Biomolecular inflammatory response to surgical energy usage in laparoscopic surgery: results of a randomized study
Objective Use of surgical energy is integral to laparoscopic surgery (LS). Energized dissection (ED) has a potential to impact the biomolecular expression of inflammation due to ED-induced collateral inflammation. We did this triple-blind randomized controlled (RCT) study to assess this biomolecular...
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| description | Objective
Use of surgical energy is integral to laparoscopic surgery (LS). Energized dissection (ED) has a potential to impact the biomolecular expression of inflammation due to ED-induced collateral inflammation. We did this triple-blind randomized controlled (RCT) study to assess this biomolecular footprint in an index LS, i.e., laparoscopic cholecystectomy (LC).
Methods and procedures
This RCT was conducted in collaboration with tertiary-level institutions, from January 2014 to December 2014 with institutional review board clearance. Consecutive, unselected, consenting candidates for LC were randomized (after anesthesia induction) into group I (ED) and group II (non-ED). They were managed with compliance to universal protocols for ethics, informed consent, anesthesia, drug usage and clinical pathway with blinded observers. Biomolecular inflammatory markers, i.e., interleukin 6 (IL-6), tumor necrosis factor-alpha (TNF-α) and highly sensitive CRP (HS-CRP), were measured with blood drawn juxta-preoperatively (H0), at 4 h (H4) and at 24 h (H24). The quantitative changes induced by ED on IL-6, TNF-α and HS-CRP at H0, H4 and H24 with their kinetic behavior were the study endpoint. Prospective data were analyzed statistically with a
p
value of |
| doi_str_mv | 10.1007/s00464-015-4408-2 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_miscellaneous_1785733427</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>1785733427</sourcerecordid><originalsourceid>FETCH-LOGICAL-c372t-430111419d5341205db3b8dcc729c7a576034c4b154066005eaf1baff00c548b3</originalsourceid><addsrcrecordid>eNp10T1v1TAUBmALgeht4QewIEssLIFz_BEnbLSCUqkSSztbjuNcpXLiYMdD-utxuAUhJCYPft7jj5eQNwgfEEB9TACiFhWgrISApmLPyAEFZxVj2DwnB2g5VEy14oycp_QAhbcoX5IzVmMrmOQHEi_HMAXvbPYm0nEevJkms4a40ejSEubk6BpoyvE4WuOpm108bjQnc3SFU28WE0OyYRntL-Xi9mmPZr8mGgZqaDRzH6bx0fU0rbnfXpEXg_HJvX5aL8j91y93V9-q2-_XN1efbyvLFVsrwQERBba95AIZyL7jXdNbq1hrlZGqBi6s6FAKqGsA6cyAnRkGACtF0_EL8v40d4nhR3Zp1dOYrPPezC7kpFE1UnEumCr03T_0IeQ4l9vtStSF1bvCk7LlxSm6QS9xnEzcNILeC9GnQnQpRO-FaFYyb58m525y_Z_E7wYKYCeQytZcvu-vo_879Scnj5aO</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>1784673367</pqid></control><display><type>article</type><title>Biomolecular inflammatory response to surgical energy usage in laparoscopic surgery: results of a randomized study</title><source>MEDLINE</source><source>Springer Nature - Complete Springer Journals</source><creator>Agarwal, Brij B. ; Nanavati, Juhil D. ; Agarwal, Nayan ; Sharma, Naveen ; Agarwal, Krishna A. ; Manish, Kumar ; Saluja, Satish ; Agarwal, Sneh</creator><creatorcontrib>Agarwal, Brij B. ; Nanavati, Juhil D. ; Agarwal, Nayan ; Sharma, Naveen ; Agarwal, Krishna A. ; Manish, Kumar ; Saluja, Satish ; Agarwal, Sneh</creatorcontrib><description>Objective
Use of surgical energy is integral to laparoscopic surgery (LS). Energized dissection (ED) has a potential to impact the biomolecular expression of inflammation due to ED-induced collateral inflammation. We did this triple-blind randomized controlled (RCT) study to assess this biomolecular footprint in an index LS, i.e., laparoscopic cholecystectomy (LC).
