[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"anastomotic-leaks\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:anastomotic-leaks":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,42,79,118,149],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100595667","endo-sponge-for-treatment-of-anastomotic-or-hartmanns-stump-leakages-in-lower-pelvic-area-100595667",false,"NCT07035431","Endo-SPONGE for Treatment of Anastomotic or Hartmann's Stump Leakages in Lower Pelvic Area","A Prospective Multicenter Trial Evaluating the Safety and Effectiveness of Endo-SPONGE for the Treatment of Anastomotic or Hartmann's Stump Leakages in the Lower Pelvic Area","DRAIN Lower","Inclusion Criteria:\n\n* Confirmed grade B anastomotic leak as per the ISGRC (International Study Group of Rectal Cancer) grading system after colorectal surgery.\n* Subject is eligible for endoscopic intervention.\n* Subject has a transmural defect of at least 2 cm in diameter following colorectal surgery in the lower pelvic area.\n* Subject has an anastomotic or Hartmann's stump leak located within an extraperitoneal cavity.\n* Subject has pre-existing diverting ostomy or an ostomy created prior to the first Endo-SPONGE placement.\n* Subject understands the trial requirements and is willing and able to comply with the study procedures, all protocol-required follow up evaluations and provide written informed consent to participate in the study.\n* Investigator decision that EVT is the most suitable treatment of the available treatment options.\n\nExclusion Criteria:\n\n* Subject is under 18 years of age.\n* Potentially vulnerable subject, including, but not limited to pregnant women.\n* Subject has undergone EVT or other similar interventions for the current colorectal indication.\n* Subject had colorectal surgery more than 60 days prior to the planned study procedure.\n* Subject has any necrotic tissue that would require endoscopic debridement prior to Endo-SPONGE placement.\n* Subject has known contraindication for EVT as per the IB.\n* Subject is currently enrolled in another investigational study that would directly interfere with the current study, without prior written approval from the sponsor.","ALL","18 Years",{"count":20,"type":21},66,"ESTIMATED","INTERVENTIONAL",[24],"NA","This study is intended to evaluate the safety and effectiveness of Sponge-based Endoscopic Vacuum Therapy (EVT) using Endo-SPONGE for the treatment of Anastomotic Leaks (AL) or Hartmann's stump leakages following colorectal surgery in a prospective multi-center study.",[27,28],"Anastomotic Leaks","Hartmanns Stump Leakage","RECRUITING","2026-06-17",{"date":32,"type":33},"2026-06-18","ACTUAL",{"date":35,"type":21},"2026-07",{"date":37,"type":21},"2028-12",{"name":39,"class":40},"Boston Scientific Corporation","INDUSTRY",9,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":22,"phases":52,"briefSummary":53,"conditions":54,"keywords":65,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":41},"100619934","post-market-study-of-the-signia-circular-stapler-with-tri-staple-technology-in-left-sided-colon-sigmoid-and-rectal-resections-100619934","NCT07351071","Post-Market Study of the Signia Circular Stapler With Tri-Staple Technology in Left-sided Colon, Sigmoid, and Rectal Resections","A Prospective, Multicenter, Single-arm, Post Market Study to Evaluate the Safety and Performance of the Signia™ Circular Stapler With Tri-Staple™ Technology in Elective Open or Minimally Invasive Left-sided Colon, Sigmoid, and Rectal Resections (SECURE)","SECURE","Preoperative Inclusion Criteria:\n\n1. Subject is competent and willing to provide documented informed consent to participate in this clinical study\n2. Subject is intended to undergo an elective left sided colon\u002Fcolorectal procedure where a creation of an anastomosis will be completed with the Signia™ circular stapler\n3. Subject is ≥ 18 years of age at time of consent\n\nPreoperative Exclusion Criteria:\n\n1. Subject is unable or unwilling to comply with the study requirements or follow-up schedule\n2. Subject with ASA classification ≥ IV\n3. Subject is pregnant (as determined by standard site practices)\n4. The procedure is an emergency procedure\n5. The procedure is a revision\u002Freoperation for the same indication\n6. The subject has a documented confounding medical condition which in the opinion of the investigator, will not be appropriate for the study, or the subject has an estimated life expectancy of less than 6 months\n7. Subject has participated or plans to participate in an investigational drug or device research study that would interfere with the results of this study\n8. Subject will undergo multiple synchronous colon resections\n9. Subject with a bleeding disorder or is undergoing anticoagulant treatment that has not been reversed (anticoagulant prophylaxis prescribed as part of the surgical protocol is allowed)\n10. Subject has undergone chemotherapy or received biologics within 6 weeks prior to the day of the procedure\n11. Subject has history of chronic corticosteroid use (used greater than 3 months within a year prior to the index procedure)\n12. Subject