GALA: Use of Glubran 2 ® in Axillary Lymphadenectomy Without Drain
Study Details
Study Description
Brief Summary
Axillary lymphadenectomy in breast cancer continues to be a common practice in certain patients. The use of sealants and drains continues to be a source of disagreement among the scientific community. That is why the study was designed to show whether the sealant reduces seroma after axillary lymphadenectomy without drainage.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
A study has been designed to assess whether the sealant reduces the rate of symptomatic seroma measured by the number of evacuating punctures. Likewise, the decrease in volume due to the seroma between the two groups and the quality of life of the patients is assessed, given that none of them has a drain
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: lymphadenectomy without drainage and with Glubran Application of Glubran 2 in axillary dissection with the objective of seroma reduction. No drain |
Other: Glubran 2
Application of Glubran 2 sealant (liquid) in axillary hollow
|
| No Intervention: Lymphadenectomy without drainage No intervention required, only axillary dissection without drain |
Outcome Measures
Primary Outcome Measures
- Change in symptomatic seroma [Up tp 1 year]
Number of evacuating punctures
- Number of participants with treatment-related adverse events [Up to 1 year]
Type and number of adverse events
Secondary Outcome Measures
- Seroma volume [Day 7 and 14 after surgery]
Volume measured by ultrasound (cm3 )
- Milliliters of evacuated seroma in case of puncture [7, 14 and 30 day after surgery]
Assess if there are differences in the volume of seroma evacuated (milliliters) between groups
- Demographic characteristics of patients related to seroma [Up to 1 year]
Assess the existence of risk factors (age, sex, obesity,neoadjuvant treatment) related to symptomatic seroma
- Number of patients with temporary or permanence of disability after operation [Up to 1 year]
Clavien-Dindo classification of morbidity
- Individual's perception of the position in life of the participants [Day 7 and 14 after surgery]
Assess the quality of life after the intervention measured by the EuroQol five dimensions (EQ-5D-5L questionnaire). Descriptive system for health-related quality of life states in adults, consisting of five dimensions. No quality 0 points. Perfect quality 100 points
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Over 18 years old
-
Conservative surgery for breast cancer with associated axillary lymphadenectomy
Exclusion Criteria:
-
Mastectomy
-
History of axillary surgery or ipsilateral axillary radiotherapy
-
ASA 4 patients. (ASA 3 patients selected)
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Lack of adequate cognitive capacity and/or signed informed consent
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Pregnancy
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Omphis Foundation
- Consorci Sanitari del Maresme
Investigators
- Principal Investigator: Sandra Lopez Gordo, Doctor, Health Consortium Maresme
Study Documents (Full-Text)
None provided.More Information
Publications
- Chang YT, Shih SL, Loh EW, Tam KW. Effects of Fibrin Sealant on Seroma Reduction for Patients with Breast Cancer Undergoing Axillary Dissection: Meta-Analysis of Randomized Controlled Trials. Ann Surg Oncol. 2020 Dec;27(13):5286-5295. doi: 10.1245/s10434-020-08747-5. Epub 2020 Jun 20.
- Giuliano AE, Ballman KV, McCall L, Beitsch PD, Brennan MB, Kelemen PR, Ollila DW, Hansen NM, Whitworth PW, Blumencranz PW, Leitch AM, Saha S, Hunt KK, Morrow M. Effect of Axillary Dissection vs No Axillary Dissection on 10-Year Overall Survival Among Women With Invasive Breast Cancer and Sentinel Node Metastasis: The ACOSOG Z0011 (Alliance) Randomized Clinical Trial. JAMA. 2017 Sep 12;318(10):918-926. doi: 10.1001/jama.2017.11470.
- Gunn J, Gibson T, Li Z, Diehl N, Bagaria S, McLaughlin S. Symptomatic Axillary Seroma after Sentinel Lymph Node Biopsy: Incidence and Treatment. Ann Surg Oncol. 2016 Oct;23(10):3347-53. doi: 10.1245/s10434-016-5398-6. Epub 2016 Jul 8.
- Jain PK, Sowdi R, Anderson AD, MacFie J. Randomized clinical trial investigating the use of drains and fibrin sealant following surgery for breast cancer. Br J Surg. 2004 Jan;91(1):54-60.
- Srivastava V, Basu S, Shukla VK. Seroma formation after breast cancer surgery: what we have learned in the last two decades. J Breast Cancer. 2012 Dec;15(4):373-80. doi: 10.4048/jbc.2012.15.4.373. Epub 2012 Dec 31.
- Thomson DR, Sadideen H, Furniss D. Wound drainage after axillary dissection for carcinoma of the breast. Cochrane Database Syst Rev. 2013 Oct 20;(10):CD006823. doi: 10.1002/14651858.CD006823.pub2. Review.
- Thorpe KE, Zwarenstein M, Oxman AD, Treweek S, Furberg CD, Altman DG, Tunis S, Bergel E, Harvey I, Magid DJ, Chalkidou K. A pragmatic-explanatory continuum indicator summary (PRECIS): a tool to help trial designers. J Clin Epidemiol. 2009 May;62(5):464-75. doi: 10.1016/j.jclinepi.2008.12.011.
- 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. Review.
- Vasileiadou K, Kosmidis C, Anthimidis G, Miliaras S, Kostopoulos I, Fahantidis E. Cyanoacrylate Adhesive Reduces Seroma Production After Modified Radical Mastectomy or Quadrantectomy With Lymph Node Dissection-A Prospective Randomized Clinical Trial. Clin Breast Cancer. 2017 Dec;17(8):595-600. doi: 10.1016/j.clbc.2017.04.004. Epub 2017 Apr 13.
- Health consortium maresme