Seton or glue for trans-sphincteric anal fistulae: a prospective randomized crossover clinical trial
Objective Fibrin glue treatment of anal fistulae has been proposed to minimize the risk of faecal incontinence but its acceptance by coloproctologists is still poor because the published data is controversial. Therefore, we carried out a prospective randomized crossover trial comparing treatment wi...
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| Veröffentlicht in: | Colorectal disease 2011-01, Vol.13 (1), p.82-86 |
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| creator | Altomare, D. F. Greco, V. J. Tricomi, N. Arcanà, F. Mancini, S. Rinaldi, M. Pulvirenti d'Urso, A. La Torre, F. |
| description | Objective Fibrin glue treatment of anal fistulae has been proposed to minimize the risk of faecal incontinence but its acceptance by coloproctologists is still poor because the published data is controversial. Therefore, we carried out a prospective randomized crossover trial comparing treatment with a commercial fibrin glue to classical seton treatment, with healing rate, hospital stay, healing time, faecal incontinence and postoperative pain as study outcomes.
Method Sixty‐four homogeneous patients with trans‐sphincteric anal fistulae referred to seven colorectal units were randomized to undergo fibrin glue (39 patients) or seton (25 patients) treatment. Patients failing to heal after treatment with fibrin glue were re‐randomized to undergo a second injection with glue or seton treatment.
Results Sixty‐two of the 64 patients completed the minimum 1‐year follow‐up period. Twenty‐one of 24 patients healed in the seton group compared with 15/38 in the fibrin glue group (P = 0.0007). The 23 failures after glue treatment were re‐randomized to have a second glue injection (eight patients) or a seton treatment (15 patients). Four of the eight (50%) patients treated with a second injection of glue, and nine out of the 15 (60%) patients in the seton group, healed. Patients treated with fibrin glue reported less postoperative pain and had a shorter hospital stay than patients treated with a seton; furthermore, faecal continence and anal manometry significantly worsened after seton treatment.
Conclusion Seton treatment has a significantly higher probability of success compared with fibrin glue treatment but poses a higher risk of faecal incontinence. Fibrin glue could be considered as a first line of treatment for patients at risk of faecal incontinence or other comorbidities. |
| doi_str_mv | 10.1111/j.1463-1318.2009.02056.x |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_miscellaneous_821199403</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>821199403</sourcerecordid><originalsourceid>FETCH-LOGICAL-c4076-5307c80e8d023cd058532894269fa8925149dac886caa4c4f9ba845977b289573</originalsourceid><addsrcrecordid>eNqNkEtP3DAUhS1UxKv8BeQdqwQ_ktjuAqkaOhSEQFWnqtSN5XFuwFNPMtgJHfrrcWZGdFtvfGWfc-7RhxCmJKfpXCxyWlQ8o5zKnBGicsJIWeXrPXT0_vFhM7NMKkoO0XGMC0JoJag8QIdUSc6k4Eeo_g591-Iu4Ec_AG7S0AfTxiyunlxrewjOYtMajxsX-8Eb-IQNXoUursD27gVwUtfd0v2FGtv0HLsXCNh61zqbXH1wxn9E-43xEU539wn6Mf0ym3zN7h6ubyaf7zJbEFFlJSfCSgKyJozbmpSyTC1VwSrVGKlYSQtVGytlZY0pbNGouZFFqYSYJ1kp-Ak63-amfs8DxF4vXbTgvWmhG6KWjFKlCsKTUm6Vm8oBGr0KbmnCq6ZEj4j1Qo8k9UhSj4j1BrFeJ-vZbskwX0L9z7hjmgSXW8Ef5-H1v4P15OHqZhxTQLYNSMRh_R5gwm9dCS5K_fP-Ws--3U5-zTjTU_4Gch2Z9w</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>821199403</pqid></control><display><type>article</type><title>Seton or glue for trans-sphincteric anal fistulae: a prospective randomized crossover clinical trial</title><source>MEDLINE</source><source>Wiley Online Library Journals Frontfile Complete</source><creator>Altomare, D. F. ; Greco, V. J. ; Tricomi, N. ; Arcanà, F. ; Mancini, S. ; Rinaldi, M. ; Pulvirenti d'Urso, A. ; La Torre, F.</creator><creatorcontrib>Altomare, D. F. ; Greco, V. J. ; Tricomi, N. ; Arcanà, F. ; Mancini, S. ; Rinaldi, M. ; Pulvirenti d'Urso, A. ; La Torre, F.</creatorcontrib><description>Objective Fibrin glue treatment of anal fistulae has been proposed to minimize the risk of faecal incontinence but its acceptance by coloproctologists is still poor because the published data is controversial. Therefore, we carried out a prospective randomized crossover trial comparing treatment with a commercial fibrin glue to classical seton treatment, with healing rate, hospital stay, healing time, faecal incontinence and postoperative pain as study outcomes.
