NCT01613352

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2008

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2008

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

June 5, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 7, 2012

Completed
Last Updated

June 7, 2012

Status Verified

June 1, 2012

Enrollment Period

3.1 years

First QC Date

June 5, 2012

Last Update Submit

June 5, 2012

Conditions

Early Breast CancerPsychosocial WellbeingAmbulatory Surgery

Keywords

Early breast cancer surgeryPsychosocial wellbeingAmbulatory surgery

Outcome Measures

Primary Outcomes (1)

  • Psychosocial wellfare

    Difference between the groups in questionnaire measuring anxiety and psychosocial wellfare

    First postoperative day

Secondary Outcomes (1)

  • Number of complications and return to hospital rate

    one week

Study Arms (2)

Day surgery group

EXPERIMENTAL

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

Other: Ambulatory surgery

In-Patient group

ACTIVE COMPARATOR

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

Other: Ambulatory surgery

Interventions

Ambulatory surgeryOTHER

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

Day surgery groupIn-Patient group

Eligibility Criteria

Age18 Years - 90 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Helsinki University Central Hospital, Jorvi Hospital

Espoo, HUS, 00029, Finland

Location

Related Publications (1)

  • Ojala K, Vironen JH, Mattila K, Eklund AM, Leidenius MH, Meretoja TJ. Feasibility of Day Surgery in Patients With Breast Conservation and Sentinel Node Biopsy: A Randomized Controlled Trial. Scand J Surg. 2016 Mar;105(1):29-34. doi: 10.1177/1457496915583201. Epub 2015 Apr 28.

    PMID: 25922474DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Ambulatory Surgical Procedures

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Officials

  • Jaana H Vironen, MD, PhD

    Helsinki University Central Hospital, Jorvi Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate chief surgeon

Study Record Dates

First Submitted

June 5, 2012

First Posted

June 7, 2012

Study Start

March 1, 2008

Primary Completion

April 1, 2011

Study Completion

April 1, 2011

Last Updated

June 7, 2012

Record last verified: 2012-06

Locations

FI(1)