Safety and effectiveness of the Colovac anastomosis protection device compared with diverting ileostomy after low anterior resection: protocol for an international, multicentre, prospective, non-randomised comparative study (SAFE-3).
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| Title: | Safety and effectiveness of the Colovac anastomosis protection device compared with diverting ileostomy after low anterior resection: protocol for an international, multicentre, prospective, non-randomised comparative study (SAFE-3). |
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| Authors: | Pastier C; Department of Digestive Surgery, Sorbonne University, AP-HP, Hôpital Saint Antoine, Paris, France.; Gut, Liver & Microbiome Research (GLIMMER) FHU, Paris, France., Sylla P; Department of Surgery, Icahn School of Medicine at Mount Sinai, New york, New York, USA., Lee SW; Division of Colon and Rectal Surgery, University of Southern California, Los Angeles, California, USA., Spinelli A; Department of Biomedical Sciences, Humanitas University, Milan, Italy.; IRCCS Humanitas Research Hospital, Rozzano, Milan, Italy., Komen N; Department of Abdominal Surgery, Antwerp University Hospital, Edegem, Belgium.; Antwerp RESURG Group, Antwerp Surgical Training, Anatomy and Research Centre (ASTARC), Faculty of Medicine and Health Sciences, University of Antwerp, Wilrijk, Belgium., Marks J; Lankenau Medical Center, Main Line Health, Wynnewood, Pennsylvania, USA., Martz J; Division of Colon and Rectal Surgery, Lenox Hill Hospital, New York, New York, USA., Rhee R; Department of Surgery, Maimonides Medical Center, Brooklyn, New York, USA., Maykel J; Department of Surgery, UMass Memorial Medical Center, Worcester, Massachusetts, USA., Marcet J; Division of Colon and Rectal Surgery, University of South Florida, Tampa, Florida, USA., Denost Q; Department of General and Digestive Surgery, Bordeaux Colorectal Institute, Bordeaux, France., Zaghiyan K; Department of Surgery, Cedars-Sinai Medical Center, Los Angeles, California, USA., Davids JS; Department of Surgery, Boston University Chobanian & Avedisian School of Medicine, Boston Medical Center, Boston, Massachusetts, USA., Paluvoi N; Division of Colon and Rectal Surgery, Department of Surgery, University of Miami, Miller School of Medicine, Coral Gables, Florida, USA., Hiller D; Novant Health Colon & Rectal Clinic, Clemmons, North Carolina, USA., McLemore EC; Department of Clinical Science, Kaiser Permanente Bernard J. Tyson School of Medicine, Richmond, California, USA.; Colon and Rectal Surgery Research Chair, LAMC General Surgery Residency, Kaiser Permanente Los Angeles Medical Center (LAMC), Los Angeles, California, USA., Maggiori L; Department of General-Endocrine and Digestive Surgery, Saint Louis Hospital, Paris, France., D'hoore A; Department of Abdominal Surgery, University Hospitals Leuven, Leuven, Belgium., Jafari MD; New York-Presbyterian-Weill Cornell, New York, New York, USA., Poylin V; Department of Surgery, Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA., Buzas CJ; Department of General and Colorectal Surgery, Geisinger Medical Center, Danville, Pennsylvania, USA., Tuech JJ; Department of Digestive Surgery, Rouen University Hospital, Rouen, France., Lefèvre JH; Department of Digestive Surgery, Sorbonne University, AP-HP, Hôpital Saint Antoine, Paris, France jeremie.lefevre@aphp.fr.; Gut, Liver & Microbiome Research (GLIMMER) FHU, Paris, France. |
| Source: | BMJ open gastroenterology [BMJ Open Gastroenterol] 2026 Jun 12; Vol. 13 (1). Date of Electronic Publication: 2026 Jun 12. |
| Publication Type: | Clinical Trial Protocol; Journal Article |
| Journal Info: | Publisher: BMJ Publishing Group Ltd & British Society of Gastroenterology Country of Publication: England NLM ID: 101660690 Publication Model: Electronic Cited Medium: Print ISSN: 2054-4774 (Print) Linking ISSN: 20544774 NLM ISO Abbreviation: BMJ Open Gastroenterol Subsets: MEDLINE |