Method Sixty‐four homogeneous patients with trans‐sphincteric anal fistulae referred to seven colorectal units were randomized to undergo fibrin glue (39 patients) or seton (25 patients) treatment. Patients failing to heal after treatment with fibrin glue were re‐randomized to undergo a second injection with glue or seton treatment.
Results Sixty‐two of the 64 patients completed the minimum 1‐year follow‐up period. Twenty‐one of 24 patients healed in the seton group compared with 15/38 in the fibrin glue group (P = 0.0007). The 23 failures after glue treatment were re‐randomized to have a second glue injection (eight patients) or a seton treatment (15 patients). Four of the eight (50%) patients treated with a second injection of glue, and nine out of the 15 (60%) patients in the seton group, healed. Patients treated with fibrin glue reported less postoperative pain and had a shorter hospital stay than patients treated with a seton; furthermore, faecal continence and anal manometry significantly worsened after seton treatment.
Conclusion Seton treatment has a significantly higher probability of success compared with fibrin glue treatment but poses a higher risk of faecal incontinence. Fibrin glue could be considered as a first line of treatment for patients at risk of faecal incontinence or other comorbidities.</description><identifier>ISSN: 1462-8910</identifier><identifier>EISSN: 1463-1318</identifier><identifier>DOI: 10.1111/j.1463-1318.2009.02056.x</identifier><identifier>PMID: 19832873</identifier><language>eng</language><publisher>Oxford, UK: Blackwell Publishing Ltd</publisher><subject>Anal Canal - surgery ; Chi-Square Distribution ; Cross-Over Studies ; Curettage ; Female ; Fibrin glue ; Fibrin Tissue Adhesive - therapeutic use ; Humans ; incontinence ; Length of Stay - statistics & numerical data ; Male ; Middle Aged ; Pain Measurement ; prospective randomized trial ; Prospective Studies ; Rectal Fistula - surgery ; Rectal Fistula - therapy ; seton ; Statistics, Nonparametric ; trans-sphincteric anal fistulae ; Treatment Outcome ; Wound Healing</subject><ispartof>Colorectal disease, 2011-01, Vol.13 (1), p.82-86</ispartof><rights>2010 The Authors. Colorectal Disease © 2010 The Association of Coloproctology of Great Britain and Ireland</rights><rights>2010 The Authors. Colorectal Disease © 2010 The Association of Coloproctology of Great Britain and Ireland.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c4076-5307c80e8d023cd058532894269fa8925149dac886caa4c4f9ba845977b289573</citedby><cites>FETCH-LOGICAL-c4076-5307c80e8d023cd058532894269fa8925149dac886caa4c4f9ba845977b289573</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1111%2Fj.1463-1318.2009.02056.x$$EPDF$$P50$$Gwiley$$H</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1111%2Fj.1463-1318.2009.02056.x$$EHTML$$P50$$Gwiley$$H</linktohtml><link.rule.ids>314,776,780,1411,27903,27904,45553,45554</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/19832873$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Altomare, D. F.</creatorcontrib><creatorcontrib>Greco, V. J.</creatorcontrib><creatorcontrib>Tricomi, N.</creatorcontrib><creatorcontrib>Arcanà, F.</creatorcontrib><creatorcontrib>Mancini, S.</creatorcontrib><creatorcontrib>Rinaldi, M.</creatorcontrib><creatorcontrib>Pulvirenti d'Urso, A.</creatorcontrib><creatorcontrib>La Torre, F.</creatorcontrib><title>Seton or glue for trans-sphincteric anal fistulae: a prospective randomized crossover clinical trial</title><title>Colorectal disease</title><addtitle>Colorectal Dis</addtitle><description>Objective Fibrin glue treatment of anal fistulae has been proposed to minimize the risk of faecal incontinence but its acceptance by coloproctologists is still poor because the published data is controversial. Therefore, we carried out a prospective randomized crossover trial comparing treatment with a commercial fibrin glue to classical seton treatment, with healing rate, hospital stay, healing time, faecal incontinence and postoperative pain as study outcomes.
