[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100625032":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":29,"centralContacts":37,"locations":42,"responsibleParty":107,"collaborators":110,"id":115,"slug":116,"hasResults":117,"nctId":118,"briefTitle":119,"officialTitle":120,"acronym":121,"eligibilityCriteria":122,"healthyVolunteers":117,"sex":123,"minAge":124,"maxAge":10,"enrollmentInfo":125,"targetDuration":10,"studyType":128,"phases":10,"briefSummary":129,"conditions":130,"keywords":135,"overallStatus":45,"whyStopped":10,"lastUpdateSubmitDate":142,"lastUpdatePostDateStruct":143,"startDateStruct":146,"completionDateStruct":148,"leadSponsor":150,"locationsCount":151},{"fullName":5,"class":6},"Umeå University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Prospective single-stapled technique cohort",null,"Adult patients undergoing planned left-sided colorectal resection with colorectal anastomosis (including sigmoid resection, left hemicolectomy, or partial mesorectal excision) in whom the anastomosis is constructed using the single-stapled technique (SST) as part of routine clinical practice. Patients are included prospectively and followed for postoperative complications, including anastomotic leakage within 90 days, as well as longer-term outcomes.",[13],"Procedure: Single-stapled colorectal anastomosis",{"label":15,"type":10,"description":16,"interventionNames":17},"Retrospective double-stapled technique cohort","A retrospective cohort of adult patients who previously underwent planned left-sided colorectal resection with colorectal anastomosis using the conventional double-stapled technique (DST) during the years 2023-2025. Patients are identified through medical record review at participating centers using the same inclusion criteria as the prospective cohort, and outcome data are collected retrospectively for comparison.",[18],"Procedure: Double-stapled colorectal anastomosis",[20,25],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":10},"PROCEDURE","Single-stapled colorectal anastomosis","Construction of a colorectal anastomosis using a single-stapled technique, where the rectal staple line is excised and a purse-string suture is placed on the rectal stump and tied around the tip of a circular stapler, before completion of the anastomosis. The procedure is performed as part of routine clinical practice during planned left-sided colorectal resection.",[9],{"type":21,"name":26,"description":27,"armGroupLabels":28,"otherNames":10},"Double-stapled colorectal anastomosis","Construction of a colorectal anastomosis using the conventional double-stapled technique, where the rectal stump is closed with a linear stapler and the anastomosis is completed using a circular stapler and without excision of the rectal staple line. The procedure is performed as part of standard surgical practice.",[15],[30,34],{"name":31,"affiliation":32,"role":33},"Oskar Grahn, MD, PhD","Umea University \u002F Region Vasterbotten","PRINCIPAL_INVESTIGATOR",{"name":35,"affiliation":36,"role":33},"Martin Rutegård, MD, PhD","Ostra Sahlgrenska University Hospital, Gothenburg, Sweden",[38],{"name":31,"role":39,"phone":40,"phoneExt":10,"email":41},"CONTACT","+46907850000","oskar.grahn@umu.se",[43,59,72,84,94],{"facility":44,"status":45,"city":46,"state":10,"zip":10,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"Östra Sahlgrenska University Hospital","RECRUITING","Gothenburg","Sweden","SE",{"type":50,"coordinates":51},"Point",[52,53],11.96679,57.70716,{"lat":53,"lon":52},[56],{"name":35,"role":39,"phone":57,"phoneExt":10,"email":58},"+4631 342 10 00","martin.rutegard@vgregion.se",{"facility":60,"status":45,"city":61,"state":10,"zip":10,"country":47,"countryCode":48,"cosmosGeoPoint":62,"geoPoint":66,"contacts":67},"Sunderby Hospital","Luleå",{"type":50,"coordinates":63},[64,65],22.15465,65.58415,{"lat":65,"lon":64},[68],{"name":69,"role":39,"phone":70,"phoneExt":10,"email":71},"Christoffer Odensten, MD, PhD","+46920 28 20 00","christoffer.odensten@umu.se",{"facility":73,"status":45,"city":74,"state":10,"zip":10,"country":47,"countryCode":48,"cosmosGeoPoint":75,"geoPoint":79,"contacts":80},"Skåne University Hospital","Malmö",{"type":50,"coordinates":76},[77,78],13.00073,55.60587,{"lat":78,"lon":77},[81],{"name":82,"role":39,"phone":83,"phoneExt":10,"email":10},"Erik Agger, MD, PhD","+4640 33 10 00",{"facility":85,"status":45,"city":86,"state":10,"zip":10,"country":47,"countryCode":48,"cosmosGeoPoint":87,"geoPoint":91,"contacts":92},"Surgical Centre, Umeå University