Methods and procedures
This RCT was conducted in collaboration with tertiary-level institutions, from January 2014 to December 2014 with institutional review board clearance. Consecutive, unselected, consenting candidates for LC were randomized (after anesthesia induction) into group I (ED) and group II (non-ED). They were managed with compliance to universal protocols for ethics, informed consent, anesthesia, drug usage and clinical pathway with blinded observers. Biomolecular inflammatory markers, i.e., interleukin 6 (IL-6), tumor necrosis factor-alpha (TNF-α) and highly sensitive CRP (HS-CRP), were measured with blood drawn juxta-preoperatively (H0), at 4 h (H4) and at 24 h (H24). The quantitative changes induced by ED on IL-6, TNF-α and HS-CRP at H0, H4 and H24 with their kinetic behavior were the study endpoint. Prospective data were analyzed statistically with a
p
value of <0.05 being significant.
Results
Two cases from the ED group had biliary injury and hence were withdrawn from analysis. The ED (
n
= 49) and non-ED (
n
= 51) groups had similar demographic, clinical and H0 biomolecular variables. There was a significant increase in IL-6, TNF-α and HS-CRP from H0 to H4 in both the groups (
p
values <0.001). From H4 to H24, all three cytokines showed significant increase in ED group (
p
< 0.05), whereas in the non-ED group, IL-6 showed significant fall (
p
= 0.004) and TNF-α showed no significant change (
p
= 0.063). Both the groups showed H4–H24 elevation of HS-CRP (p = 0.000).
Conclusion
Energized dissection adds to the cytokine-mediated postoperative inflammation. The additional ED-induced inflammation can be measured objectively by IL-6 and TNF-α levels.
Clinical trials registry
Clinical Trials Registry, India (REF/2014/06/007153).</description><identifier>ISSN: 0930-2794</identifier><identifier>EISSN: 1432-2218</identifier><identifier>DOI: 10.1007/s00464-015-4408-2</identifier><identifier>PMID: 26194253</identifier><language>eng</language><publisher>New York: Springer US</publisher><subject>Abdominal Surgery ; Adult ; Aged ; Biomarkers - blood ; C-Reactive Protein - metabolism ; Cholecystectomy ; Cholecystectomy, Laparoscopic - adverse effects ; Cholecystectomy, Laparoscopic - methods ; Clinical trials ; Collaboration ; Cytokines ; Dissection ; Dissection - adverse effects ; Dissection - methods ; Double-Blind Method ; Electrosurgery - adverse effects ; Electrosurgery - methods ; Energy ; Female ; Gastroenterology ; Gynecology ; Hepatology ; Humans ; Inflammation - blood ; Inflammation - diagnosis ; Inflammation - etiology ; Interleukin-6 - blood ; Laparoscopy ; Male ; Medical education ; Medicine ; Medicine & Public Health ; Middle Aged ; Outcome Assessment (Health Care) ; Postoperative Complications - blood ; Postoperative Complications - diagnosis ; Postoperative Complications - etiology ; Postoperative Period ; Proctology ; Prospective Studies ; Surgery ; Tumor Necrosis Factor-alpha - blood ; Tumor necrosis factor-TNF</subject><ispartof>Surgical endoscopy, 2016-05, Vol.30 (5), p.1733-1741</ispartof><rights>Springer Science+Business Media New York 2015</rights><rights>Springer Science+Business Media New York 2016</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c372t-430111419d5341205db3b8dcc729c7a576034c4b154066005eaf1baff00c548b3</citedby><cites>FETCH-LOGICAL-c372t-430111419d5341205db3b8dcc729c7a576034c4b154066005eaf1baff00c548b3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://link.springer.com/content/pdf/10.1007/s00464-015-4408-2$$EPDF$$P50$$Gspringer$$H</linktopdf><linktohtml>$$Uhttps://link.springer.com/10.1007/s00464-015-4408-2$$EHTML$$P50$$Gspringer$$H</linktohtml><link.rule.ids>314,776,780,27903,27904,41467,42536,51297</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/26194253$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Agarwal, Brij B.</creatorcontrib><creatorcontrib>Nanavati, Juhil D.</creatorcontrib><creatorcontrib>Agarwal, Nayan</creatorcontrib><creatorcontrib>Sharma, Naveen</creatorcontrib><creatorcontrib>Agarwal, Krishna A.</creatorcontrib><creatorcontrib>Manish, Kumar</creatorcontrib><creatorcontrib>Saluja, Satish</creatorcontrib><creatorcontrib>Agarwal, Sneh</creatorcontrib><title>Biomolecular inflammatory response to surgical energy usage in laparoscopic surgery: results of a randomized study</title><title>Surgical endoscopy</title><addtitle>Surg Endosc</addtitle><addtitle>Surg Endosc</addtitle><description>Objective
Use of surgical energy is integral to laparoscopic surgery (LS). Energized dissection (ED) has a potential to impact the biomolecular expression of inflammation due to ED-induced collateral inflammation. We did this triple-blind randomized controlled (RCT) study to assess this biomolecular footprint in an index LS, i.e., laparoscopic cholecystectomy (LC).
