[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100435395":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":24,"centralContacts":32,"locations":40,"responsibleParty":63,"collaborators":66,"id":71,"slug":72,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":75,"acronym":18,"eligibilityCriteria":76,"healthyVolunteers":77,"sex":78,"minAge":79,"maxAge":80,"enrollmentInfo":81,"targetDuration":18,"studyType":84,"phases":85,"briefSummary":87,"conditions":88,"keywords":90,"overallStatus":43,"whyStopped":18,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":107},{"fullName":5,"class":6},"Larissa University Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"pIONM","EXPERIMENTAL","In the experimental group pIONM will be performed intraoperatively. For the implementation of pIONM, a special device, that allows simultaneous monitoring of sphincter signals and bladder manometry, will be introduced. This device will employ the placement of a bipolar electrode in the internal and external anal sphincter. Moreover, another electrode will be placed on the surrounding tissues. For bladder manometry, the catheter will be connected to the pressure sensor, and subsequently to the pIONM monitor. Intraoperatively, depending on the approach (open or laparoscopic), the respective bipolar stimulator will be used.\n\nPrior to the initiation of pIONM, urinary bladder will be drained and filled with 200 ml R\u002FL. The pIONM parameters will be the following: 1-25 milliampere current, 30 Hz frequency and 200 μs monophasic pulses.",[13],"Other: Pelvic Intraoperative Neuromonitoring",{"label":15,"type":16,"description":17,"interventionNames":18},"Control","NO_INTERVENTION","In the control group pIONM will not be performed intraoperatively",null,[20],{"type":6,"name":21,"description":22,"armGroupLabels":23,"otherNames":18},"Pelvic Intraoperative Neuromonitoring","Pelvic Intraoperative Neuromonitoring (pIONM) allows mapping of the pelvic autonomous plexus during total mesorectal excision (TME).",[9],[25,29],{"name":26,"affiliation":27,"role":28},"Konstantinos Tepetes, Prof","Department of Surgery, University Hospital of Larissa","STUDY_DIRECTOR",{"name":30,"affiliation":27,"role":31},"Konstantinos Perivoliotis, MD","PRINCIPAL_INVESTIGATOR",[33,37],{"name":26,"role":34,"phone":35,"phoneExt":18,"email":36},"CONTACT","00302413502804","tepetesk@gmail.com",{"name":30,"role":34,"phone":38,"phoneExt":18,"email":39},"00302413501000","kperi19@gmail.com",[41],{"facility":42,"status":43,"city":44,"state":18,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"University Hospital of Larissa","RECRUITING","Larissa","41110","Greece","GR",{"type":49,"coordinates":50},"Point",[51,52],22.42112,39.62847,{"lat":52,"lon":51},[55,56,59,61],{"name":26,"role":34,"phone":35,"phoneExt":18,"email":36},{"name":57,"role":58,"phone":18,"phoneExt":18,"email":18},"Anastasios Manolakis, PhD","SUB_INVESTIGATOR",{"name":60,"role":58,"phone":18,"phoneExt":18,"email":18},"Michael Samarinas, PhD",{"name":62,"role":58,"phone":18,"phoneExt":18,"email":18},"Aikaterini Tsiogga, MSc",{"type":31,"investigatorFullName":64,"investigatorTitle":65,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"Perivoliotis Konstantinos","Perivoliotis Konstantinos, Principal Investigator",[67,69],{"name":68,"class":6},"General Hospital of Larissa",{"name":70,"class":6},"University of Thessaly","100435395","intraoperative-neuromonitoring-of-pelvic-autonomous-nerve-plexus-during-total-mesorectal-excision-100435395",false,"NCT04949646","Intraoperative Neuromonitoring of Pelvic Autonomous Nerve Plexus During Total Mesorectal Excision","Inclusion Criteria:\n\n* Histologically confirmed rectal cancer\n* Surgical resection with TME\n* \\\u003C90 years old\n* Signed informed consent\n\nExclusion Criteria:\n\n* Emergency operation\n* Presence of pacemaker\n* Partial mesorectal excision\n* Sepsis or systematic infection\n* Physical or mental impairment\n* Pregnancy or nursing\n* Insufficient preoperative data for the urogenital\u002F anorectal function\n* Lack of compliance with the research process",true,"ALL","18 Years","90 Years",{"count":82,"type":83},44,"ESTIMATED","INTERVENTIONAL",[86],"NA","The purpose of this research protocol is the evaluation of the improvement of the anorectal and urogenital urinary function, alongside the postoperative quality of life after the application of pIONM in patients submitted to TME for rectal cancer.",[89],"Rectal Neoplasms",[91,92,93,94,95,96,97],"intraoperative","neuromonitoring","pelvic","autonomous","total","mesorectal","excision","2025-09-03",{"date":100,"type":101},"2025-09-04","ACTUAL",{"date":103,"type":101},"2021-09-19",{"date":105,"type":83},"2028-09-19",{"name":5,"class":6},1]