| Database: | MEDLINE Ultimate |
| FullText | Text: Availability: 0 |
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| Header | DbId: mdl DbLabel: MEDLINE Ultimate An: 42285586 AccessLevel: 2 PubType: Academic Journal PubTypeId: academicJournal PreciseRelevancyScore: 0 |
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| Items | – Name: Title Label: Title Group: Ti Data: Safety and effectiveness of the Colovac anastomosis protection device compared with diverting ileostomy after low anterior resection: protocol for an international, multicentre, prospective, non-randomised comparative study (SAFE-3). – Name: Author Label: Authors Group: Au Data: <searchLink fieldCode="AU" term="%22Pastier+C%22">Pastier C</searchLink>; Department of Digestive Surgery, Sorbonne University, AP-HP, Hôpital Saint Antoine, Paris, France.; Gut, Liver & Microbiome Research (GLIMMER) FHU, Paris, France.<br /><searchLink fieldCode="AU" term="%22Sylla+P%22">Sylla P</searchLink>; Department of Surgery, Icahn School of Medicine at Mount Sinai, New york, New York, USA.<br /><searchLink fieldCode="AU" term="%22Lee+SW%22">Lee SW</searchLink>; Division of Colon and Rectal Surgery, University of Southern California, Los Angeles, California, USA.<br /><searchLink fieldCode="AU" term="%22Spinelli+A%22">Spinelli A</searchLink>; Department of Biomedical Sciences, Humanitas University, Milan, Italy.; IRCCS Humanitas Research Hospital, Rozzano, Milan, Italy.<br /><searchLink fieldCode="AU" term="%22Komen+N%22">Komen N</searchLink>; Department of Abdominal Surgery, Antwerp University Hospital, Edegem, Belgium.; Antwerp RESURG Group, Antwerp Surgical Training, Anatomy and Research Centre (ASTARC), Faculty of Medicine and Health Sciences, University of Antwerp, Wilrijk, Belgium.<br /><searchLink fieldCode="AU" term="%22Marks+J%22">Marks J</searchLink>; Lankenau Medical Center, Main Line Health, Wynnewood, Pennsylvania, USA.<br /><searchLink fieldCode="AU" term="%22Martz+J%22">Martz J</searchLink>; Division of Colon and Rectal Surgery, Lenox Hill Hospital, New York, New York, USA.<br /><searchLink fieldCode="AU" term="%22Rhee+R%22">Rhee R</searchLink>; Department of Surgery, Maimonides Medical Center, Brooklyn, New York, USA.<br /><searchLink fieldCode="AU" term="%22Maykel+J%22">Maykel J</searchLink>; Department of Surgery, UMass Memorial Medical Center, Worcester, Massachusetts, USA.<br /><searchLink fieldCode="AU" term="%22Marcet+J%22">Marcet J</searchLink>; Division of Colon and Rectal Surgery, University of South Florida, Tampa, Florida, USA.<br /><searchLink fieldCode="AU" term="%22Denost+Q%22">Denost Q</searchLink>; Department of General and Digestive Surgery, Bordeaux Colorectal Institute, Bordeaux, France.<br /><searchLink fieldCode="AU" term="%22Zaghiyan+K%22">Zaghiyan K</searchLink>; Department of Surgery, Cedars-Sinai Medical Center, Los Angeles, California, USA.<br /><searchLink fieldCode="AU" term="%22Davids+JS%22">Davids JS</searchLink>; Department of Surgery, Boston University Chobanian & Avedisian School of Medicine, Boston Medical Center, Boston, Massachusetts, USA.<br /><searchLink fieldCode="AU" term="%22Paluvoi+N%22">Paluvoi N</searchLink>; Division of Colon and Rectal Surgery, Department of Surgery, University of Miami, Miller School of Medicine, Coral Gables, Florida, USA.<br /><searchLink fieldCode="AU" term="%22Hiller+D%22">Hiller D</searchLink>; Novant Health Colon & Rectal Clinic, Clemmons, North Carolina, USA.<br /><searchLink fieldCode="AU" term="%22McLemore+EC%22">McLemore EC</searchLink>; Department of Clinical Science, Kaiser Permanente Bernard J. Tyson School of Medicine, Richmond, California, USA.; Colon and Rectal Surgery Research Chair, LAMC General Surgery Residency, Kaiser Permanente Los Angeles Medical Center (LAMC), Los Angeles, California, USA.