[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100520812":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":26,"locations":20,"responsibleParty":36,"collaborators":39,"id":42,"slug":43,"hasResults":44,"nctId":45,"briefTitle":9,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":44,"sex":49,"minAge":50,"maxAge":20,"enrollmentInfo":51,"targetDuration":20,"studyType":54,"phases":55,"briefSummary":57,"conditions":58,"keywords":62,"overallStatus":69,"whyStopped":20,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":20},{"fullName":5,"class":6},"Nicolaus Copernicus University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Endoscopic Ultrasound- Guided Hartmann Reversal Procedure","EXPERIMENTAL","Participants after Hartmann procedure, who were qualified and underwent Endoscopic Ultrasound- Guided Hartmann Reversal Procedure.",[13],"Procedure: Endoscopic restoration of gastrointestinal continuity after Hartmann procedure",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"PROCEDURE","Endoscopic restoration of gastrointestinal continuity after Hartmann procedure","EndoHARP is a new technique proposed to restore gastrointestinal continuity after the Hartmann's procedure. For EndoHARP, a fixed loop of the large intestine will be identified on endosonography after an echoendoscope is inserted into the rectal stump under endoscopic guidance. Then, using the set for inserting self-expandable metal transmural endoprosthesis (20 mm in diameter and 10 mm in length) with electrocautery (as in endoscopic gastroenterostomy), EUS-guided anastomosis of the rectal stump to the large intestine loop will be performed, allowing the natural passage of intestinal contents through the endoscopic anastomosis, restoring gastrointestinal continuity. The aim of leaving the self-expandable transmural endoprosthesis in the anastomosis is not only to maintain the patency of the intestinal anastomosis of at least 20 mm in diameter, but also to diminish the risk of endoscopic intestinal anastomotic leak by completely covering the prosthesis with a polymer layer.",[9],null,[22],{"name":23,"affiliation":24,"role":25},"Mateusz Jagielski, Prof.","Department of General, Gastroenterological and Oncological Surgery, Collegium Medicum, Nicolaus Copernicus University in Toruń, Poland","PRINCIPAL_INVESTIGATOR",[27,32],{"name":23,"role":28,"phone":29,"phoneExt":30,"email":31},"CONTACT","56 679-31-99","+48","matjagiel@gmail.com",{"name":33,"role":28,"phone":34,"phoneExt":30,"email":35},"Michał Spychalski, Ass. Prof.","46 875-25-01","mspych80@gmail.com",{"type":25,"investigatorFullName":37,"investigatorTitle":38,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"Mateusz Jagielski","Professor",[40],{"name":41,"class":6},"Medical University of Łódź","100520812","endoscopic-ultrasound--guided-hartmann-reversal-procedure-100520812",false,"NCT06061432","Endoscopic Reconstruction of the Gastrointestinal Tract After Surgical Resection Procedures Within the Large Intestine (Hartmann's Procedure- Modification of the Method Facilitating the Restoration of Gastrointestinal Continuity)","EndoHARP","Inclusion Criteria:\n\n* participants of both sexes aged above 18 years\n* participants, who provided informed consent for such treatment\n* eligibility for Hartmann's procedure according to current medical knowledge based on evidence-based medicine.\n\nExclusion Criteria:\n\n* pregnancy, breastfeeding, or intention to become pregnant during the study\n* contraindications to electrosurgical instruments\n* allergy to any of the materials used in the study\n* participants with advanced cancer in the metastatic stage\n* participants ineligible for restoration of gastrointestinal continuity\n* participants ineligible for surgery\n* participants ineligible for general anesthesia","ALL","18 Years",{"count":52,"type":53},100,"ESTIMATED","INTERVENTIONAL",[56],"NA","The goal of this clinical trial is to learn about clinical usefulness endoscopic gastrointestinal anastomoses to restore the gastrointestinal continuity in patients with permanent colostomy after Hartmann procedure.\n\nThe main questions it aims to answer are:\n\n* is the endoscopic restore the gastrointestinal continuity procedure effective?\n* is this endoscopic procedure safe?",[59,60,61],"Colorectal Neoplasms","Diverticular Diseases","Inflammatory Bowel Diseases",[63,64,65,66,67,68],"colorectal surgery","endotherapy","anastomosis","endoscopic ultrasound","gastrointestinal continuity","Hartmann procedure","NOT_YET_RECRUITING","2023-09-24",{"date":72,"type":73},"2023-09-29","ACTUAL",{"date":75,"type":53},"2023-12-01",{"date":77,"type":53},"2026-12-31",{"name":5,"class":6}]