A comparison of surgical devices for grade II and III hemorrhoidal disease. Results from the LigaLongo Trial comparing transanal Doppler-guided hemorrhoidal artery ligation with mucopexy and circular stapled hemorrhoidopexy

Purpose Little is presently known on the impact of device type for Doppler-guided hemorrhoidal artery ligation/mucopexy (DGHAL) or circular stapled hemorrhoidopexy (CSH) when a surgical treatment is considered for hemorrhoidal disease (HD). In this study, we aimed to compare the outcome in terms of...

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Veröffentlicht in:International journal of colorectal disease 2018-10, Vol.33 (10), p.1479-1483
Hauptverfasser: Venara, Aurelien, Podevin, Juliette, Godeberge, Philippe, Redon, Yann, Barussaud, Marie-Line, Sielezneff, Igor, Queralto, Michel, Bourbao, Cecile, Chiffoleau, Anne, Lehur, Paul A
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container_issue 10
container_start_page 1479
container_title International journal of colorectal disease
container_volume 33
creator Venara, Aurelien
Podevin, Juliette
Godeberge, Philippe
Redon, Yann
Barussaud, Marie-Line
Sielezneff, Igor
Queralto, Michel
Bourbao, Cecile
Chiffoleau, Anne
Lehur, Paul A
description Purpose Little is presently known on the impact of device type for Doppler-guided hemorrhoidal artery ligation/mucopexy (DGHAL) or circular stapled hemorrhoidopexy (CSH) when a surgical treatment is considered for hemorrhoidal disease (HD). In this study, we aimed to compare the outcome in terms of adverse events and recurrence rate, of patients included in the multicenter LigaLongo RCT ( ClinicalTrials.gov NCT01240772) according to the type of devices used. Methods In the DGHAL arm ( N  = 193), the procedure was done with transanal hemorrhoidal dearterialization (THD)™ (THD, Correggio, Italy) (104 patients) and with HAL-RAR™ (Agency for Medical Innovations (AMI) GmbH, Feldkirch, Austria) (89 patients). In the CSH arm ( N  = 184), procedure for prolapse and hemorrhoids (PPH)-03™ (Ethicon Endo-Surgery, Cincinnati OH) and hemorrhoidopexy and prolapse (HEM)™ (Covidien, Inc.) staplers were used in respectively 106 and 78 cases. Surgery-related morbidity at 90 postoperative days (POD) based on the Clavien-Dindo procedure-related complication score and clinical outcome in terms of recurrence and reoperation rate at 12 postoperative months (POM) was collected. Results Three hundred and seventy-seven patients were randomized according to HD grade. In the DGHAL arm, the number of ligations and mucopexies was higher in the AMI group ( p  
doi_str_mv 10.1007/s00384-018-3093-8
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Results from the LigaLongo Trial comparing transanal Doppler-guided hemorrhoidal artery ligation with mucopexy and circular stapled hemorrhoidopexy</title><source>MEDLINE</source><source>SpringerLink Journals</source><creator>Venara, Aurelien ; Podevin, Juliette ; Godeberge, Philippe ; Redon, Yann ; Barussaud, Marie-Line ; Sielezneff, Igor ; Queralto, Michel ; Bourbao, Cecile ; Chiffoleau, Anne ; Lehur, Paul A</creator><creatorcontrib>Venara, Aurelien ; Podevin, Juliette ; Godeberge, Philippe ; Redon, Yann ; Barussaud, Marie-Line ; Sielezneff, Igor ; Queralto, Michel ; Bourbao, Cecile ; Chiffoleau, Anne ; Lehur, Paul A ; LigaLongo Study Group ; on behalf of the LigaLongo Study Group</creatorcontrib><description>Purpose Little is presently known on the impact of device type for Doppler-guided hemorrhoidal artery ligation/mucopexy (DGHAL) or circular stapled hemorrhoidopexy (CSH) when a surgical treatment is considered for hemorrhoidal disease (HD). In this study, we aimed to compare the outcome in terms of adverse events and recurrence rate, of patients included in the multicenter LigaLongo RCT ( ClinicalTrials.gov NCT01240772) according to the type of devices used. Methods In the DGHAL arm ( N  = 193), the procedure was done with transanal hemorrhoidal dearterialization (THD)™ (THD, Correggio, Italy) (104 patients) and with HAL-RAR™ (Agency for Medical Innovations (AMI) GmbH, Feldkirch, Austria) (89 patients). In the CSH arm ( N  = 184), procedure for prolapse and hemorrhoids (PPH)-03™ (Ethicon Endo-Surgery, Cincinnati OH) and hemorrhoidopexy and prolapse (HEM)™ (Covidien, Inc.) staplers were used in