Impact of a Surgical Sealing Patch on Lymphatic Drainage After Axillary Dissection for Breast Cancer: The SAKK 23/13 Multicenter Randomized Phase III Trial
Background 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. Methods In a phase III superiority t...
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| Veröffentlicht in: | Annals of surgical oncology 2018-09, Vol.25 (9), p.2632-2640 |
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| creator | Weber, Walter Paul Tausch, Christoph Hayoz, Stefanie Fehr, Mathias Konrad Ribi, Karin Hawle, Hanne Lupatsch, Judith Eva Matter-Walstra, Klazien Chiesa, Federica Dedes, Konstantin Johannes Berclaz, Gilles Lelièvre, Loic Hess, Thomas Güth, Uwe Pioch, Verena Sarlos, Dimitri Leo, Cornelia Canonica, Claudia Gabriel, Natalie Zeindler, Jasmin Cassoly, Estelle Andrieu, Christiane Soysal, Savas Deniz Ruhstaller, Thomas Fehr, Peter Martin Knauer, Michael |
| description | Background
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.
Methods
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
®
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.
Results
Between March 2015 and December 2016, 142 patients were randomized (72 with TachoSil
®
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
®
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
®
. 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
®
and 33,365 Swiss Francs (95% CI 31,771–34,961) without,
p
= 0.584]. In the TachoSil
®
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].
Conclusions
TachoSil
®
reduced drainage after axillary dissection for breast cancer neither significantly nor relevantly. |
| doi_str_mv | 10.1245/s10434-018-6556-9 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_miscellaneous_2060867449</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>2052550334</sourcerecordid><originalsourceid>FETCH-LOGICAL-c372t-8ed0bca835ecd87b077b4e1ad41a651296e94873abcb336d5ad605163acedd6d3</originalsourceid><addsrcrecordid>eNp1kU1v1DAQhiNERUvhB3BBI3HhktaOP5JwW7ZQoi6iYpdzNLEnu67ysdiJRPkr_Fm82kIlJE62PI8fe-ZNklecXfBMqsvAmRQyZbxItVI6LZ8kZ1zFE6kL_jTumS7SMtPqNHkewh1jPBdMPUtOs7KUheTFWfKr6vdoJhhbQFjPfusMdrAm7NywhVuczA7GAVb3_X6HkzNw5dENuCVYtBN5WPxwXYf-Hq5cCGQmF-F29PDeE4YJljgY8u9gsyNYL25uIBOXXMDnuYsuGg6GrzjYsXc_ycLtDgNBVVWw8Q67F8lJi12glw_refLt44fN8lO6-nJdLRer1Ig8m9KCLGsMFkKRsUXesDxvJHG0kqNWPCs1xW5zgY1phNBWodVMcS3QkLXaivPk7dG79-P3mcJU9y4Yin0NNM6hzphmhc6lLCP65h_0bpz9EH8XKZUpxYSQkeJHyvgxBE9tvfeuj1OqOasPydXH5OqYXH1Irj6YXz-Y56Yn-_fGn6gikB2BEEvDlvzj0_-3_gZV2qLS</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2052550334</pqid></control><display><type>article</type><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</title><source>MEDLINE</source><source>SpringerLink Journals</source><creator>Weber, Walter Paul ; Tausch, Christoph ; Hayoz, Stefanie ; Fehr, Mathias Konrad ; Ribi, Karin ; Hawle, Hanne ; Lupatsch, Judith Eva ; Matter-Walstra, Klazien ; Chiesa, Federica ; Dedes, Konstantin Johannes ; Berclaz, Gilles ; Lelièvre, Loic ; Hess, Thomas ; Güth, Uwe ; Pioch, Verena ; Sarlos, Dimitri ; Leo, Cornelia ; Canonica, Claudia ; Gabriel, Natalie ; Zeindler, Jasmin ; Cassoly, Estelle ; Andrieu, Christiane ; Soysal, Savas Deniz ; Ruhstaller, Thomas ; Fehr, Peter Martin ; Knauer, Michael</creator><creatorcontrib>Weber, Walter Paul ; Tausch, Christoph ; Hayoz, Stefanie ; Fehr, Mathias Konrad ; Ribi, Karin ; Hawle, Hanne ; Lupatsch, Judith Eva ; Matter-Walstra, Klazien ; Chiesa, Federica ; Dedes, Konstantin Johannes ; Berclaz, Gilles ; Lelièvre, Loic ; Hess, Thomas ; Güth, Uwe ; Pioch, Verena ; Sarlos, Dimitri ; Leo, Cornelia ; Canonica, Claudia ; Gabriel, Natalie ; Zeindler, Jasmin ; Cassoly, Estelle ; Andrieu, Christiane ; Soysal, Savas Deniz ; Ruhstaller, Thomas ; Fehr, Peter Martin ; Knauer, Michael ; Swiss Group for Clinical Cancer Research (SAKK) ; for the Swiss Group for Clinical Cancer Research (SAKK)</creatorcontrib><description>Background
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.
