[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100649200":3},{"organization":4,"armGroups":7,"interventions":29,"overallOfficials":35,"centralContacts":44,"locations":50,"responsibleParty":82,"collaborators":87,"id":95,"slug":96,"hasResults":97,"nctId":98,"briefTitle":99,"officialTitle":100,"acronym":101,"eligibilityCriteria":102,"healthyVolunteers":97,"sex":103,"minAge":104,"maxAge":35,"enrollmentInfo":105,"targetDuration":35,"studyType":108,"phases":109,"briefSummary":111,"conditions":112,"keywords":118,"overallStatus":66,"whyStopped":35,"lastUpdateSubmitDate":133,"lastUpdatePostDateStruct":134,"startDateStruct":137,"completionDateStruct":139,"leadSponsor":141,"locationsCount":142},{"fullName":5,"class":6},"Fatih Sultan Mehmet Training and Research Hospital","OTHER",[8,14,20,25],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm 1 - Control (no diet + standard neuromuscular blockade NMB)","ACTIVE_COMPARATOR","Usual care: standard (moderate) neuromuscular blockade (train-of-four 1-2, intermittent bolus) and no dietary restriction. No mechanical bowel preparation.",[13],"Drug: Standard (moderate) neuromuscular blockade",{"label":15,"type":16,"description":17,"interventionNames":18},"Arm 2 - Diet + standard NMB","EXPERIMENTAL","Three-day preoperative low-residue diet with standard (moderate) neuromuscular blockade. No mechanical bowel preparation.",[13,19],"Other: Preoperative low-residue diet",{"label":21,"type":16,"description":22,"interventionNames":23},"Arm 3 - Deep NMB (no diet)","Deep neuromuscular blockade (post-tetanic count 1-2, continuous infusion) with no dietary restriction. No mechanical bowel preparation.",[24],"Drug: Deep Neuromuscular Blockade (NMB)",{"label":26,"type":16,"description":27,"interventionNames":28},"Arm 4 - Bundle (diet + deep NMB)","Three-day low-residue diet AND deep neuromuscular blockade - the combination of interest. No mechanical bowel preparation.",[24,19],[30,36,40],{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":35},"DRUG","Deep Neuromuscular Blockade (NMB)","Rocuronium by continuous infusion to maintain profound relaxation (no train-of-four twitches; post-tetanic count 1-2) until the end of the field measurement and surgery; reversed with sugammadex and confirmation of full recovery (train-of-four ratio ≥ 0.9) before extubation.\n\nCross-reference to arms: Arms 3, 4",[21,26],null,{"type":31,"name":37,"description":38,"armGroupLabels":39,"otherNames":35},"Standard (moderate) neuromuscular blockade","Rocuronium by intermittent bolus to maintain a train-of-four count of 1-2 (usual care); reversed with sugammadex and confirmation of full recovery (train-of-four ratio ≥ 0.9) before extubation.\n\nCross-reference to arms: Arms 1, 2",[9,15],{"type":6,"name":41,"description":42,"armGroupLabels":43,"otherNames":35},"Preoperative low-residue diet","A low-residue diet (less than 10 g dietary fibre per day) for the three days before surgery, with standardised food lists and a patient information sheet. This is a dietary measure, not a laxative; no mechanical bowel preparation is used.\n\nCross-reference to arms: Arms 2, 4",[15,26],[45],{"name":46,"role":47,"phone":48,"phoneExt":35,"email":49},"MURAT Y Murat Yassa, MD (Assoc. Prof.) - Principal Investigator, ASSOCIATE PROFESSOR IN OBS GYN","CONTACT","+905335106312","murat.yassa@acibadem.com",[51,64,73],{"facility":52,"status":53,"city":54,"state":55,"zip":56,"country":57,"countryCode":35,"cosmosGeoPoint":58,"geoPoint":63,"contacts":35},"Kartal Dr. Lütfi Kırdar Şehir Hastanesi","ACTIVE_NOT_RECRUITING","Istanbul","KARTAL","34865","Turkey (Türkiye)",{"type":59,"coordinates":60},"Point",[61,62],28.94966,41.01384,{"lat":62,"lon":61},{"facility":65,"status":66,"city":54,"state":55,"zip":35,"country":57,"countryCode":35,"cosmosGeoPoint":67,"geoPoint":69,"contacts":70},"Acibadem Kartal Hospital","RECRUITING",{"type":59,"coordinates":68},[61,62],{"lat":62,"lon":61},[71],{"name":72,"role":47,"phone":48,"phoneExt":35,"email":49},"MURAT