Impact of a Surgical Sealing Patch on Lymphatic Drainage After Axillary Dissection for Breast Cancer: The SAKK 23/13 Multicenter Randomized Phase III Trial.

Details

Serval ID
serval:BIB_04D24B9F2B6C
Type
Article: article from journal or magazin.
Collection
Publications
Title
Impact of a Surgical Sealing Patch on Lymphatic Drainage After Axillary Dissection for Breast Cancer: The SAKK 23/13 Multicenter Randomized Phase III Trial.
Journal
Annals of surgical oncology
Author(s)
Weber W.P., Tausch C., Hayoz S., Fehr M.K., Ribi K., Hawle H., Lupatsch J.E., Matter-Walstra K., Chiesa F., Dedes K.J., Berclaz G., Lelièvre L., Hess T., Güth U., Pioch V., Sarlos D., Leo C., Canonica C., Gabriel N., Zeindler J., Cassoly E., Andrieu C., Soysal S.D., Ruhstaller T., Fehr P.M., Knauer M.
Working group(s)
Swiss Group for Clinical Cancer Research (SAKK)
ISSN
1534-4681 (Electronic)
ISSN-L
1068-9265
Publication state
Published
Issued date
09/2018
Peer-reviewed
Oui
Volume
25
Number
9
Pages
2632-2640
Language
english
Notes
Publication types: Clinical Trial, Phase III ; Journal Article ; Multicenter Study ; Randomized Controlled Trial
Publication Status: ppublish
Abstract
Several studies and a meta-analysis showed that fibrin sealant patches reduced lymphatic drainage after various lymphadenectomy procedures. Our goal was to investigate the impact of these patches on drainage after axillary dissection for breast cancer.
In a phase III superiority trial, we randomized patients undergoing breast-conserving surgery at 14 Swiss sites to receive versus not receive three large TachoSil <sup>®</sup> patches in the dissected axilla. Axillary drains were inserted in all patients. Patients and investigators assessing outcomes were blinded to group assignment. The primary endpoint was total volume of drainage.
Between March 2015 and December 2016, 142 patients were randomized (72 with TachoSil <sup>®</sup> and 70 without). Mean total volume of drainage in the control group was 703 ml [95% confidence interval (CI) 512-895 ml]. Application of TachoSil <sup>®</sup> did not significantly reduce the total volume of axillary drainage [mean difference (MD) -110 ml, 95% CI -316 to 94, p = 0.30]. A total of eight secondary endpoints related to drainage, morbidity, and quality of life were not improved by use of TachoSil <sup>®</sup> . The mean total cost per patient did not differ significantly between the groups [34,253 Swiss Francs (95% CI 32,625-35,880) with TachoSil <sup>®</sup> and 33,365 Swiss Francs (95% CI 31,771-34,961) without, p = 0.584]. In the TachoSil <sup>®</sup> group, length of stay was longer (MD 1 day, 95% CI 0.3-1.7, p = 0.009), and improvement of pain was faster, although the latter difference was not significant [2 days (95% CI 1-4) vs. 5.5 days (95% CI 2-11); p = 0.2].
TachoSil <sup>®</sup> reduced drainage after axillary dissection for breast cancer neither significantly nor relevantly.
Keywords
Aged, Axilla, Breast Neoplasms/pathology, Breast Neoplasms/surgery, Drainage, Drug Combinations, Female, Fibrinogen/economics, Fibrinogen/therapeutic use, Health Care Costs, Humans, Length of Stay, Lymph Node Excision/adverse effects, Lymph Node Excision/economics, Mastectomy, Segmental, Middle Aged, Pain, Postoperative/etiology, Thrombin/economics, Thrombin/therapeutic use, Wound Closure Techniques/economics, Wound Closure Techniques/instrumentation
Pubmed
Web of science
Create date
28/06/2018 17:43
Last modification date
05/11/2019 7:26
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