Randomized clinical trial of biodegradeable intraluminal sheath to prevent anastomotic leak after stapled colorectal anastomosis
Background Anastomotic leakage is a potential major complication after colorectal surgery. The C‐seal was developed to help reduce the clinical leakage rate. It is an intraluminal sheath that is stapled proximal to a colorectal anastomosis, covering it intraluminally and thus preventing intestinal l...
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| Veröffentlicht in: | British journal of surgery 2017-07, Vol.104 (8), p.1010-1019 |
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| creator | Bakker, I. S. Morks, A. N. ten Cate Hoedemaker, H. O. Burgerhof, J. G. M. Leuvenink, H. G. van Praagh, J. B. Ploeg, R. J. Havenga, K. Bakker, I. S. Morks, A. N. ten Cate Hoedemaker, H. O. Leuvenink, H. G. Ploeg, R. J. Havenga, K. van Etten, B. Lange, J. F. M. Hemmer, P. H. J. Burgerhof, J. G. M. Sonneveld, D. J. A. Tanis, P. J. Wegdam, J. A. Jonk, A. Lutke Holzik, M. F. Bosker, R. J. I. Lamme, B. Spillenaar Bilgen, E. J. Bremers, A. J. van der Mijle, H. C. Hoff, C. de Vries, D. P. Logeman, F. Sietses, C. Lesanka Versluijs‐Ossewaarde, F. N. Leijtens, J. W. Tobon Morales, R. E. Neijenhuis, P. A. Kloppenberg, F. W. Schasfoort, R. Bleeker, W. A. Hess, D. Rosman, C. Wit, F. Ton van Engelenburg, K. C. Pronk, A. Bonsing, B. A. Dekker, J. W. Consten, E. C. Patijn, G. A. Bogdan Rajcs, S. Csapó, Z. Bálint, A. Harsányi, L. István, G. Horisberger, K. Bader, F. Kutup, A. Mariette, C. Cebrián, F. |
| description | Background
Anastomotic leakage is a potential major complication after colorectal surgery. The C‐seal was developed to help reduce the clinical leakage rate. It is an intraluminal sheath that is stapled proximal to a colorectal anastomosis, covering it intraluminally and thus preventing intestinal leakage in case of anastomotic dehiscence. The C‐seal trial was initiated to evaluate the efficacy of the C‐seal in reducing anastomotic leakage in stapled colorectal anastomoses.
Methods
This RCT was performed in 41 hospitals in the Netherlands, Germany, France, Hungary and Spain. Patients undergoing elective surgery with a stapled colorectal anastomosis less than 15 cm from the anal verge were eligible. Included patients were randomized to the C‐seal and control groups, stratified for centre, anastomotic height and intention to create a defunctioning stoma. Primary outcome was anastomotic leakage requiring invasive treatment.
Results
Between December 2011 and December 2013, 402 patients were included in the trial, 202 in the C‐seal group and 200 in the control group. Anastomotic leakage was diagnosed in 31 patients (7·7 per cent), with a 10·4 per cent leak rate in the C‐seal group and 5·0 per cent in the control group (P = 0·060). Male sex showed a trend towards a higher leak rate (P = 0·055). Construction of a defunctioning stoma led to a lower leakage rate, although this was not significant (P = 0·095).
Conclusion
C‐seal application in stapled colorectal anastomoses does not reduce anastomotic leakage. Registration number: NTR3080 (http://www.trialregister.nl/trialreg/index.asp).
Not effective |
| doi_str_mv | 10.1002/bjs.10534 |
| format | Article |
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Anastomotic leakage is a potential major complication after colorectal surgery. The C‐seal was developed to help reduce the clinical leakage rate. It is an intraluminal sheath that is stapled proximal to a colorectal anastomosis, covering it intraluminally and thus preventing intestinal leakage in case of anastomotic dehiscence. The C‐seal trial was initiated to evaluate the efficacy of the C‐seal in reducing anastomotic leakage in stapled colorectal anastomoses.