Methods and procedures
This RCT was conducted in collaboration with tertiary-level institutions, from January 2014 to December 2014 with institutional review board clearance. Consecutive, unselected, consenting candidates for LC were randomized (after anesthesia induction) into group I (ED) and group II (non-ED). They were managed with compliance to universal protocols for ethics, informed consent, anesthesia, drug usage and clinical pathway with blinded observers. Biomolecular inflammatory markers, i.e., interleukin 6 (IL-6), tumor necrosis factor-alpha (TNF-α) and highly sensitive CRP (HS-CRP), were measured with blood drawn juxta-preoperatively (H0), at 4 h (H4) and at 24 h (H24). The quantitative changes induced by ED on IL-6, TNF-α and HS-CRP at H0, H4 and H24 with their kinetic behavior were the study endpoint. Prospective data were analyzed statistically with a
p
value of <0.05 being significant.
Results
Two cases from the ED group had biliary injury and hence were withdrawn from analysis. The ED (
n
= 49) and non-ED (
n
= 51) groups had similar demographic, clinical and H0 biomolecular variables. There was a significant increase in IL-6, TNF-α and HS-CRP from H0 to H4 in both the groups (
p
values <0.001). From H4 to H24, all three cytokines showed significant increase in ED group (
p
< 0.05), whereas in the non-ED group, IL-6 showed significant fall (
p
= 0.004) and TNF-α showed no significant change (
p
= 0.063). Both the groups showed H4–H24 elevation of HS-CRP (p = 0.000).
Conclusion
Energized dissection adds to the cytokine-mediated postoperative inflammation. The additional ED-induced inflammation can be measured objectively by IL-6 and TNF-α levels.
Clinical trials registry
Clinical Trials Registry, India (REF/2014/06/007153).</description><subject>Abdominal Surgery</subject><subject>Adult</subject><subject>Aged</subject><subject>Biomarkers - blood</subject><subject>C-Reactive Protein - metabolism</subject><subject>Cholecystectomy</subject><subject>Cholecystectomy, Laparoscopic - adverse effects</subject><subject>Cholecystectomy, Laparoscopic - methods</subject><subject>Clinical trials</subject><subject>Collaboration</subject><subject>Cytokines</subject><subject>Dissection</subject><subject>Dissection - adverse effects</subject><subject>Dissection - methods</subject><subject>Double-Blind Method</subject><subject>Electrosurgery - adverse effects</subject><subject>Electrosurgery - methods</subject><subject>Energy</subject><subject>Female</subject><subject>Gastroenterology</subject><subject>Gynecology</subject><subject>Hepatology</subject><subject>Humans</subject><subject>Inflammation - blood</subject><subject>Inflammation - diagnosis</subject><subject>Inflammation - etiology</subject><subject>Interleukin-6 - blood</subject><subject>Laparoscopy</subject><subject>Male</subject><subject>Medical education</subject><subject>Medicine</subject><subject>Medicine & Public Health</subject><subject>Middle Aged</subject><subject>Outcome Assessment (Health Care)</subject><subject>Postoperative Complications - blood</subject><subject>Postoperative Complications - diagnosis</subject><subject>Postoperative Complications - etiology</subject><subject>Postoperative Period</subject><subject>Proctology</subject><subject>Prospective Studies</subject><subject>Surgery</subject><subject>Tumor Necrosis Factor-alpha - blood</subject><subject>Tumor necrosis factor-TNF</subject><issn>0930-2794</issn><issn>1432-2218</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2016</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><recordid>eNp10T1v1TAUBmALgeht4QewIEssLIFz_BEnbLSCUqkSSztbjuNcpXLiYMdD-utxuAUhJCYPft7jj5eQNwgfEEB9TACiFhWgrISApmLPyAEFZxVj2DwnB2g5VEy14oycp_QAhbcoX5IzVmMrmOQHEi_HMAXvbPYm0nEevJkms4a40ejSEubk6BpoyvE4WuOpm108bjQnc3SFU28WE0OyYRntL-Xi9mmPZr8mGgZqaDRzH6bx0fU0rbnfXpEXg_HJvX5aL8j91y93V9-q2-_XN1efbyvLFVsrwQERBba95AIZyL7jXdNbq1hrlZGqBi6s6FAKqGsA6cyAnRkGACtF0_EL8v40d4nhR3Zp1dOYrPPezC7kpFE1UnEumCr03T_0IeQ4l9vtStSF1bvCk7LlxSm6QS9xnEzcNILeC9GnQnQpRO-FaFYyb58m525y_Z_E7wYKYCeQytZcvu-vo_879Scnj5aO</recordid><startdate>20160501</startdate><enddate>20160501</enddate><creator>Agarwal, Brij B.</creator><creator>Nanavati, Juhil D.</creator><creator>Agarwal, Nayan</creator><creator>Sharma, Naveen</creator><creator>Agarwal, Krishna A.