<br /><searchLink fieldCode="AU" term="%22Maggiori+L%22">Maggiori L</searchLink>; Department of General-Endocrine and Digestive Surgery, Saint Louis Hospital, Paris, France.<br /><searchLink fieldCode="AU" term="%22D'hoore+A%22">D'hoore A</searchLink>; Department of Abdominal Surgery, University Hospitals Leuven, Leuven, Belgium.<br /><searchLink fieldCode="AU" term="%22Jafari+MD%22">Jafari MD</searchLink>; New York-Presbyterian-Weill Cornell, New York, New York, USA.<br /><searchLink fieldCode="AU" term="%22Poylin+V%22">Poylin V</searchLink>; Department of Surgery, Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA.<br /><searchLink fieldCode="AU" term="%22Buzas+CJ%22">Buzas CJ</searchLink>; Department of General and Colorectal Surgery, Geisinger Medical Center, Danville, Pennsylvania, USA.<br /><searchLink fieldCode="AU" term="%22Tuech+JJ%22">Tuech JJ</searchLink>; Department of Digestive Surgery, Rouen University Hospital, Rouen, France.<br /><searchLink fieldCode="AU" term="%22Lefèvre+JH%22">Lefèvre JH</searchLink>; Department of Digestive Surgery, Sorbonne University, AP-HP, Hôpital Saint Antoine, Paris, France jeremie.lefevre@aphp.fr.; Gut, Liver & Microbiome Research (GLIMMER) FHU, Paris, France. – Name: TitleSource Label: Source Group: Src Data: <searchLink fieldCode="JN" term="%22101660690%22">BMJ open gastroenterology</searchLink> [BMJ Open Gastroenterol] 2026 Jun 12; Vol. 13 (1). <i>Date of Electronic Publication: </i>2026 Jun 12. – Name: TypePub Label: Publication Type Group: TypPub Data: Clinical Trial Protocol; Journal Article – Name: TitleSource Label: Journal Info Group: Src Data: <i>Publisher: </i><searchLink fieldCode="PB" term="%22BMJ+Publishing+Group+Ltd+%26+British+Society+of+Gastroenterology%22">BMJ Publishing Group Ltd & British Society of Gastroenterology </searchLink><i>Country of Publication: </i>England <i>NLM ID: </i>101660690 <i>Publication Model: </i>Electronic <i>Cited Medium: </i>Print <i>ISSN: </i>2054-4774 (Print) <i>Linking ISSN: </i><searchLink fieldCode="IS" term="%2220544774%22">20544774 </searchLink><i>NLM ISO Abbreviation: </i>BMJ Open Gastroenterol <i>Subsets: </i>MEDLINE |
| PLink | https://search.ebscohost.com/login.aspx?direct=true&site=eds-live&db=mdl&AN=42285586 |
| RecordInfo | BibRecord: BibEntity: Identifiers: – Type: doi Value: 10.1136/bmjgast-2025-002235 Languages: – Code: eng Text: English Titles: – TitleFull: Safety and effectiveness of the Colovac anastomosis protection device compared with diverting ileostomy after low anterior resection: protocol for an international, multicentre, prospective, non-randomised comparative study (SAFE-3). Type: main BibRelationships: HasContributorRelationships: – PersonEntity: Name: NameFull: Pastier C – PersonEntity: Name: NameFull: Sylla P – PersonEntity: Name: NameFull: Lee SW – PersonEntity: Name: NameFull: Spinelli A – PersonEntity: Name: NameFull: Komen N – PersonEntity: Name: NameFull: Marks J – PersonEntity: Name: NameFull: Martz J – PersonEntity: Name: NameFull: Rhee R – PersonEntity: Name: NameFull: Maykel J – PersonEntity: Name: NameFull: Marcet J – PersonEntity: Name: NameFull: Denost Q – PersonEntity: Name: NameFull: Zaghiyan K – PersonEntity: Name: NameFull: Davids JS – PersonEntity: Name: NameFull: Paluvoi N – PersonEntity: Name: NameFull: Hiller D – PersonEntity: Name: NameFull: McLemore EC – PersonEntity: Name: NameFull: Maggiori L – PersonEntity: Name: NameFull: D'hoore A – PersonEntity: Name: NameFull: Jafari MD – PersonEntity: Name: NameFull: Poylin V – PersonEntity: Name: NameFull: Buzas CJ – PersonEntity: Name: NameFull: Tuech JJ – PersonEntity: Name: NameFull: Lefèvre JH IsPartOfRelationships: – BibEntity: Dates: – D: 12 M: 06 Text: 2026 Jun 12 Type: published Y: 2026 Identifiers: – Type: issn-print Value: 2054-4774 Numbering: – Type: volume Value: 13 – Type: issue Value: 1 Titles: – TitleFull: BMJ open gastroenterology Type: main |
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