Methods
This RCT was performed in 41 hospitals in the Netherlands, Germany, France, Hungary and Spain. Patients undergoing elective surgery with a stapled colorectal anastomosis less than 15 cm from the anal verge were eligible. Included patients were randomized to the C‐seal and control groups, stratified for centre, anastomotic height and intention to create a defunctioning stoma. Primary outcome was anastomotic leakage requiring invasive treatment.
Results
Between December 2011 and December 2013, 402 patients were included in the trial, 202 in the C‐seal group and 200 in the control group. Anastomotic leakage was diagnosed in 31 patients (7·7 per cent), with a 10·4 per cent leak rate in the C‐seal group and 5·0 per cent in the control group (P = 0·060). Male sex showed a trend towards a higher leak rate (P = 0·055). Construction of a defunctioning stoma led to a lower leakage rate, although this was not significant (P = 0·095).
Conclusion
C‐seal application in stapled colorectal anastomoses does not reduce anastomotic leakage. Registration number: NTR3080 (http://www.trialregister.nl/trialreg/index.asp).
Not effective</description><identifier>ISSN: 0007-1323</identifier><identifier>EISSN: 1365-2168</identifier><identifier>DOI: 10.1002/bjs.10534</identifier><identifier>PMID: 28488729</identifier><language>eng</language><publisher>Chichester, UK: John Wiley & Sons, Ltd</publisher><subject>Absorbable Implants ; Aged ; Anastomosis, Surgical - adverse effects ; Anastomotic Leak - prevention & control ; Clinical trials ; Colon - surgery ; Colorectal Neoplasms - surgery ; Diverticulum, Colon - surgery ; Female ; Humans ; Male ; Middle Aged ; Ostomy ; Prosthesis Design ; Rectum - surgery ; Surgical Stapling - adverse effects</subject><ispartof>British journal of surgery, 2017-07, Vol.104 (8), p.1010-1019</ispartof><rights>2017 BJS Society Ltd Published by John Wiley & Sons Ltd</rights><rights>2017 BJS Society Ltd Published by John Wiley & Sons Ltd.</rights><rights>Copyright © 2017 BJS Society Ltd. Published by John Wiley & Sons, Ltd.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c3194-c48a4a7eaa3ea222d4240b95208e48bd6e64c4d7d6bd75c80fcc2a0ae78142c53</citedby></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1002%2Fbjs.10534$$EPDF$$P50$$Gwiley$$H</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1002%2Fbjs.10534$$EHTML$$P50$$Gwiley$$H</linktohtml><link.rule.ids>314,776,780,1411,27901,27902,45550,45551</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/28488729$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Bakker, I. S.</creatorcontrib><creatorcontrib>Morks, A. N.</creatorcontrib><creatorcontrib>ten Cate Hoedemaker, H. O.</creatorcontrib><creatorcontrib>Burgerhof, J. G. M.</creatorcontrib><creatorcontrib>Leuvenink, H. G.</creatorcontrib><creatorcontrib>van Praagh, J. B.</creatorcontrib><creatorcontrib>Ploeg, R. J.</creatorcontrib><creatorcontrib>Havenga, K.</creatorcontrib><creatorcontrib>Bakker, I. S.</creatorcontrib><creatorcontrib>Morks, A. N.</creatorcontrib><creatorcontrib>ten Cate Hoedemaker, H. O.</creatorcontrib><creatorcontrib>Leuvenink, H. G.</creatorcontrib><creatorcontrib>Ploeg, R. J.</creatorcontrib><creatorcontrib>Havenga, K.</creatorcontrib><creatorcontrib>van Etten, B.</creatorcontrib><creatorcontrib>Lange, J. F. M.</creatorcontrib><creatorcontrib>Hemmer, P. H. J.</creatorcontrib><creatorcontrib>Burgerhof, J. G. M.</creatorcontrib><creatorcontrib>Sonneveld, D. J. A.</creatorcontrib><creatorcontrib>Tanis, P. J.</creatorcontrib><creatorcontrib>Wegdam, J. A.</creatorcontrib><creatorcontrib>Jonk, A.