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Feasibility of Ambulatory Surgery for Early Breast Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jaana Vironen, Helsinki University Central Hospital
ClinicalTrials.gov Identifier:
NCT01613352
First received: June 5, 2012
Last updated: NA
Last verified: June 2012
History: No changes posted
  Purpose

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.


Condition Intervention
Early Breast Cancer
Psychosocial Wellbeing
Ambulatory Surgery
 Other: Ambulatory surgery

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Same Day Discharge After Surgery for Early Breast Cancer - a Feasible Option

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Helsinki University Central Hospital:

Primary Outcome Measures:
  • Psychosocial wellfare [ Time Frame: First postoperative day ] [ Designated as safety issue: No ]
    Difference between the groups in questionnaire measuring anxiety and psychosocial wellfare


Secondary Outcome Measures:
  • Number of complications and return to hospital rate [ Time Frame: one week ] [ Designated as safety issue: Yes ]
    The difference in the number of complications or return to the hospital rate between the groups


Enrollment: 100
Study Start Date: March 2008
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Axillary clearance performed
  • ASA III-IV
  • No adult companion at home
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01613352

Locations
Finland
Helsinki University Central Hospital, Jorvi Hospital
Espoo, HUS, Finland, 00029
Sponsors and Collaborators
Helsinki University Central Hospital
Investigators
Principal Investigator: Jaana H Vironen, MD, PhD Helsinki University Central Hospital, Jorvi Hospital
  More Information

No publications provided

Responsible Party: Jaana Vironen, Associate chief surgeon, Helsinki University Central Hospital
ClinicalTrials.gov Identifier: NCT01613352     History of Changes
Other Study ID Numbers: 329 / E6 / 07
Study First Received: June 5, 2012
Last Updated: June 5, 2012
Health Authority: Finland:Valvira

Keywords provided by Helsinki University Central Hospital:
Early breast cancer surgery
Psychosocial wellbeing
Ambulatory surgery

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on May 23, 2013