Prospective Pilot Study ANDPrecise (ANDPrecise)

November 12, 2014 updated by: The Netherlands Cancer Institute

AND Precise! : Axillary Lymph Node Dissection and No Drain With the PRECISE Instrument

This study aims at providing first evidence that axillary clearance by using an operation technique including the precise LigaSure instrument and closure of dead space of the axilla will result in an operation were a drain is not necessary and the need for seroma evacuation after surgery is very limited.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Axillary clearance in breast cancer is usually performed by using a drain to prevent seroma formation and to support obliteration of the dead space in the axillary carry out. The hypothesis made in this protocol is that axillary clearance by using an operation technique including the use of the precise LigaSure instrument and closure of dead space can be done without using a postoperative drain.

The AND PRECISE PROTOCOL aims at providing first evidence that axillary clearance by using an operation technique including the precise LigaSure instrument and closure of dead space of the axilla will result in an operation were a drain is not necessary and the need for seroma evacuation after surgery is very limited Patients undergoing axillary clearance necessary for achieving reasonable control in invasive breast cancer and participating in the AND PRECISE protocol will undergo the operation by using a technique including the use of the precise LigaSure instrument and closure of dead space. Postoperatively, the numbers of seroma punctions and the amount of seroma will be recorded prospectively. Patients will be asked to record on a daily basis their experience of pain by a visual analog scale of pain.

The main study parameter is the percent of cases which successfully did not need seroma punctions after the intervention.

Potential disadvantages for the patient are risk for more seroma formation and discomfort. Patients will be asked to record on a daily basis their experience of pain by a visual analog scale of pain.

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Amsterdam, Netherlands, 1066CX
        • Recruiting
        • Netherlands Cancer Institute - Antoni van Leeuwenhoek
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Indications for axillary clearance can be a tumor positive sentinel node or tumor positive lymph nodes proven by ultrasound or fine needle aspiration cytology.
  • For this pilot, only patients undergoing breast conserving surgery are eligible.
  • Axillary clearance can be performed after previous sentinel node procedure, at the same operation, and after neo-adjuvant chemo therapy, and as secondary procedure in case of axillary relapse after previous treatment for breast cancer.

Exclusion Criteria:

  • Patients undergoing a modified radical mastectomy including an axillary clearance.
  • Preoperative preexisting seroma.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: LigaSure Precise instrument
ALND with use of LigaSure Precise instrument, closure of dead space, omission of a postoperative drain.
Device: LigaSure Precise instrument
LigaSure Precise instrument is used during Axillary Lymph Node Dissection Technique: Dead space closure Technique: Omission of postoperative drain

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of seroma evacuations per patient
Time Frame: within 3 months after surgery
within 3 months after surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of wound infections per patient
Time Frame: within 3 months after surgery
within 3 months after surgery
Number of hematomas per patient
Time Frame: within 3 months after surgery
within 3 months after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Netherlands Cancer Institute

Investigators

  • Principal Investigator: Emiel Rutgers, MD, PhD, Netherlands Cancer Institute - Antoni van Leeuwenhoek

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (ANTICIPATED)

June 1, 2017

Study Completion (ANTICIPATED)

June 1, 2018

Study Registration Dates

First Submitted

October 27, 2014

First Submitted That Met QC Criteria

November 12, 2014

First Posted (ESTIMATE)

November 17, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

November 17, 2014

Last Update Submitted That Met QC Criteria

November 12, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Other Study ID Numbers

  • N12PRE

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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