</creatorcontrib><creatorcontrib>Lutke Holzik, M. F.</creatorcontrib><creatorcontrib>Bosker, R. J. I.</creatorcontrib><creatorcontrib>Lamme, B.</creatorcontrib><creatorcontrib>Spillenaar Bilgen, E. J.</creatorcontrib><creatorcontrib>Bremers, A. J.</creatorcontrib><creatorcontrib>van der Mijle, H. C.</creatorcontrib><creatorcontrib>Hoff, C.</creatorcontrib><creatorcontrib>de Vries, D. P.</creatorcontrib><creatorcontrib>Logeman, F.</creatorcontrib><creatorcontrib>Sietses, C.</creatorcontrib><creatorcontrib>Lesanka Versluijs‐Ossewaarde, F. N.</creatorcontrib><creatorcontrib>Leijtens, J. W.</creatorcontrib><creatorcontrib>Tobon Morales, R. E.</creatorcontrib><creatorcontrib>Neijenhuis, P. A.</creatorcontrib><creatorcontrib>Kloppenberg, F. W.</creatorcontrib><creatorcontrib>Schasfoort, R.</creatorcontrib><creatorcontrib>Bleeker, W. A.</creatorcontrib><creatorcontrib>Hess, D.</creatorcontrib><creatorcontrib>Rosman, C.</creatorcontrib><creatorcontrib>Wit, F.</creatorcontrib><creatorcontrib>Ton van Engelenburg, K. C.</creatorcontrib><creatorcontrib>Pronk, A.</creatorcontrib><creatorcontrib>Bonsing, B. A.</creatorcontrib><creatorcontrib>Dekker, J. W.</creatorcontrib><creatorcontrib>Consten, E. C.</creatorcontrib><creatorcontrib>Patijn, G. A.</creatorcontrib><creatorcontrib>Bogdan Rajcs, S.</creatorcontrib><creatorcontrib>Csapó, Z.</creatorcontrib><creatorcontrib>Bálint, A.</creatorcontrib><creatorcontrib>Harsányi, L.</creatorcontrib><creatorcontrib>István, G.</creatorcontrib><creatorcontrib>Horisberger, K.</creatorcontrib><creatorcontrib>Bader, F.</creatorcontrib><creatorcontrib>Kutup, A.</creatorcontrib><creatorcontrib>Mariette, C.</creatorcontrib><creatorcontrib>Cebrián, F.</creatorcontrib><creatorcontrib>Collaborative C-seal Study Group</creatorcontrib><title>Randomized clinical trial of biodegradeable intraluminal sheath to prevent anastomotic leak after stapled colorectal anastomosis</title><title>British journal of surgery</title><addtitle>Br J Surg</addtitle><description>Background
Anastomotic leakage is a potential major complication after colorectal surgery. The C‐seal was developed to help reduce the clinical leakage rate. It is an intraluminal sheath that is stapled proximal to a colorectal anastomosis, covering it intraluminally and thus preventing intestinal leakage in case of anastomotic dehiscence. The C‐seal trial was initiated to evaluate the efficacy of the C‐seal in reducing anastomotic leakage in stapled colorectal anastomoses.
Methods
This RCT was performed in 41 hospitals in the Netherlands, Germany, France, Hungary and Spain. Patients undergoing elective surgery with a stapled colorectal anastomosis less than 15 cm from the anal verge were eligible. Included patients were randomized to the C‐seal and control groups, stratified for centre, anastomotic height and intention to create a defunctioning stoma. Primary outcome was anastomotic leakage requiring invasive treatment.
Results
Between December 2011 and December 2013, 402 patients were included in the trial, 202 in the C‐seal group and 200 in the control group. Anastomotic leakage was diagnosed in 31 patients (7·7 per cent), with a 10·4 per cent leak rate in the C‐seal group and 5·0 per cent in the control group (P = 0·060). Male sex showed a trend towards a higher leak rate (P = 0·055). Construction of a defunctioning stoma led to a lower leakage rate, although this was not significant (P = 0·095).
Conclusion
C‐seal application in stapled colorectal anastomoses does not reduce anastomotic leakage. Registration number: NTR3080 (http://www.trialregister.nl/trialreg/index.asp).
