Feasibility of Ambulatory Surgery for Early Breast Cancer

NCT01613352 — Not applicable, Completed, 100 participants, Helsinki University Central Hospital

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

Registry	NCT01613352
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: none, health services research
Enrollment	100 (Actual)
Sponsor	Helsinki University Central Hospital (Other)
Conditions	Early Breast Cancer, Psychosocial Wellbeing, Ambulatory Surgery
Interventions	Ambulatory surgery (Other)
Dates	start 2008-03-01, primary completion 2011-04-01, completion 2011-04-01, first posted 2012-06-07, last updated 2012-06-07
Locations	1 site in Finland

-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.

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
Day surgery group	Experimental	Other: Ambulatory surgery	Patients who underwent breast conserving surgery and sentinel node biopsy only and were randomized to ambulatory surgery group.
In-Patient group	Active comparator	Other: Ambulatory surgery	Patients who underwent breast conserving surgery and sentinel node biopsy only and were randomized to in-patient group.

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

+Outcome measures

Primary outcomes

Psychosocial wellfare [First postoperative day]: Difference between the groups in questionnaire measuring anxiety and psychosocial wellfare

Secondary outcomes

Number of complications and return to hospital rate [one week]: The difference in the number of complications or return to the hospital rate between the groups

+Eligibility

Sex: Female, ages: 18 Years to 90 Years

Inclusion Criteria:

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

Exclusion Criteria:

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

+Locations (1)

Facility	City	Country	Status
Helsinki University Central Hospital, Jorvi Hospital	Espoo, HUS	Finland

+Publications

Results publication: 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 25922474

+Investigators

Jaana H Vironen, MD, PhD, Principal investigator, Helsinki University Central Hospital, Jorvi Hospital

My Notes

Public

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