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Prospective Pilot Study ANDPrecise (ANDPrecise)

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ClinicalTrials.gov Identifier: NCT02292407
Recruitment Status : Unknown
Verified October 2014 by The Netherlands Cancer Institute.
Recruitment status was:  Recruiting
First Posted : November 17, 2014
Last Update Posted : November 17, 2014
Sponsor:
Information provided by (Responsible Party):
The Netherlands Cancer Institute

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Breast Cancer Device: LigaSure Precise instrument Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: AND Precise! : Axillary Lymph Node Dissection and No Drain With the PRECISE Instrument
Study Start Date : June 2012
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Number of seroma evacuations per patient [ Time Frame: within 3 months after surgery ]

Secondary Outcome Measures :
  1. Number of wound infections per patient [ Time Frame: within 3 months after surgery ]
  2. Number of hematomas per patient [ Time Frame: within 3 months after surgery ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02292407


Contacts
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Contact: Emiel Rutgers, MD, PhD +3120512 ext 2551 e.rutgers@nki.nl

Locations
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Netherlands
Netherlands Cancer Institute - Antoni van Leeuwenhoek Recruiting
Amsterdam, Netherlands, 1066CX
Contact: Emiel Rutgers, MD, PHD    +3120512 ext 2551    e.rutgers@nki.nl   
Sponsors and Collaborators
The Netherlands Cancer Institute
Investigators
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Principal Investigator: Emiel Rutgers, MD, PhD Netherlands Cancer Institute - Antoni van Leeuwenhoek
Publications:
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Responsible Party: The Netherlands Cancer Institute
ClinicalTrials.gov Identifier: NCT02292407    
Other Study ID Numbers: N12PRE
First Posted: November 17, 2014    Key Record Dates
Last Update Posted: November 17, 2014
Last Verified: October 2014