Not effective</description><subject>Absorbable Implants</subject><subject>Aged</subject><subject>Anastomosis, Surgical - adverse effects</subject><subject>Anastomotic Leak - prevention & control</subject><subject>Clinical trials</subject><subject>Colon - surgery</subject><subject>Colorectal Neoplasms - surgery</subject><subject>Diverticulum, Colon - surgery</subject><subject>Female</subject><subject>Humans</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Ostomy</subject><subject>Prosthesis Design</subject><subject>Rectum - surgery</subject><subject>Surgical Stapling - adverse effects</subject><issn>0007-1323</issn><issn>1365-2168</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2017</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNpdkUtv1TAQhS0EoreFBX8AWWLDJnT8SOIsoSoUVAmJxzqa2HOpL058sR1QWfHT8e2DBZuZI803R5o5jD0T8EoAyNNpl6tolX7ANkJ1bSNFZx6yDQD0jVBSHbHjnHcAQkErH7MjabQxvRw27M8nXFyc_W9y3Aa_eIuBl-RrjVs--ejoW0JHOAXifikJwzr7pY7zFWG54iXyfaKftBSOC-YS51i85YHwO8dtocRzwX042McQE9lSd-_J7PMT9miLIdPTu37Cvr49_3J20Vx-fPf-7PVlY5UYdGO1QY09ISpCKaXTUsM0tBIMaTO5jjpttetdN7m-tQa21koEpN4ILW2rTtjLW999ij9WymWcfbYUAi4U1zwKMwz1hxIO6Iv_0F1cU725UgOY3kjRQqWe31HrNJMb98nPmK7H-99W4PQW-OUDXf-bCxgPoY01tPEmtPHNh883Qv0F-0KLqA</recordid><startdate>201707</startdate><enddate>201707</enddate><creator>Bakker, I. S.</creator><creator>Morks, A. N.</creator><creator>ten Cate Hoedemaker, H. O.</creator><creator>Burgerhof, J. G. M.</creator><creator>Leuvenink, H. G.</creator><creator>van Praagh, J. B.</creator><creator>Ploeg, R. J.</creator><creator>Havenga, K.</creator><creator>Bakker, I. S.</creator><creator>Morks, A. N.</creator><creator>ten Cate Hoedemaker, H. O.</creator><creator>Leuvenink, H. G.</creator><creator>Ploeg, R. J.</creator><creator>Havenga, K.</creator><creator>van Etten, B.</creator><creator>Lange, J. F. M.</creator><creator>Hemmer, P. H. J.</creator><creator>Burgerhof, J. G. M.</creator><creator>Sonneveld, D. J. A.</creator><creator>Tanis, P. J.</creator><creator>Wegdam, J. A.</creator><creator>Jonk, A.</creator><creator>Lutke Holzik, M. F.</creator><creator>Bosker, R. J. I.</creator><creator>Lamme, B.</creator><creator>Spillenaar Bilgen, E. J.</creator><creator>Bremers, A. J.</creator><creator>van der Mijle, H. C.</creator><creator>Hoff, C.</creator><creator>de Vries, D. P.</creator><creator>Logeman, F.</creator><creator>Sietses, C.</creator><creator>Lesanka Versluijs‐Ossewaarde, F. N.</creator><creator>Leijtens, J. W.</creator><creator>Tobon Morales, R. E.</creator><creator>Neijenhuis, P. A.</creator><creator>Kloppenberg, F. W.</creator><creator>Schasfoort, R.</creator><creator>Bleeker, W. A.</creator><creator>Hess, D.</creator><creator>Rosman, C.</creator><creator>Wit, F.</creator><creator>Ton van Engelenburg, K. C.</creator><creator>Pronk, A.</creator><creator>Bonsing, B. A.</creator><creator>Dekker, J. W.</creator><creator>Consten, E. C.</creator><creator>Patijn, G. A.</creator><creator>Bogdan Rajcs, S.</creator><creator>Csapó, Z.</creator><creator>Bálint, A.</creator><creator>Harsányi, L.</creator><creator>István, G.</creator><creator>Horisberger, K.</creator><creator>Bader, F.</creator><creator>Kutup, A.</creator><creator>Mariette, C.</creator><creator>Cebrián, F.</creator><general>John Wiley & Sons, Ltd</general><general>Oxford University Press</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>K9.