respectively 106 and 78 cases. Surgery-related morbidity at 90 postoperative days (POD) based on the Clavien-Dindo procedure-related complication score and clinical outcome in terms of recurrence and reoperation rate at 12 postoperative months (POM) was collected. Results Three hundred and seventy-seven patients were randomized according to HD grade. In the DGHAL arm, the number of ligations and mucopexies was higher in the AMI group ( p  &lt; 0.0001); at 90 POD, the overall morbidity was similar between the two groups. In the CSH arm, donut sizes were similar; at 90 POD, the PPH group had a higher risk of postoperative grade 1 morbidity (anal urgency or incontinence) compared to the HEM group ( p  = 0.003). At 12 POM, no statistical difference was found between the two groups of each arm in terms of grade III recurrence or reoperation. Conclusion Postoperative morbidity and outcome at 1 year were similar regardless of the type of devices used. These findings suggest that device type has little impact on HD treatment results. Trial registration clinicaltrials.gov —Identifier NCT01240772</description><identifier>ISSN: 0179-1958</identifier><identifier>ISSN: 1432-1262</identifier><identifier>EISSN: 1432-1262</identifier><identifier>DOI: 10.1007/s00384-018-3093-8</identifier><identifier>PMID: 29808305</identifier><language>eng</language><publisher>Berlin/Heidelberg: Springer Berlin Heidelberg</publisher><subject>Adult ; Arteries - surgery ; Comparative analysis ; Digestive System Surgical Procedures - instrumentation ; Digestive System Surgical Procedures - methods ; Gastroenterology ; Hemorrhoids ; Hemorrhoids - surgery ; Hepatology ; Humans ; Internal Medicine ; Life Sciences ; Ligation ; Medical equipment ; Medical innovations ; Medicine ; Medicine &amp; Public Health ; Morbidity ; Original Article ; Patients ; Physiological apparatus ; Proctology ; Rectum ; Surgery ; Sutures ; Treatment Outcome ; Varicose veins</subject><ispartof>International journal of colorectal disease, 2018-10, Vol.33 (10), p.1479-1483</ispartof><rights>Springer-Verlag GmbH Germany, part of Springer Nature 2018</rights><rights>COPYRIGHT 2018 Springer</rights><rights>International Journal of Colorectal Disease is a copyright of Springer, (2018). All Rights Reserved.</rights><rights>Distributed under a Creative Commons Attribution 4.0 International License</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c473t-fb31a7d3df025db0e2f64ff008905537aba326344abe72bbb755de845f0a8ebe3</citedby><cites>FETCH-LOGICAL-c473t-fb31a7d3df025db0e2f64ff008905537aba326344abe72bbb755de845f0a8ebe3</cites><orcidid>0000-0003-1539-4797</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://link.springer.com/content/pdf/10.1007/s00384-018-3093-8$$EPDF$$P50$$Gspringer$$H</linktopdf><linktohtml>$$Uhttps://link.springer.com/10.1007/s00384-018-3093-8$$EHTML$$P50$$Gspringer$$H</linktohtml><link.rule.ids>230,314,776,780,881,27901,27902,41464,42533,51294</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/29808305$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink><backlink>$$Uhttps://univ-angers.hal.science/hal-02648443$$DView record in HAL$$Hfree_for_read</backlink></links><search><creatorcontrib>Venara, Aurelien</creatorcontrib><creatorcontrib>Podevin, Juliette</creatorcontrib><creatorcontrib>Godeberge, Philippe</creatorcontrib><creatorcontrib>Redon, Yann</creatorcontrib><creatorcontrib>Barussaud, Marie-Line</creatorcontrib><creatorcontrib>Sielezneff, Igor</creatorcontrib><creatorcontrib>Queralto, Michel</creatorcontrib><creatorcontrib>Bourbao, Cecile</creatorcontrib><creatorcontrib>Chiffoleau, Anne</creatorcontrib><creatorcontrib>Lehur, Paul A</creatorcontrib><creatorcontrib>LigaLongo Study Group</creatorcontrib><creatorcontrib>on behalf of the LigaLongo Study Group</creatorcontrib><title>A comparison of surgical devices for grade II and III hemorrhoidal disease. Results from the LigaLongo Trial comparing transanal Doppler-guided hemorrhoidal artery ligation with mucopexy and circular stapled hemorrhoidopexy</title><title>International journal of colorectal disease</title><addtitle>Int J Colorectal Dis</addtitle><addtitle>Int J Colorectal Dis</addtitle><description>Purpose Little is presently known on the impact of device type for Doppler-guided hemorrhoidal artery