Methods
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
®
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.
Results
Between March 2015 and December 2016, 142 patients were randomized (72 with TachoSil
®
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
®
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
®
. 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
®
and 33,365 Swiss Francs (95% CI 31,771–34,961) without,
p
= 0.584]. In the TachoSil
®
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].
Conclusions
TachoSil
®
reduced drainage after axillary dissection for breast cancer neither significantly nor relevantly.</description><identifier>ISSN: 1068-9265</identifier><identifier>EISSN: 1534-4681</identifier><identifier>DOI: 10.1245/s10434-018-6556-9</identifier><identifier>PMID: 29948418</identifier><language>eng</language><publisher>Cham: Springer International Publishing</publisher><subject>Aged ; Axilla ; Biopsy ; Breast cancer ; Breast Neoplasms - pathology ; Breast Neoplasms - surgery ; Breast Oncology ; Dissection ; Drainage ; Drug Combinations ; Female ; Fibrin ; Fibrinogen - economics ; Fibrinogen - therapeutic use ; Health Care Costs ; Humans ; Length of Stay ; Lymph Node Excision - adverse effects ; Lymph Node Excision - economics ; Lymphatic drainage ; Mastectomy ; Mastectomy, Segmental ; Medicine ; Medicine & Public Health ; Middle Aged ; Morbidity ; Oncology ; Pain ; Pain, Postoperative - etiology ; Quality of life ; Surgery ; Surgical Oncology ; Thrombin - economics ; Thrombin - therapeutic use ; Wound Closure Techniques - economics ; Wound Closure Techniques - instrumentation</subject><ispartof>Annals of surgical oncology, 2018-09, Vol.25 (9), p.2632-2640</ispartof><rights>Society of Surgical Oncology 2018</rights><rights>Annals of Surgical Oncology is a copyright of Springer, (2018). All Rights Reserved.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c372t-8ed0bca835ecd87b077b4e1ad41a651296e94873abcb336d5ad605163acedd6d3</citedby><cites>FETCH-LOGICAL-c372t-8ed0bca835ecd87b077b4e1ad41a651296e94873abcb336d5ad605163acedd6d3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://link.springer.com/content/pdf/10.1245/s10434-018-6556-9$$EPDF$$P50$$Gspringer$$H</linktopdf><linktohtml>$$Uhttps://link.springer.com/10.1245/s10434-018-6556-9$$EHTML$$P50$$Gspringer$$H</linktohtml><link.rule.ids>314,777,781,27905,27906,41469,42538,51300</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/29948418$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Weber, Walter Paul</creatorcontrib><creatorcontrib>Tausch, Christoph</creatorcontrib><creatorcontrib>Hayoz, Stefanie</creatorcontrib><creatorcontrib>Fehr, Mathias Konrad</creatorcontrib><creatorcontrib>Ribi, Karin</creatorcontrib><creatorcontrib>Hawle, Hanne</creatorcontrib><creatorcontrib>Lupatsch, Judith Eva</creatorcontrib><creatorcontrib>Matter-Walstra, Klazien</creatorcontrib><creatorcontrib>Chiesa, Federica</creatorcontrib><creatorcontrib>Dedes, Konstantin Johannes</creatorcontrib><creatorcontrib>Berclaz, Gilles</creatorcontrib><creatorcontrib>Lelièvre, Loic</creatorcontrib><creatorcontrib>Hess, Thomas</creatorcontrib><creatorcontrib>Güth, Uwe</creatorcontrib><creatorcontrib>Pioch, Verena</creatorcontrib><creatorcontrib>Sarlos, Dimitri</creatorcontrib><creatorcontrib>Leo, Cornelia</creatorcontrib><creatorcontrib>Canonica, Claudia</creatorcontrib><creatorcontrib>Gabriel, Natalie</creatorcontrib><creatorcontrib>Zeindler, Jasmin</creatorcontrib><creatorcontrib>Cassoly, Estelle</creatorcontrib><creatorcontrib>Andrieu, Christiane</creatorcontrib><creatorcontrib>Soysal, Savas Deniz</creatorcontrib><creatorcontrib>Ruhstaller, Thomas</creatorcontrib><creatorcontrib>Fehr, Peter Martin</creatorcontrib><creatorcontrib>Knauer, Michael</creatorcontrib><creatorcontrib>Swiss Group for Clinical Cancer Research (SAKK)</creatorcontrib><creatorcontrib>for the Swiss Group for Clinical Cancer Research (SAKK)</creatorcontrib><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</title><title>Annals of surgical oncology</title><addtitle>Ann Surg Oncol</addtitle><addtitle>Ann Surg Oncol</addtitle><description>Background
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.