</creator><creator>Manish, Kumar</creator><creator>Saluja, Satish</creator><creator>Agarwal, Sneh</creator><general>Springer US</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>7RV</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>K9.</scope><scope>KB0</scope><scope>M0S</scope><scope>M1P</scope><scope>NAPCQ</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>7X8</scope></search><sort><creationdate>20160501</creationdate><title>Biomolecular inflammatory response to surgical energy usage in laparoscopic surgery: results of a randomized study</title><author>Agarwal, Brij B. ; Nanavati, Juhil D. ; Agarwal, Nayan ; Sharma, Naveen ; Agarwal, Krishna A. ; Manish, Kumar ; Saluja, Satish ; Agarwal, Sneh</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c372t-430111419d5341205db3b8dcc729c7a576034c4b154066005eaf1baff00c548b3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2016</creationdate><topic>Abdominal Surgery</topic><topic>Adult</topic><topic>Aged</topic><topic>Biomarkers - blood</topic><topic>C-Reactive Protein - metabolism</topic><topic>Cholecystectomy</topic><topic>Cholecystectomy, Laparoscopic - adverse effects</topic><topic>Cholecystectomy, Laparoscopic - methods</topic><topic>Clinical trials</topic><topic>Collaboration</topic><topic>Cytokines</topic><topic>Dissection</topic><topic>Dissection - adverse effects</topic><topic>Dissection - methods</topic><topic>Double-Blind Method</topic><topic>Electrosurgery - adverse effects</topic><topic>Electrosurgery - methods</topic><topic>Energy</topic><topic>Female</topic><topic>Gastroenterology</topic><topic>Gynecology</topic><topic>Hepatology</topic><topic>Humans</topic><topic>Inflammation - blood</topic><topic>Inflammation - diagnosis</topic><topic>Inflammation - etiology</topic><topic>Interleukin-6 - blood</topic><topic>Laparoscopy</topic><topic>Male</topic><topic>Medical education</topic><topic>Medicine</topic><topic>Medicine & Public Health</topic><topic>Middle Aged</topic><topic>Outcome Assessment (Health Care)</topic><topic>Postoperative Complications - blood</topic><topic>Postoperative Complications - diagnosis</topic><topic>Postoperative Complications - etiology</topic><topic>Postoperative Period</topic><topic>Proctology</topic><topic>Prospective Studies</topic><topic>Surgery</topic><topic>Tumor Necrosis Factor-alpha - blood</topic><topic>Tumor necrosis factor-TNF</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Agarwal, Brij B.</creatorcontrib><creatorcontrib>Nanavati, Juhil D.</creatorcontrib><creatorcontrib>Agarwal, Nayan</creatorcontrib><creatorcontrib>Sharma, Naveen</creatorcontrib><creatorcontrib>Agarwal, Krishna A.</creatorcontrib><creatorcontrib>Manish, Kumar</creatorcontrib><creatorcontrib>Saluja, Satish</creatorcontrib><creatorcontrib>Agarwal, Sneh</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>Nursing & Allied Health Database</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>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Database (Alumni Edition)</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>Nursing & Allied Health Premium</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>Surgical endoscopy</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Agarwal, Brij B.</au><au>Nanavati, Juhil D.</au><au>Agarwal, Nayan</au><au>Sharma, Naveen</au><au>Agarwal, Krishna A.</au><au>Manish, Kumar</au><au>Saluja, Satish</au><au>Agarwal, Sneh</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Biomolecular inflammatory response to surgical energy usage in laparoscopic surgery: results of a randomized study</atitle><jtitle>Surgical endoscopy</jtitle><stitle>Surg Endosc</stitle><addtitle>Surg Endosc</addtitle><date>2016-05-01</date><risdate>2016</risdate><volume>30</volume><issue>5</issue><spage>1733</spage><epage>1741</epage><pages>1733-1741</pages><issn>0930-2794</issn><eissn>1432-2218</eissn><abstract>Objective
Use of surgical energy is integral to laparoscopic surgery (LS). Energized dissection (ED) has a potential to impact the biomolecular expression of inflammation due to ED-induced collateral inflammation. We did this triple-blind randomized controlled (RCT) study to assess this biomolecular footprint in an index LS, i.e., laparoscopic cholecystectomy (LC).
