week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Helsinki University Central Hospital

Investigators

  • Principal Investigator: Jaana H Vironen, MD, PhD, Helsinki University Central Hospital, Jorvi Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2008

Primary Completion (Actual)

April 1, 2011

Study Completion (Actual)

April 1, 2011

Study Registration Dates

First Submitted

June 5, 2012

First Submitted That Met QC Criteria

June 5, 2012

First Posted (Estimate)

June 7, 2012

Study Record Updates

Last Update Posted (Estimate)

June 7, 2012

Last Update Submitted That Met QC Criteria

June 5, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 329 / E6 / 07

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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