Methods
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
®
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.
Results
Between March 2015 and December 2016, 142 patients were randomized (72 with TachoSil
®
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
®
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
®
. 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
®
and 33,365 Swiss Francs (95% CI 31,771–34,961) without,
p
= 0.584]. In the TachoSil
®
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].
Conclusions
TachoSil
®
reduced drainage after axillary dissection for breast cancer neither significantly nor relevantly.</description><subject>Aged</subject><subject>Axilla</subject><subject>Biopsy</subject><subject>Breast cancer</subject><subject>Breast Neoplasms - pathology</subject><subject>Breast Neoplasms - surgery</subject><subject>Breast Oncology</subject><subject>Dissection</subject><subject>Drainage</subject><subject>Drug Combinations</subject><subject>Female</subject><subject>Fibrin</subject><subject>Fibrinogen - economics</subject><subject>Fibrinogen - therapeutic use</subject><subject>Health Care Costs</subject><subject>Humans</subject><subject>Length of Stay</subject><subject>Lymph Node Excision - adverse effects</subject><subject>Lymph Node Excision - economics</subject><subject>Lymphatic drainage</subject><subject>Mastectomy</subject><subject>Mastectomy, Segmental</subject><subject>Medicine</subject><subject>Medicine & Public Health</subject><subject>Middle Aged</subject><subject>Morbidity</subject><subject>Oncology</subject><subject>Pain</subject><subject>Pain, Postoperative - etiology</subject><subject>Quality of life</subject><subject>Surgery</subject><subject>Surgical Oncology</subject><subject>Thrombin - economics</subject><subject>Thrombin - therapeutic use</subject><subject>Wound Closure Techniques - economics</subject><subject>Wound Closure Techniques - instrumentation</subject><issn>1068-9265</issn><issn>1534-4681</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2018</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><recordid>eNp1kU1v1DAQhiNERUvhB3BBI3HhktaOP5JwW7ZQoi6iYpdzNLEnu67ysdiJRPkr_Fm82kIlJE62PI8fe-ZNklecXfBMqsvAmRQyZbxItVI6LZ8kZ1zFE6kL_jTumS7SMtPqNHkewh1jPBdMPUtOs7KUheTFWfKr6vdoJhhbQFjPfusMdrAm7NywhVuczA7GAVb3_X6HkzNw5dENuCVYtBN5WPxwXYf-Hq5cCGQmF-F29PDeE4YJljgY8u9gsyNYL25uIBOXXMDnuYsuGg6GrzjYsXc_ycLtDgNBVVWw8Q67F8lJi12glw_refLt44fN8lO6-nJdLRer1Ig8m9KCLGsMFkKRsUXesDxvJHG0kqNWPCs1xW5zgY1phNBWodVMcS3QkLXaivPk7dG79-P3mcJU9y4Yin0NNM6hzphmhc6lLCP65h_0bpz9EH8XKZUpxYSQkeJHyvgxBE9tvfeuj1OqOasPydXH5OqYXH1Irj6YXz-Y56Yn-_fGn6gikB2BEEvDlvzj0_-3_gZV2qLS</recordid><startdate>20180901</startdate><enddate>20180901</enddate><creator>Weber, Walter Paul</creator><creator>Tausch, Christoph</creator><creator>Hayoz, Stefanie</creator><creator>Fehr, Mathias Konrad</creator><creator>Ribi, Karin</creator><creator>Hawle, Hanne</creator><creator>Lupatsch, Judith Eva</creator><creator>Matter-Walstra, Klazien</creator><creator>Chiesa, Federica</creator><creator>Dedes, Konstantin Johannes</creator><creator>Berclaz, Gilles</creator><creator>Lelièvre, Loic</creator><creator>Hess, Thomas</creator><creator>Güth, Uwe</creator><creator>Pioch, Verena</creator><creator>Sarlos, Dimitri</creator><creator>Leo, Cornelia</creator><creator>Canonica, Claudia</creator><creator>Gabriel, Natalie</creator><creator>Zeindler, Jasmin</creator><creator>Cassoly, Estelle</creator><creator>Andrieu, Christiane</creator><creator>Soysal, Savas Deniz</creator><creator>Ruhstaller, Thomas</creator><creator>Fehr, Peter Martin</creator><creator>Knauer, Michael</creator><general>Springer International Publishing</general><general>Springer Nature B.V</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>7TO</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>8AO</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>H94</scope><scope>K9.