Methods and procedures
This RCT was conducted in collaboration with tertiary-level institutions, from January 2014 to December 2014 with institutional review board clearance. Consecutive, unselected, consenting candidates for LC were randomized (after anesthesia induction) into group I (ED) and group II (non-ED). They were managed with compliance to universal protocols for ethics, informed consent, anesthesia, drug usage and clinical pathway with blinded observers. Biomolecular inflammatory markers, i.e., interleukin 6 (IL-6), tumor necrosis factor-alpha (TNF-α) and highly sensitive CRP (HS-CRP), were measured with blood drawn juxta-preoperatively (H0), at 4 h (H4) and at 24 h (H24). The quantitative changes induced by ED on IL-6, TNF-α and HS-CRP at H0, H4 and H24 with their kinetic behavior were the study endpoint. Prospective data were analyzed statistically with a
p
value of <0.05 being significant.
Results
Two cases from the ED group had biliary injury and hence were withdrawn from analysis. The ED (
n
= 49) and non-ED (
n
= 51) groups had similar demographic, clinical and H0 biomolecular variables. There was a significant increase in IL-6, TNF-α and HS-CRP from H0 to H4 in both the groups (
p
values <0.001). From H4 to H24, all three cytokines showed significant increase in ED group (
p
< 0.05), whereas in the non-ED group, IL-6 showed significant fall (
p
= 0.004) and TNF-α showed no significant change (
p
= 0.063). Both the groups showed H4–H24 elevation of HS-CRP (p = 0.000).
Conclusion
Energized dissection adds to the cytokine-mediated postoperative inflammation. The additional ED-induced inflammation can be measured objectively by IL-6 and TNF-α levels.
Clinical trials registry
Clinical Trials Registry, India (REF/2014/06/007153).</abstract><cop>New York</cop><pub>Springer US</pub><pmid>26194253</pmid><doi>10.1007/s00464-015-4408-2</doi><tpages>9</tpages></addata></record> |
| fulltext | fulltext |
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| ispartof | Surgical endoscopy, 2016-05, Vol.30 (5), p.1733-1741 |
| issn | 0930-2794 1432-2218 |
| language | eng |
| recordid | cdi_proquest_miscellaneous_1785733427 |
| source | MEDLINE; Springer Nature - Complete Springer Journals |
| subjects | Abdominal Surgery Adult Aged Biomarkers - blood C-Reactive Protein - metabolism Cholecystectomy Cholecystectomy, Laparoscopic - adverse effects Cholecystectomy, Laparoscopic - methods Clinical trials Collaboration Cytokines Dissection Dissection - adverse effects Dissection - methods Double-Blind Method Electrosurgery - adverse effects Electrosurgery - methods Energy Female Gastroenterology Gynecology Hepatology Humans Inflammation - blood Inflammation - diagnosis Inflammation - etiology Interleukin-6 - blood Laparoscopy Male Medical education Medicine Medicine & Public Health Middle Aged Outcome Assessment (Health Care) Postoperative Complications - blood Postoperative Complications - diagnosis Postoperative Complications - etiology Postoperative Period Proctology Prospective Studies Surgery Tumor Necrosis Factor-alpha - blood Tumor necrosis factor-TNF |
| title | Biomolecular inflammatory response to surgical energy usage in laparoscopic surgery: results of a randomized study |
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