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Completed

NCT Number: NCT01613352

Feasibility of Ambulatory Surgery for Early Breast Cancer

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.

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Key information

Conditions

Early Breast Cancer Ambulatory Surgery Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Psychosocial Wellbeing Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–90 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Helsinki University Central Hospital, Jorvi Hospital

Espoo, HUS, 00029, Finland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Ambulatory surgery

Other

Sentinel node mapping was done on the previous day and the patients were operated on first in the morning.

Primary outcomes

  1. Psychosocial wellfare

    Time frame: First postoperative day

    Difference between the groups in questionnaire measuring anxiety and psychosocial wellfare

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Helsinki University Central Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Jun 7, 2012
Registry last updated
Jun 7, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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