</scope><scope>7X8</scope></search><sort><creationdate>201707</creationdate><title>Randomized clinical trial of biodegradeable intraluminal sheath to prevent anastomotic leak after stapled colorectal anastomosis</title><author>Bakker, I. S. ; Morks, A. N. ; ten Cate Hoedemaker, H. O. ; Burgerhof, J. G. M. ; Leuvenink, H. G. ; van Praagh, J. B. ; Ploeg, R. J. ; Havenga, K. ; Bakker, I. S. ; Morks, A. N. ; ten Cate Hoedemaker, H. O. ; Leuvenink, H. G. ; Ploeg, R. J. ; Havenga, K. ; van Etten, B. ; Lange, J. F. M. ; Hemmer, P. H. J. ; Burgerhof, J. G. M. ; Sonneveld, D. J. A. ; Tanis, P. J. ; Wegdam, J. A. ; Jonk, A. ; Lutke Holzik, M. F. ; Bosker, R. J. I. ; Lamme, B. ; Spillenaar Bilgen, E. J. ; Bremers, A. J. ; van der Mijle, H. C. ; Hoff, C. ; de Vries, D. P. ; Logeman, F. ; Sietses, C. ; Lesanka Versluijs‐Ossewaarde, F. N. ; Leijtens, J. W. ; Tobon Morales, R. E. ; Neijenhuis, P. A. ; Kloppenberg, F. W. ; Schasfoort, R. ; Bleeker, W. A. ; Hess, D. ; Rosman, C. ; Wit, F. ; Ton van Engelenburg, K. C. ; Pronk, A. ; Bonsing, B. A. ; Dekker, J. W. ; Consten, E. C. ; Patijn, G. A. ; Bogdan Rajcs, S. ; Csapó, Z. ; Bálint, A. ; Harsányi, L. ; István, G. ; Horisberger, K. ; Bader, F. ; Kutup, A. ; Mariette, C. ; Cebrián, F.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c3194-c48a4a7eaa3ea222d4240b95208e48bd6e64c4d7d6bd75c80fcc2a0ae78142c53</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2017</creationdate><topic>Absorbable Implants</topic><topic>Aged</topic><topic>Anastomosis, Surgical - adverse effects</topic><topic>Anastomotic Leak - prevention & control</topic><topic>Clinical trials</topic><topic>Colon - surgery</topic><topic>Colorectal Neoplasms - surgery</topic><topic>Diverticulum, Colon - surgery</topic><topic>Female</topic><topic>Humans</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Ostomy</topic><topic>Prosthesis Design</topic><topic>Rectum - surgery</topic><topic>Surgical Stapling - adverse effects</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Bakker, I. S.</creatorcontrib><creatorcontrib>Morks, A. N.</creatorcontrib><creatorcontrib>ten Cate Hoedemaker, H. O.</creatorcontrib><creatorcontrib>Burgerhof, J. G. M.</creatorcontrib><creatorcontrib>Leuvenink, H. G.</creatorcontrib><creatorcontrib>van Praagh, J. B.</creatorcontrib><creatorcontrib>Ploeg, R. J.</creatorcontrib><creatorcontrib>Havenga, K.</creatorcontrib><creatorcontrib>Bakker, I. S.</creatorcontrib><creatorcontrib>Morks, A. N.</creatorcontrib><creatorcontrib>ten Cate Hoedemaker, H. O.</creatorcontrib><creatorcontrib>Leuvenink, H. G.</creatorcontrib><creatorcontrib>Ploeg, R. J.</creatorcontrib><creatorcontrib>Havenga, K.</creatorcontrib><creatorcontrib>van Etten, B.</creatorcontrib><creatorcontrib>Lange, J. F. M.</creatorcontrib><creatorcontrib>Hemmer, P. H. J.</creatorcontrib><creatorcontrib>Burgerhof, J. G. M.</creatorcontrib><creatorcontrib>Sonneveld, D. J. A.</creatorcontrib><creatorcontrib>Tanis, P. J.</creatorcontrib><creatorcontrib>Wegdam, J. A.</creatorcontrib><creatorcontrib>Jonk, A.</creatorcontrib><creatorcontrib>Lutke Holzik, M. F.</creatorcontrib><creatorcontrib>Bosker, R. J. I.</creatorcontrib><creatorcontrib>Lamme, B.</creatorcontrib><creatorcontrib>Spillenaar Bilgen, E. J.</creatorcontrib><creatorcontrib>Bremers, A. J.</creatorcontrib><creatorcontrib>van der Mijle, H. C.</creatorcontrib><creatorcontrib>Hoff, C.</creatorcontrib><creatorcontrib>de Vries, D. P.</creatorcontrib><creatorcontrib>Logeman, F.</creatorcontrib><creatorcontrib>Sietses, C.