has chronic immunosuppression therapy (used greater than 3 months within a year prior to the index procedure)\n13. Any subject undergoing an ileal-anal pouch anastomosis surgery\n\nIntraoperative Exclusion Criteria\n\n1. Anastomosis not attempted with the Signia™ circular stapler\n2. Any subject for which the device is intended to be used outside the instructions for use (IFU)",{"count":51,"type":21},137,[24],"The purpose of this study is to evaluate the safety and performance of the Signia™ power handle, Signia™ circular adapter, and Signia™ Tri-Staple™ 2.0 circular reloads (hereafter referred to as Signia™ circular stapler) in patients undergoing left sided colon, sigmoid, or rectal resections in a post market setting.",[55,56,57,58,59,60,61,62,63,64,27],"Colorectal Anastomosis","Left-sided Colon Resection","Anastomotic Leak","Anastomotic Complication","Digestive System Diseases","Gastrointestinal Diseases","Colonic Diseases","Intestinal Diseases","Rectal Diseases","Postoperative Complications",[55,56,66,57,67,68,69],"Circular stapler","Rectal cancer","Low anterior resection","Powered stapler","2026-06-11",{"date":72,"type":33},"2026-06-12",{"date":74,"type":33},"2025-12-30",{"date":76,"type":21},"2027-02-28",{"name":78,"class":40},"Medtronic - MITG",{"id":80,"slug":81,"hasResults":11,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":85,"eligibilityCriteria":86,"healthyVolunteers":11,"sex":87,"minAge":18,"maxAge":4,"enrollmentInfo":88,"targetDuration":4,"studyType":22,"phases":90,"briefSummary":92,"conditions":93,"keywords":99,"overallStatus":106,"whyStopped":4,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":117},"100583089","phase-4-near-infrared-fluorescence-imaging-with-indocyanine-green-to-evaluate-bowel-anastomoses-in-gynecologic-oncology-surgery-100583089","NCT06871787","Near-Infrared Fluorescence Imaging With Indocyanine Green to Evaluate Bowel Anastomoses in Gynecologic Oncology Surgery","Evaluation of Bowel Anastomoses During Gynecologic Oncology Surgery Using Near-Infrared Fluorescence Imaging With Indocyanine Green","INOCA","Inclusion Criteria:\n\n* Female patients aged 18 years or older.\n* Diagnosis of gynecologic cancer (ovarian, endometrial, cervical, vulvar) requiring surgical treatment.\n* Planned bowel resection and anastomosis during gynecologic oncology surgery.\n* Ability and willingness to provide informed consent.\n\nExclusion Criteria:\n\n* Known allergy or hypersensitivity to indocyanine green (ICG).\n* Pregnancy or breastfeeding at the time of surgery.\n* Severe liver or kidney dysfunction limiting the use of ICG.","FEMALE",{"count":89,"type":21},50,[91],"PHASE4","The goal of this study is to evaluate if indocyanine green (ICG) fluorescence imaging helps reduce complications in bowel surgery performed during gynecologic cancer operations.\n\nThe main question it aims to answer is: Does using ICG fluorescence imaging during bowel anastomosis reduce the rate of complications such as leaks, infections, and abscesses within 30 days after surgery? Participants are women aged 18 and older undergoing surgery for gynecologic cancers (such as ovarian, uterine, cervical, or vulvar cancer). During surgery, investigators will inject ICG intravenously, then use a special near-infrared camera to see how well blood flows at the anastomosis site. The investigators will then decide if the reconnection is good enough or needs adjustment.\n\nResearchers will record any complications within the first 30 days after surgery to understand if this imaging method helps reduce surgical risks.",[94,95,96,97,98,27],"Gynecologic Cancers","Ovarian Cancer","Endometrial Cancers","Cervical Cancers","Vulvar Cancer",[100,101,102,103,104,105],"Indocyanine Green","Near-Infrared Imaging","Bowel Anastomosis","Gynecologic Oncology","Anastomotic Complications","Perfusion Assessment","NOT_YET_RECRUITING","2025-03-11",{"date":109,"type":33},"2025-03-14",{"date":111,"type":21},"2025-09-01",{"date":113,"type":21},"2027-12-30",{"name":115,"class":116},"Istanbul University","OTHER",1,{"id":119,"slug":120,"hasResults":11,"nctId":121,"briefTitle":122,"officialTitle":122,"acronym":123,"eligibilityCriteria":124,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":125,"targetDuration":127,"studyType":128,"phases":4,"briefSummary":129,"conditions":130,"keywords":136,"overallStatus":106,"whyStopped":4,"lastUpdateSubmitDate":140,"lastUpdatePostDateStruct":141,"startDateStruct":143,"completionDateStruct":145,"leadSponsor":147,"locationsCount":117},"100570559","augur-ai---indocyanine-green-fluorescence-angiography-representer-100570559","NCT06708819","AUGUR-AI - Indocyanine Green Fluorescence Angiography Representer","AUGUR-AI","Inclusion Criteria:\n\n* Participant is willing and able to give informed consent for participation in the study.\n* Aged 18 years or above.\n* Colorectal disease requiring segmental resection with anastomosis.\n* Participant has clinically acceptable laboratory results, including liver function tests.\n* In the Investigator's opinion, is able and willing to comply with all study requirements.\n* Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the study.