ligation/mucopexy (DGHAL) or circular stapled hemorrhoidopexy (CSH) when a surgical treatment is considered for hemorrhoidal disease (HD). In this study, we aimed to compare the outcome in terms of adverse events and recurrence rate, of patients included in the multicenter LigaLongo RCT ( ClinicalTrials.gov NCT01240772) according to the type of devices used. Methods In the DGHAL arm ( N  = 193), the procedure was done with transanal hemorrhoidal dearterialization (THD)™ (THD, Correggio, Italy) (104 patients) and with HAL-RAR™ (Agency for Medical Innovations (AMI) GmbH, Feldkirch, Austria) (89 patients). In the CSH arm ( N  = 184), procedure for prolapse and hemorrhoids (PPH)-03™ (Ethicon Endo-Surgery, Cincinnati OH) and hemorrhoidopexy and prolapse (HEM)™ (Covidien, Inc.) staplers were used in respectively 106 and 78 cases. Surgery-related morbidity at 90 postoperative days (POD) based on the Clavien-Dindo procedure-related complication score and clinical outcome in terms of recurrence and reoperation rate at 12 postoperative months (POM) was collected. Results Three hundred and seventy-seven patients were randomized according to HD grade. In the DGHAL arm, the number of ligations and mucopexies was higher in the AMI group ( p  &lt; 0.0001); at 90 POD, the overall morbidity was similar between the two groups. In the CSH arm, donut sizes were similar; at 90 POD, the PPH group had a higher risk of postoperative grade 1 morbidity (anal urgency or incontinence) compared to the HEM group ( p  = 0.003). At 12 POM, no statistical difference was found between the two groups of each arm in terms of grade III recurrence or reoperation. Conclusion Postoperative morbidity and outcome at 1 year were similar regardless of the type of devices used. These findings suggest that device type has little impact on HD treatment results. 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Results from the LigaLongo Trial comparing transanal Doppler-guided hemorrhoidal artery ligation with mucopexy and circular stapled hemorrhoidopexy</title><author>Venara, Aurelien ; Podevin, Juliette ; Godeberge, Philippe ; Redon, Yann ; Barussaud, Marie-Line ; Sielezneff, Igor ; Queralto, Michel ; Bourbao, Cecile ; Chiffoleau, Anne ; Lehur, Paul A</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c473t-fb31a7d3df025db0e2f64ff008905537aba326344abe72bbb755de845f0a8ebe3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2018</creationdate><topic>Adult</topic><topic>Arteries - surgery</topic><topic>Comparative analysis</topic><topic>Digestive System Surgical Procedures - instrumentation</topic><topic>Digestive System Surgical Procedures - methods</topic><topic>Gastroenterology</topic><topic>Hemorrhoids</topic><topic>Hemorrhoids - surgery</topic><topic>Hepatology</topic><topic>Humans</topic><topic>Internal Medicine</topic><topic>Life Sciences</topic><topic>Ligation</topic><topic>Medical equipment</topic><topic>Medical innovations</topic><topic>Medicine</topic><topic>Medicine &amp; Public Health</topic><topic>Morbidity</topic><topic>Original Article</topic><topic>Patients</topic><topic>Physiological apparatus</topic><topic>Proctology</topic><topic>Rectum</topic><topic>Surgery</topic><topic>Sutures</topic><topic>Treatment Outcome</topic><topic>Varicose veins</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Venara, Aurelien</creatorcontrib><creatorcontrib>Podevin, Juliette</creatorcontrib><creatorcontrib>Godeberge, Philippe</creatorcontrib><creatorcontrib>Redon, Yann</creatorcontrib><creatorcontrib>Barussaud, Marie-Line</creatorcontrib><creatorcontrib>Sielezneff, Igor</creatorcontrib><creatorcontrib>Queralto, Michel</creatorcontrib><creatorcontrib>Bourbao, Cecile</creatorcontrib><creatorcontrib>Chiffoleau, Anne</creatorcontrib><creatorcontrib>Lehur, Paul A</creatorcontrib><creatorcontrib>LigaLongo Study Group</creatorcontrib><creatorcontrib>on behalf of the LigaLongo Study Group</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>Immunology Abstracts</collection><collection>Health &amp; 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 &amp; Medical Complete (Alumni)</collection><collection>Health &amp; 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><collection>Hyper Article en Ligne (HAL)</collection><jtitle>International journal of colorectal