</scope><scope>M0S</scope><scope>M1P</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>7X8</scope></search><sort><creationdate>20180901</creationdate><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</title><author>Weber, Walter Paul ; Tausch, Christoph ; Hayoz, Stefanie ; Fehr, Mathias Konrad ; Ribi, Karin ; Hawle, Hanne ; Lupatsch, Judith Eva ; Matter-Walstra, Klazien ; Chiesa, Federica ; Dedes, Konstantin Johannes ; Berclaz, Gilles ; Lelièvre, Loic ; Hess, Thomas ; Güth, Uwe ; Pioch, Verena ; Sarlos, Dimitri ; Leo, Cornelia ; Canonica, Claudia ; Gabriel, Natalie ; Zeindler, Jasmin ; Cassoly, Estelle ; Andrieu, Christiane ; Soysal, Savas Deniz ; Ruhstaller, Thomas ; Fehr, Peter Martin ; Knauer, Michael</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c372t-8ed0bca835ecd87b077b4e1ad41a651296e94873abcb336d5ad605163acedd6d3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2018</creationdate><topic>Aged</topic><topic>Axilla</topic><topic>Biopsy</topic><topic>Breast cancer</topic><topic>Breast Neoplasms - pathology</topic><topic>Breast Neoplasms - surgery</topic><topic>Breast Oncology</topic><topic>Dissection</topic><topic>Drainage</topic><topic>Drug Combinations</topic><topic>Female</topic><topic>Fibrin</topic><topic>Fibrinogen - economics</topic><topic>Fibrinogen - therapeutic use</topic><topic>Health Care Costs</topic><topic>Humans</topic><topic>Length of Stay</topic><topic>Lymph Node Excision - adverse effects</topic><topic>Lymph Node Excision - economics</topic><topic>Lymphatic drainage</topic><topic>Mastectomy</topic><topic>Mastectomy, Segmental</topic><topic>Medicine</topic><topic>Medicine & Public Health</topic><topic>Middle Aged</topic><topic>Morbidity</topic><topic>Oncology</topic><topic>Pain</topic><topic>Pain, Postoperative - etiology</topic><topic>Quality of life</topic><topic>Surgery</topic><topic>Surgical Oncology</topic><topic>Thrombin - economics</topic><topic>Thrombin - therapeutic use</topic><topic>Wound Closure Techniques - economics</topic><topic>Wound Closure Techniques - instrumentation</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Weber, Walter Paul</creatorcontrib><creatorcontrib>Tausch, Christoph</creatorcontrib><creatorcontrib>Hayoz, Stefanie</creatorcontrib><creatorcontrib>Fehr, Mathias Konrad</creatorcontrib><creatorcontrib>Ribi, Karin</creatorcontrib><creatorcontrib>Hawle, Hanne</creatorcontrib><creatorcontrib>Lupatsch, Judith Eva</creatorcontrib><creatorcontrib>Matter-Walstra, Klazien</creatorcontrib><creatorcontrib>Chiesa, Federica</creatorcontrib><creatorcontrib>Dedes, Konstantin Johannes</creatorcontrib><creatorcontrib>Berclaz, Gilles</creatorcontrib><creatorcontrib>Lelièvre, Loic</creatorcontrib><creatorcontrib>Hess, Thomas</creatorcontrib><creatorcontrib>Güth, Uwe</creatorcontrib><creatorcontrib>Pioch, Verena</creatorcontrib><creatorcontrib>Sarlos, Dimitri</creatorcontrib><creatorcontrib>Leo, Cornelia</creatorcontrib><creatorcontrib>Canonica, Claudia</creatorcontrib><creatorcontrib>Gabriel, Natalie</creatorcontrib><creatorcontrib>Zeindler, Jasmin</creatorcontrib><creatorcontrib>Cassoly, Estelle</creatorcontrib><creatorcontrib>Andrieu, Christiane</creatorcontrib><creatorcontrib>Soysal, Savas Deniz</creatorcontrib><creatorcontrib>Ruhstaller, Thomas</creatorcontrib><creatorcontrib>Fehr, Peter Martin</creatorcontrib><creatorcontrib>Knauer, Michael</creatorcontrib><creatorcontrib>Swiss Group for Clinical Cancer Research (SAKK)</creatorcontrib><creatorcontrib>for the Swiss Group for Clinical Cancer Research (SAKK)</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Oncogenes and Growth Factors Abstracts</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>ProQuest Pharma Collection</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central</collection><collection>ProQuest One Community College</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>MEDLINE - Academic</collection><jtitle>Annals of surgical oncology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Weber, Walter Paul</au><au>Tausch, Christoph</au><au>Hayoz, Stefanie</au><au>Fehr, Mathias