</creatorcontrib><creatorcontrib>Lesanka Versluijs‐Ossewaarde, F. N.</creatorcontrib><creatorcontrib>Leijtens, J. W.</creatorcontrib><creatorcontrib>Tobon Morales, R. E.</creatorcontrib><creatorcontrib>Neijenhuis, P. A.</creatorcontrib><creatorcontrib>Kloppenberg, F. W.</creatorcontrib><creatorcontrib>Schasfoort, R.</creatorcontrib><creatorcontrib>Bleeker, W. 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A.</creatorcontrib><creatorcontrib>Bogdan Rajcs, S.</creatorcontrib><creatorcontrib>Csapó, Z.</creatorcontrib><creatorcontrib>Bálint, A.</creatorcontrib><creatorcontrib>Harsányi, L.</creatorcontrib><creatorcontrib>István, G.</creatorcontrib><creatorcontrib>Horisberger, K.</creatorcontrib><creatorcontrib>Bader, F.</creatorcontrib><creatorcontrib>Kutup, A.</creatorcontrib><creatorcontrib>Mariette, C.</creatorcontrib><creatorcontrib>Cebrián, F.</creatorcontrib><creatorcontrib>Collaborative C-seal Study Group</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>MEDLINE - Academic</collection><jtitle>British journal of surgery</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Bakker, I. S.</au><au>Morks, A. N.</au><au>ten Cate Hoedemaker, H. O.</au><au>Burgerhof, J. G. M.</au><au>Leuvenink, H. G.</au><au>van Praagh, J. B.</au><au>Ploeg, R. J.</au><au>Havenga, K.</au><au>Bakker, I. S.</au><au>Morks, A. N.</au><au>ten Cate Hoedemaker, H. O.</au><au>Leuvenink, H. G.</au><au>Ploeg, R. J.</au><au>Havenga, K.</au><au>van Etten, B.</au><au>Lange, J. F. M.</au><au>Hemmer, P. H. J.</au><au>Burgerhof, J. G. M.</au><au>Sonneveld, D. J. A.</au><au>Tanis, P. J.</au><au>Wegdam, J. A.</au><au>Jonk, A.</au><au>Lutke Holzik, M. F.</au><au>Bosker, R. J. I.</au><au>Lamme, B.</au><au>Spillenaar Bilgen, E. J.</au><au>Bremers, A. J.</au><au>van der Mijle, H. C.</au><au>Hoff, C.</au><au>de Vries, D. P.</au><au>Logeman, F.</au><au>Sietses, C.</au><au>Lesanka Versluijs‐Ossewaarde, F. N.</au><au>Leijtens, J. W.</au><au>Tobon Morales, R. E.</au><au>Neijenhuis, P. A.</au><au>Kloppenberg, F. W.</au><au>Schasfoort, R.</au><au>Bleeker, W. A.</au><au>Hess, D.</au><au>Rosman, C.</au><au>Wit, F.</au><au>Ton van Engelenburg, K. C.</au><au>Pronk, A.</au><au>Bonsing, B. A.</au><au>Dekker, J. W.</au><au>Consten, E. C.</au><au>Patijn, G. A.</au><au>Bogdan Rajcs, S.</au><au>Csapó, Z.</au><au>Bálint, A.</au><au>Harsányi, L.</au><au>István, G.</au><au>Horisberger, K.</au><au>Bader, F.</au><au>Kutup, A.</au><au>Mariette, C.</au><au>Cebrián, F.</au><aucorp>Collaborative C-seal Study Group</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Randomized clinical trial of biodegradeable intraluminal sheath to prevent anastomotic leak after stapled colorectal anastomosis</atitle><jtitle>British journal of surgery</jtitle><addtitle>Br J Surg</addtitle><date>2017-07</date><risdate>2017</risdate><volume>104</volume><issue>8</issue><spage>1010</spage><epage>1019</epage><pages>1010-1019</pages><issn>0007-1323</issn><eissn>1365-2168</eissn><abstract>Background
Anastomotic leakage is a potential major complication after colorectal surgery. The C‐seal was developed to help reduce the clinical leakage rate. It is an intraluminal sheath that is stapled proximal to a colorectal anastomosis, covering it intraluminally and thus preventing intestinal leakage in case of anastomotic dehiscence. The C‐seal trial was initiated to evaluate the efficacy of the C‐seal in reducing anastomotic leakage in stapled colorectal anastomoses.