Method Sixty‐four homogeneous patients with trans‐sphincteric anal fistulae referred to seven colorectal units were randomized to undergo fibrin glue (39 patients) or seton (25 patients) treatment. Patients failing to heal after treatment with fibrin glue were re‐randomized to undergo a second injection with glue or seton treatment.
Results Sixty‐two of the 64 patients completed the minimum 1‐year follow‐up period. Twenty‐one of 24 patients healed in the seton group compared with 15/38 in the fibrin glue group (P = 0.0007). The 23 failures after glue treatment were re‐randomized to have a second glue injection (eight patients) or a seton treatment (15 patients). Four of the eight (50%) patients treated with a second injection of glue, and nine out of the 15 (60%) patients in the seton group, healed. Patients treated with fibrin glue reported less postoperative pain and had a shorter hospital stay than patients treated with a seton; furthermore, faecal continence and anal manometry significantly worsened after seton treatment.
Conclusion Seton treatment has a significantly higher probability of success compared with fibrin glue treatment but poses a higher risk of faecal incontinence. Fibrin glue could be considered as a first line of treatment for patients at risk of faecal incontinence or other comorbidities.</description><subject>Anal Canal - surgery</subject><subject>Chi-Square Distribution</subject><subject>Cross-Over Studies</subject><subject>Curettage</subject><subject>Female</subject><subject>Fibrin glue</subject><subject>Fibrin Tissue Adhesive - therapeutic use</subject><subject>Humans</subject><subject>incontinence</subject><subject>Length of Stay - statistics & numerical data</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Pain Measurement</subject><subject>prospective randomized trial</subject><subject>Prospective Studies</subject><subject>Rectal Fistula - surgery</subject><subject>Rectal Fistula - therapy</subject><subject>seton</subject><subject>Statistics, Nonparametric</subject><subject>trans-sphincteric anal fistulae</subject><subject>Treatment Outcome</subject><subject>Wound Healing</subject><issn>1462-8910</issn><issn>1463-1318</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2011</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqNkEtP3DAUhS1UxKv8BeQdqwQ_ktjuAqkaOhSEQFWnqtSN5XFuwFNPMtgJHfrrcWZGdFtvfGWfc-7RhxCmJKfpXCxyWlQ8o5zKnBGicsJIWeXrPXT0_vFhM7NMKkoO0XGMC0JoJag8QIdUSc6k4Eeo_g591-Iu4Ec_AG7S0AfTxiyunlxrewjOYtMajxsX-8Eb-IQNXoUursD27gVwUtfd0v2FGtv0HLsXCNh61zqbXH1wxn9E-43xEU539wn6Mf0ym3zN7h6ubyaf7zJbEFFlJSfCSgKyJozbmpSyTC1VwSrVGKlYSQtVGytlZY0pbNGouZFFqYSYJ1kp-Ak63-amfs8DxF4vXbTgvWmhG6KWjFKlCsKTUm6Vm8oBGr0KbmnCq6ZEj4j1Qo8k9UhSj4j1BrFeJ-vZbskwX0L9z7hjmgSXW8Ef5-H1v4P15OHqZhxTQLYNSMRh_R5gwm9dCS5K_fP-Ws--3U5-zTjTU_4Gch2Z9w</recordid><startdate>201101</startdate><enddate>201101</enddate><creator>Altomare, D. F.</creator><creator>Greco, V. J.</creator><creator>Tricomi, N.</creator><creator>Arcanà, F.</creator><creator>Mancini, S.</creator><creator>Rinaldi, M.</creator><creator>Pulvirenti d'Urso, A.</creator><creator>La Torre, F.</creator><general>Blackwell Publishing Ltd</general><scope>BSCLL</scope><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>7X8</scope></search><sort><creationdate>201101</creationdate><title>Seton or glue for trans-sphincteric anal fistulae: a prospective randomized crossover clinical trial</title><author>Altomare, D. F. ; Greco, V. J. ; Tricomi, N. ; Arcanà, F. ; Mancini, S. ; Rinaldi, M. ; Pulvirenti d'Urso, A. ; La Torre, F.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c4076-5307c80e8d023cd058532894269fa8925149dac886caa4c4f9ba845977b289573</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2011</creationdate><topic>Anal Canal - surgery</topic><topic>Chi-Square Distribution</topic><topic>Cross-Over Studies</topic><topic>Curettage</topic><topic>Female</topic><topic>Fibrin glue</topic><topic>Fibrin Tissue Adhesive - therapeutic use</topic><topic>Humans</topic><topic>incontinence</topic><topic>Length of Stay - statistics & numerical data</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Pain Measurement</topic><topic>prospective randomized trial</topic><topic>Prospective Studies</topic><topic>Rectal Fistula - surgery</topic><topic>Rectal Fistula - therapy</topic><topic>seton</topic><topic>Statistics, Nonparametric</topic><topic>trans-sphincteric anal fistulae</topic><topic>Treatment Outcome</topic><topic>Wound Healing</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Altomare, D. F.