Konrad</au><au>Ribi, Karin</au><au>Hawle, Hanne</au><au>Lupatsch, Judith Eva</au><au>Matter-Walstra, Klazien</au><au>Chiesa, Federica</au><au>Dedes, Konstantin Johannes</au><au>Berclaz, Gilles</au><au>Lelièvre, Loic</au><au>Hess, Thomas</au><au>Güth, Uwe</au><au>Pioch, Verena</au><au>Sarlos, Dimitri</au><au>Leo, Cornelia</au><au>Canonica, Claudia</au><au>Gabriel, Natalie</au><au>Zeindler, Jasmin</au><au>Cassoly, Estelle</au><au>Andrieu, Christiane</au><au>Soysal, Savas Deniz</au><au>Ruhstaller, Thomas</au><au>Fehr, Peter Martin</au><au>Knauer, Michael</au><aucorp>Swiss Group for Clinical Cancer Research (SAKK)</aucorp><aucorp>for the Swiss Group for Clinical Cancer Research (SAKK)</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Impact of a Surgical Sealing Patch on Lymphatic Drainage After Axillary Dissection for Breast Cancer: The SAKK 23/13 Multicenter Randomized Phase III Trial</atitle><jtitle>Annals of surgical oncology</jtitle><stitle>Ann Surg Oncol</stitle><addtitle>Ann Surg Oncol</addtitle><date>2018-09-01</date><risdate>2018</risdate><volume>25</volume><issue>9</issue><spage>2632</spage><epage>2640</epage><pages>2632-2640</pages><issn>1068-9265</issn><eissn>1534-4681</eissn><abstract>Background
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.
Methods
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
®
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.
Results
Between March 2015 and December 2016, 142 patients were randomized (72 with TachoSil
®
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
®
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
®
. 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
®
and 33,365 Swiss Francs (95% CI 31,771–34,961) without,
p
= 0.584]. In the TachoSil
®
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].
Conclusions
TachoSil
®
reduced drainage after axillary dissection for breast cancer neither significantly nor relevantly.</abstract><cop>Cham</cop><pub>Springer International Publishing</pub><pmid>29948418</pmid><doi>10.1245/s10434-018-6556-9</doi><tpages>9</tpages></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 1068-9265 |
| ispartof | Annals of surgical oncology, 2018-09, Vol.25 (9), p.2632-2640 |
| issn | 1068-9265 1534-4681 |
| language | eng |
| recordid | cdi_proquest_miscellaneous_2060867449 |
| source | MEDLINE; SpringerLink Journals |
| subjects | Aged Axilla Biopsy Breast cancer Breast Neoplasms - pathology Breast Neoplasms - surgery Breast Oncology Dissection Drainage Drug Combinations Female Fibrin Fibrinogen - economics Fibrinogen - therapeutic use Health Care Costs Humans Length of Stay Lymph Node Excision - adverse effects Lymph Node Excision - economics Lymphatic drainage Mastectomy Mastectomy, Segmental Medicine Medicine & Public Health Middle Aged Morbidity Oncology Pain Pain, Postoperative - etiology Quality of life Surgery Surgical Oncology Thrombin - economics Thrombin - therapeutic use Wound Closure Techniques - economics Wound Closure Techniques - instrumentation |
| 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 |
| url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2025-01-18T08%3A50%3A22IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-proquest_cross&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Impact%20of%20a%20Surgical%20Sealing%20Patch%20on%20Lymphatic%20Drainage%20After%20Axillary%20Dissection%20for%20Breast%20Cancer:%20The%20SAKK%2023/13%20Multicenter%20Randomized%20Phase%20III%20Trial&rft.jtitle=Annals%20of%20surgical%20oncology&rft.au=Weber,%20Walter%20Paul&rft.aucorp=Swiss%20Group%20for%20Clinical%20Cancer%20Research%20(SAKK)&rft.date=2018-09-01&rft.volume=25&rft.issue=9&rft.spage=2632&rft.epage=2640&rft.pages=2632-2640&rft.issn=1068-9265&rft.eissn=1534-4681&rft_id=info:doi/10.1245/s10434-018-6556-9&rft_dat=%3Cproquest_cross%3E2052550334%3C/proquest_cross%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_pqid=2052550334&rft_id=info:pmid/29948418&rfr_iscdi=true |