Study Results
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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UNKNOWN
PHASE3
20 participants
INTERVENTIONAL
2012-06-30
2018-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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LigaSure Precise instrument
ALND with use of LigaSure Precise instrument, closure of dead space, omission of a postoperative drain.
LigaSure Precise instrument
LigaSure Precise instrument is used during Axillary Lymph Node Dissection Technique: Dead space closure Technique: Omission of postoperative drain
Interventions
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LigaSure Precise instrument
LigaSure Precise instrument is used during Axillary Lymph Node Dissection Technique: Dead space closure Technique: Omission of postoperative drain
Eligibility Criteria
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Inclusion Criteria
* 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
* Preoperative preexisting seroma.
18 Years
FEMALE
No
Sponsors
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The Netherlands Cancer Institute
OTHER
Responsible Party
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Principal Investigators
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Emiel Rutgers, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Netherlands Cancer Institute - Antoni van Leeuwenhoek
Locations
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Netherlands Cancer Institute - Antoni van Leeuwenhoek
Amsterdam, , Netherlands
Countries
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Central Contacts
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Facility Contacts
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References
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van Bemmel AJ, van de Velde CJ, Schmitz RF, Liefers GJ. Prevention of seroma formation after axillary dissection in breast cancer: a systematic review. Eur J Surg Oncol. 2011 Oct;37(10):829-35. doi: 10.1016/j.ejso.2011.04.012. Epub 2011 Aug 17.
Baas-Vrancken Peeters MJ, Kluit AB, Merkus JW, Breslau PJ. Short versus long-term postoperative drainage of the axilla after axillary lymph node dissection. A prospective randomized study. Breast Cancer Res Treat. 2005 Oct;93(3):271-5. doi: 10.1007/s10549-005-5348-7.
Classe JM, Berchery D, Campion L, Pioud R, Dravet F, Robard S. Randomized clinical trial comparing axillary padding with closed suction drainage for the axillary wound after lymphadenectomy for breast cancer. Br J Surg. 2006 Jul;93(7):820-4. doi: 10.1002/bjs.5433.
Ostapoff KT, Euhus D, Xie XJ, Rao M, Moldrem A, Rao R. Axillary lymph node dissection for breast cancer utilizing Harmonic Focus(R). World J Surg Oncol. 2011 Aug 15;9:90. doi: 10.1186/1477-7819-9-90.
Gong Y, Xu J, Shao J, Cheng H, Wu X, Zhao D, Xiong B. Prevention of seroma formation after mastectomy and axillary dissection by lymph vessel ligation and dead space closure: a randomized trial. Am J Surg. 2010 Sep;200(3):352-6. doi: 10.1016/j.amjsurg.2009.10.013. Epub 2010 Apr 20.
Other Identifiers
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N12PRE
Identifier Type: -
Identifier Source: org_study_id