disease</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Venara, Aurelien</au><au>Podevin, Juliette</au><au>Godeberge, Philippe</au><au>Redon, Yann</au><au>Barussaud, Marie-Line</au><au>Sielezneff, Igor</au><au>Queralto, Michel</au><au>Bourbao, Cecile</au><au>Chiffoleau, Anne</au><au>Lehur, Paul A</au><aucorp>LigaLongo Study Group</aucorp><aucorp>on behalf of the LigaLongo Study Group</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>A comparison of surgical devices for grade II and III hemorrhoidal disease. Results from the LigaLongo Trial comparing transanal Doppler-guided hemorrhoidal artery ligation with mucopexy and circular stapled hemorrhoidopexy</atitle><jtitle>International journal of colorectal disease</jtitle><stitle>Int J Colorectal Dis</stitle><addtitle>Int J Colorectal Dis</addtitle><date>2018-10-01</date><risdate>2018</risdate><volume>33</volume><issue>10</issue><spage>1479</spage><epage>1483</epage><pages>1479-1483</pages><issn>0179-1958</issn><issn>1432-1262</issn><eissn>1432-1262</eissn><abstract>Purpose Little is presently known on the impact of device type for Doppler-guided hemorrhoidal artery ligation/mucopexy (DGHAL) or circular stapled hemorrhoidopexy (CSH) when a surgical treatment is considered for hemorrhoidal disease (HD). In this study, we aimed to compare the outcome in terms of adverse events and recurrence rate, of patients included in the multicenter LigaLongo RCT ( ClinicalTrials.gov NCT01240772) according to the type of devices used. Methods In the DGHAL arm ( N  = 193), the procedure was done with transanal hemorrhoidal dearterialization (THD)™ (THD, Correggio, Italy) (104 patients) and with HAL-RAR™ (Agency for Medical Innovations (AMI) GmbH, Feldkirch, Austria) (89 patients). In the CSH arm ( N  = 184), procedure for prolapse and hemorrhoids (PPH)-03™ (Ethicon Endo-Surgery, Cincinnati OH) and hemorrhoidopexy and prolapse (HEM)™ (Covidien, Inc.) staplers were used in respectively 106 and 78 cases. Surgery-related morbidity at 90 postoperative days (POD) based on the Clavien-Dindo procedure-related complication score and clinical outcome in terms of recurrence and reoperation rate at 12 postoperative months (POM) was collected. Results Three hundred and seventy-seven patients were randomized according to HD grade. In the DGHAL arm, the number of ligations and mucopexies was higher in the AMI group ( p  &lt; 0.0001); at 90 POD, the overall morbidity was similar between the two groups. In the CSH arm, donut sizes were similar; at 90 POD, the PPH group had a higher risk of postoperative grade 1 morbidity (anal urgency or incontinence) compared to the HEM group ( p  = 0.003). At 12 POM, no statistical difference was found between the two groups of each arm in terms of grade III recurrence or reoperation. Conclusion Postoperative morbidity and outcome at 1 year were similar regardless of the type of devices used. These findings suggest that device type has little impact on HD treatment results. Trial registration clinicaltrials.gov —Identifier NCT01240772</abstract><cop>Berlin/Heidelberg</cop><pub>Springer Berlin Heidelberg</pub><pmid>29808305</pmid><doi>10.1007/s00384-018-3093-8</doi><tpages>5</tpages><orcidid>https://orcid.org/0000-0003-1539-4797</orcidid></addata></record>
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identifier ISSN: 0179-1958
ispartof International journal of colorectal disease, 2018-10, Vol.33 (10), p.1479-1483
issn 0179-1958
1432-1262
1432-1262
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source MEDLINE; SpringerLink Journals
subjects Adult
Arteries - surgery
Comparative analysis
Digestive System Surgical Procedures - instrumentation
Digestive System Surgical Procedures - methods
Gastroenterology
Hemorrhoids
Hemorrhoids - surgery
Hepatology
Humans
Internal Medicine
Life Sciences
Ligation
Medical equipment
Medical innovations
Medicine
Medicine & Public Health
Morbidity
Original Article
Patients
Physiological apparatus
Proctology
Rectum
Surgery
Sutures
Treatment Outcome
Varicose veins
title A comparison of surgical devices for grade II and III hemorrhoidal disease. Results from the LigaLongo Trial comparing transanal Doppler-guided hemorrhoidal artery ligation with mucopexy and circular stapled hemorrhoidopexy
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