Methods
This RCT was performed in 41 hospitals in the Netherlands, Germany, France, Hungary and Spain. Patients undergoing elective surgery with a stapled colorectal anastomosis less than 15 cm from the anal verge were eligible. Included patients were randomized to the C‐seal and control groups, stratified for centre, anastomotic height and intention to create a defunctioning stoma. Primary outcome was anastomotic leakage requiring invasive treatment.
Results
Between December 2011 and December 2013, 402 patients were included in the trial, 202 in the C‐seal group and 200 in the control group. Anastomotic leakage was diagnosed in 31 patients (7·7 per cent), with a 10·4 per cent leak rate in the C‐seal group and 5·0 per cent in the control group (P = 0·060). Male sex showed a trend towards a higher leak rate (P = 0·055). Construction of a defunctioning stoma led to a lower leakage rate, although this was not significant (P = 0·095).
Conclusion
C‐seal application in stapled colorectal anastomoses does not reduce anastomotic leakage. Registration number: NTR3080 (http://www.trialregister.nl/trialreg/index.asp).
Not effective</abstract><cop>Chichester, UK</cop><pub>John Wiley & Sons, Ltd</pub><pmid>28488729</pmid><doi>10.1002/bjs.10534</doi><tpages>10</tpages></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 0007-1323 |
| ispartof | British journal of surgery, 2017-07, Vol.104 (8), p.1010-1019 |
| issn | 0007-1323 1365-2168 |
| language | eng |
| recordid | cdi_proquest_miscellaneous_1899105205 |
| source | Oxford University Press Journals All Titles (1996-Current); MEDLINE; Wiley Online Library Journals Frontfile Complete |
| subjects | Absorbable Implants Aged Anastomosis, Surgical - adverse effects Anastomotic Leak - prevention & control Clinical trials Colon - surgery Colorectal Neoplasms - surgery Diverticulum, Colon - surgery Female Humans Male Middle Aged Ostomy Prosthesis Design Rectum - surgery Surgical Stapling - adverse effects |
| title | Randomized clinical trial of biodegradeable intraluminal sheath to prevent anastomotic leak after stapled colorectal anastomosis |
| url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2025-02-05T06%3A28%3A26IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-proquest_pubme&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Randomized%20clinical%20trial%20of%20biodegradeable%20intraluminal%20sheath%20to%20prevent%20anastomotic%20leak%20after%20stapled%20colorectal%20anastomosis&rft.jtitle=British%20journal%20of%20surgery&rft.au=Bakker,%20I.%20S.&rft.aucorp=Collaborative%20C-seal%20Study%20Group&rft.date=2017-07&rft.volume=104&rft.issue=8&rft.spage=1010&rft.epage=1019&rft.pages=1010-1019&rft.issn=0007-1323&rft.eissn=1365-2168&rft_id=info:doi/10.1002/bjs.10534&rft_dat=%3Cproquest_pubme%3E1908782150%3C/proquest_pubme%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_pqid=1908782150&rft_id=info:pmid/28488729&rfr_iscdi=true |