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
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Device: LigaSure Precise instrument||Phase 3|
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 (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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
- Number of seroma evacuations per patient [ Time Frame: within 3 months after surgery ]
- Number of wound infections per patient [ Time Frame: within 3 months after surgery ]
- Number of hematomas per patient [ Time Frame: within 3 months after surgery ]
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
|Contact: Emiel Rutgers, MD, PhD||+3120512 ext firstname.lastname@example.org|
|Netherlands Cancer Institute - Antoni van Leeuwenhoek||Recruiting|
|Amsterdam, Netherlands, 1066CX|
|Contact: Emiel Rutgers, MD, PHD +3120512 ext 2551 email@example.com|
|Principal Investigator:||Emiel Rutgers, MD, PhD||Netherlands Cancer Institute - Antoni van Leeuwenhoek|