</creatorcontrib><creatorcontrib>Greco, V. J.</creatorcontrib><creatorcontrib>Tricomi, N.</creatorcontrib><creatorcontrib>Arcanà, F.</creatorcontrib><creatorcontrib>Mancini, S.</creatorcontrib><creatorcontrib>Rinaldi, M.</creatorcontrib><creatorcontrib>Pulvirenti d'Urso, A.</creatorcontrib><creatorcontrib>La Torre, F.</creatorcontrib><collection>Istex</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>Colorectal disease</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Altomare, D. F.</au><au>Greco, V. J.</au><au>Tricomi, N.</au><au>Arcanà, F.</au><au>Mancini, S.</au><au>Rinaldi, M.</au><au>Pulvirenti d'Urso, A.</au><au>La Torre, F.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Seton or glue for trans-sphincteric anal fistulae: a prospective randomized crossover clinical trial</atitle><jtitle>Colorectal disease</jtitle><addtitle>Colorectal Dis</addtitle><date>2011-01</date><risdate>2011</risdate><volume>13</volume><issue>1</issue><spage>82</spage><epage>86</epage><pages>82-86</pages><issn>1462-8910</issn><eissn>1463-1318</eissn><abstract>Objective Fibrin glue treatment of anal fistulae has been proposed to minimize the risk of faecal incontinence but its acceptance by coloproctologists is still poor because the published data is controversial. Therefore, we carried out a prospective randomized crossover trial comparing treatment with a commercial fibrin glue to classical seton treatment, with healing rate, hospital stay, healing time, faecal incontinence and postoperative pain as study outcomes.
Method Sixty‐four homogeneous patients with trans‐sphincteric anal fistulae referred to seven colorectal units were randomized to undergo fibrin glue (39 patients) or seton (25 patients) treatment. Patients failing to heal after treatment with fibrin glue were re‐randomized to undergo a second injection with glue or seton treatment.
Results Sixty‐two of the 64 patients completed the minimum 1‐year follow‐up period. Twenty‐one of 24 patients healed in the seton group compared with 15/38 in the fibrin glue group (P = 0.0007). The 23 failures after glue treatment were re‐randomized to have a second glue injection (eight patients) or a seton treatment (15 patients). Four of the eight (50%) patients treated with a second injection of glue, and nine out of the 15 (60%) patients in the seton group, healed. Patients treated with fibrin glue reported less postoperative pain and had a shorter hospital stay than patients treated with a seton; furthermore, faecal continence and anal manometry significantly worsened after seton treatment.
Conclusion Seton treatment has a significantly higher probability of success compared with fibrin glue treatment but poses a higher risk of faecal incontinence. Fibrin glue could be considered as a first line of treatment for patients at risk of faecal incontinence or other comorbidities.</abstract><cop>Oxford, UK</cop><pub>Blackwell Publishing Ltd</pub><pmid>19832873</pmid><doi>10.1111/j.1463-1318.2009.02056.x</doi><tpages>5</tpages></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 1462-8910 |
| ispartof | Colorectal disease, 2011-01, Vol.13 (1), p.82-86 |
| issn | 1462-8910 1463-1318 |
| language | eng |
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| source | MEDLINE; Wiley Online Library Journals Frontfile Complete |
| subjects | Anal Canal - surgery Chi-Square Distribution Cross-Over Studies Curettage Female Fibrin glue Fibrin Tissue Adhesive - therapeutic use Humans incontinence Length of Stay - statistics & numerical data Male Middle Aged Pain Measurement prospective randomized trial Prospective Studies Rectal Fistula - surgery Rectal Fistula - therapy seton Statistics, Nonparametric trans-sphincteric anal fistulae Treatment Outcome Wound Healing |
| title | Seton or glue for trans-sphincteric anal fistulae: a prospective randomized crossover clinical trial |
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