Hospital","Umeå",{"type":50,"coordinates":88},[89,90],20.25972,63.82842,{"lat":90,"lon":89},[93],{"name":31,"role":39,"phone":40,"phoneExt":10,"email":41},{"facility":95,"status":45,"city":96,"state":10,"zip":10,"country":47,"countryCode":48,"cosmosGeoPoint":97,"geoPoint":101,"contacts":102},"Uppsala University Hospital","Uppsala",{"type":50,"coordinates":98},[99,100],17.63889,59.85882,{"lat":100,"lon":99},[103],{"name":104,"role":39,"phone":105,"phoneExt":10,"email":106},"Malin Enblad, MD, PhD","+4618 611 00 00","malin.enblad@uu.se",{"type":33,"investigatorFullName":108,"investigatorTitle":109,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Oskar Grahn","MD, PhD",[111,113],{"name":112,"class":6},"Sahlgrenska University Hospital",{"name":114,"class":6},"Skane University Hospital","100625032","single-stapled-technique-for-colorectal-anastomosis-100625032",false,"NCT07417358","Single-Stapled Technique for Colorectal Anastomosis","Single-Stapled Technique for Colorectal Anastomosis After Left-Sided Colectomy, Sigmoid Resection or Partial Mesorectal Excision: A Multicentre Prospective Observational Cohort Study","SST","Inclusion Criteria:\n\n* Age ≥ 18 years.\n* Planned (elective) left-sided colorectal resection with creation of a colorectal anastomosis, including: Left hemicolectomy, and\u002For Sigmoid resection, and\u002For Partial mesorectal excision (PME).\n* Benign or malignant indication.\n* Prospective cohort: Ability to provide written informed consent.\n* Retrospective cohort: Eligible patients operated during 2023-2025 at participating centers, identified through medical record review, meeting the same surgical inclusion criteria.\n\nExclusion Criteria:\n\n* Total mesorectal excision (TME) (e.g., low rectal cancer surgery requiring TME).\n* Non-left-sided colorectal resections (e.g., right-sided colectomy) or procedures outside the study-defined operations.\n* Surgery not involving a colorectal anastomosis (e.g., end colostomy\u002FHartmann's procedure without anastomosis).\n* Emergency\u002Furgent colorectal resection (non-elective surgery).\n* Prospective cohort: Inability to provide informed consent.","ALL","18 Years",{"count":126,"type":127},500,"ESTIMATED","OBSERVATIONAL","The goal of this observational multicenter study is to evaluate the safety and feasibility of a single-stapled technique (SST) for colorectal anastomosis and to explore whether this technique is associated with a reduced rate of anastomotic leakage compared with the conventional double-stapled technique (DST).\n\nThe study includes adult patients undergoing planned left-sided colorectal resection with colorectal anastomosis, including sigmoid resection, left hemicolectomy, or partial mesorectal excision (PME), for benign or malignant disease.\n\nThe main questions it aims to answer are:\n\nWhat is the rate of anastomotic leakage within 90 days after surgery in patients operated with the single-stapled technique?\n\nIs the single-stapled technique feasible and safe across different surgical approaches (open, laparoscopic, and robot-assisted surgery) in a multicenter setting?\n\nFurthermore, outcomes after single-stapled anastomosis will be compared with a retrospective cohort of patients operated with the conventional double-stapled technique to explore potential differences in anastomotic leakage rates and postoperative complications.\n\nParticipants will receive standard surgical care as determined by the treating surgical team. Patients included in the prospective part of the study will undergo colorectal anastomosis using the single-stapled technique as part of routine clinical practice. Data on perioperative variables, postoperative complications (including anastomotic leakage graded according to international consensus definitions), and follow-up outcomes will be collected prospectively using an electronic case report form (eCRF). A retrospective cohort from the same participating centers will be identified through medical record review using identical inclusion criteria.\n\nThe results of this study are intended to provide robust multicenter data on the safety and clinical outcomes of the single-stapled technique and to serve as the basis for planning a future randomized controlled multicenter trial.",[131,132,133,134],"Colorectal Cancer","Colorectal Anastomosis","Anastomotic Leakage","Diverticular Disease of Left Side of Colon",[136,137,138,139,140,141],"Single-stapled anastomosis","Colorectal anastomosis","Anastomotic leakage","Colorectal surgery","Left-sided colon resection","Partial mesorectal excision","2026-02-10",{"date":144,"type":145},"2026-02-18","ACTUAL",{"date":147,"type":145},"2026-01-07",{"date":149,"type":127},"2029-06-30",{"name":5,"class":6},5]