Feasibility of Ambulatory Surgery for Early Breast Cancer

NCT ID: NCT01613352

Last Updated: 2012-06-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Study Completion Date

2011-04-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Early Breast Cancer Psychosocial Wellbeing Ambulatory Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Day surgery group

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

Group Type EXPERIMENTAL

Ambulatory surgery

Intervention Type OTHER

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

In-Patient group

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

Group Type ACTIVE_COMPARATOR

Ambulatory surgery

Intervention Type OTHER

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

Interventions

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Ambulatory surgery

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Helsinki University Central Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jaana Vironen

Associate chief surgeon

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jaana H Vironen, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Helsinki University Central Hospital, Jorvi Hospital

Locations

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Helsinki University Central Hospital, Jorvi Hospital

Espoo, HUS, Finland

Site Status

Countries

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Finland

References

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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.

Reference Type DERIVED
PMID: 25922474 (View on PubMed)

Other Identifiers

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329 / E6 / 07

Identifier Type: -

Identifier Source: org_study_id

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