\n\nExclusion Criteria:\n\nThe participant may not enter the study if ANY of the following apply:\n\n* Participant who is pregnant, lactating or planning pregnancy during the course of the study.\n* Significant renal or hepatic impairment.\n* Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study.\n* Allergy to intravenous contrast agent or indocyanine green.\n* Concurrent use of anticonvulsants, bisulphite containing drugs, methadone and nitrofurantoin.",{"count":126,"type":21},300,"90 Days","OBSERVATIONAL","Surgery can effectively treat colorectal cancer, but it is a complex procedure with risks and complications. Surgeons often rely on cameras to visually guide their instruments during operations, especially in minimally invasive (\"keyhole\") and endoscopic procedures. The camera is connected to a computer and generates the internal scene onto a display screen, which the surgeon looks at throughout the procedure, helping them make informed decisions throughout the operation. Fluorescence-guided surgery uses a particular type of camera that can detect images in both normal light and in the near-infrared range. To work, it needs the administration of an agent called indocyanine green to a patient and then the camera can see if the agent is in the tissue of interest to the operation at the time of the surgery. In this way, decisions regarding blood supply (\"perfusion\") can be helped, especially related to safety in joining together portions of tissue after removal of disease. The equipment and agent are approved for use in this way and have very good safety profiles. Many international studies have already demonstrated that the use of fluorescence-guided surgery is associated with lower rates of leaks when disease bowel segments are removed, and the healthy ends are joined back together.\n\nPrevious work we have done has shown that sophisticated computing methods can learn to interpret the fluorescence patterns to a similar standard as a surgeon who is very experienced in fluorescence-guided surgery.\n\nIn this study, we aim to assess whether the computer system we have developed work in real-time, in theatre to provide a reliable interpretation of the fluorescence pattern, that would match how an expert would interpret the same pattern. The system's analysis will not impact on the operation; instead, video images will be recorded, processed and analysed by our computer system. The results of the interpretation will not be shown to the operating surgeon during the procedure to avoid any impact on decision-making.",[131,132,133,134,100,135,27],"Colorectal Surgery","Colorectal Resection","Anastomosis, Surgical","Fluorescence Guided Surgery","Perfusion Imaging",[137,100,138,139,57],"Fluorescence","Artificial Intelligence","Bowel Transection","2024-11-26",{"date":142,"type":33},"2024-11-27",{"date":144,"type":21},"2025-01",{"date":146,"type":21},"2026-01",{"name":148,"class":116},"Mater Misericordiae University Hospital",{"id":150,"slug":151,"hasResults":11,"nctId":152,"briefTitle":153,"officialTitle":154,"acronym":155,"eligibilityCriteria":156,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":157,"targetDuration":4,"studyType":128,"phases":4,"briefSummary":159,"conditions":160,"keywords":167,"overallStatus":106,"whyStopped":4,"lastUpdateSubmitDate":172,"lastUpdatePostDateStruct":173,"startDateStruct":175,"completionDateStruct":177,"leadSponsor":179,"locationsCount":117},"100567777","intra-abdominal-hypertension-and-abdominal-compartment-syndrome-in-patients-after-pancreatic-procedures-100567777","NCT06672601","Intra-abdominal Hypertension and Abdominal Compartment Syndrome in Patients After Pancreatic Procedures.","The HYPA Study: Intra-abdominal Hypertension and Abdominal Compartment Syndrome in Patients Undergoing Open and Robotic Pancreatic Procedures","HYPA","Inclusion Criteria:\n\n* Patients ≥ 18-year-old\n* Indication for elective pancreatic procedure\n* Written informed consent\n\nExclusion Criteria:\n\n* Patients \\\u003C18 years old.\n* Contraindication for urinary catheter placement.\n* Refusal to participate in the study.",{"count":158,"type":21},150,"This study investigates the development of intra-abdominal hypertension and compartment syndrome in patients undergoing elective pancreatic procedures. Main objective is to determine the proportion of patients after pancreatic operation who develop elevated intra-abdominal pressure and assess its association with postoperative complication rates. Another goal of the study is to compare open versus robotic pancreatic procedures regarding the occurrence of intra-abdominal hypertension and abdominal compartment syndrome.",[161,162,163,164,165,27,166],"Intra Abdominal Pressure","Abdominal Compartment Syndrome","Pancreatic Surgery","Pancreatic Fistula After Pancreaticoduodenectomy","Delayed Gastric Emptying","Overload Fluid",[168,169,170,171],"Intra-abdominal hypertension","Compartment syndrome","Pancreatic surgery","Robotic surgery","2024-11-07",{"date":174,"type":33},"2024-11-08",{"date":176,"type":21},"2025-01-01",{"date":178,"type":21},"2028-03-31",{"name":180,"class":116},"Charles University, Czech Republic"]