Y Murat Yassa, MD - Principal Investigator, MD, Assoc. Prof.",{"facility":74,"status":53,"city":75,"state":75,"zip":76,"country":57,"countryCode":35,"cosmosGeoPoint":77,"geoPoint":81,"contacts":35},"Kütahya Şehir Hastanesi","Kütahya","43100",{"type":59,"coordinates":78},[79,80],29.98333,39.42417,{"lat":80,"lon":79},{"type":83,"investigatorFullName":84,"investigatorTitle":85,"investigatorAffiliation":86,"oldNameTitle":35,"oldOrganization":35},"PRINCIPAL_INVESTIGATOR","MURAT YASSA","Head of the Department","Acibadem University",[88,90,93],{"name":89,"class":6},"Kutahya City Hospital",{"name":91,"class":92},"Kocaeli City Hospital","OTHER_GOV",{"name":94,"class":92},"Dr. Lutfi Kirdar Kartal Training and Research Hospital","100649200","deep-neuromuscular-blockade-and-a-low-residue-diet-for-the-surgical-field-in-vnotes-hysterectomy-100649200",false,"NCT07730970","Deep Neuromuscular Blockade and a Low-Residue Diet for the Surgical Field in vNOTES Hysterectomy","Effect of Deep Neuromuscular Blockade and a Preoperative Low-Residue Diet on Intra-operative Surgical Field Conditions During Vaginal Natural Orifice Transluminal Endoscopic Surgery (vNOTES) Hysterectomy: A 2×2 Factorial, Assessor-Blinded Randomized Controlled Trial","vNOTES_NMBDIET","Inclusion Criteria:\n\n* Adult women (aged 18 years or older) scheduled for hysterectomy for a benign (non-cancer) indication.\n* Judged suitable for the vNOTES approach by the operating surgeon.\n* Able to understand the study and provide written informed consent.\n\nExclusion Criteria:\n\n* Suspected or known gynaecological malignancy.\n* Conditions expected to make the approach or the field assessment non-standard (e.g., anticipated dense pelvic adhesions or severe endometriosis, a contraindication to vNOTES, or an obliterated cul-de-sac).\n* Any medical reason why deep neuromuscular blockade or sugammadex would be unsafe (defined with the anaesthesia team).\n* Any medical reason why a low-residue diet would be unsuitable.\n* Inability to give informed consent.","FEMALE","18 Years",{"count":106,"type":107},160,"ESTIMATED","INTERVENTIONAL",[110],"NA","vNOTES (vaginal natural orifice transluminal endoscopic surgery) hysterectomy is performed entirely through the vagina, with no abdominal incision. A clear surgical view is essential, and the main obstacle to the view is bowel falling into the pelvis. This randomized trial tests whether two simple measures improve the surgical field, individually or in combination: a preoperative low-residue diet for three days, and deeper intra-operative muscle relaxation (deep neuromuscular blockade). No group receives mechanical bowel preparation.\n\nUsing a 2×2 factorial design, participants are allocated equally (1:1:1:1) to one of four groups: (1) no diet with standard relaxation; (2) diet with standard relaxation; (3) no diet with deep relaxation; (4) diet with deep relaxation (the \"bundle\"). The surgical field is measured objectively: during a standardized window the carbon-dioxide insufflation pressure is lowered step by step, and 2-3 blinded assessors score the field from de-identified video. The primary outcome is the lowest pressure at which the field remains adequate; a lower pressure indicates an intrinsically better field.\n\nThe trial hypothesis is an interaction - that the combination achieves an adequate field at a meaningfully lower pressure than either measure alone. The final sample size is determined from an internal pilot. Secondary outcomes include the continuous field score, the need for an additional instrument to clear the field, postoperative nausea and vomiting, and routine operative outcomes.",[113,114,115,116,117],"Leiomyoma, Uterine","Benign Gynecological Disease","Abnormal Uterine Bleeding (AUB)","Uterine Prolapse","Adenomyosis of Uterus",[119,120,121,122,123,124,125,126,127,128,129,130,131,132],"vNOTES","vaginal natural orifice transluminal endoscopic surgery","deep neuromuscular blockade","rocuronium","post-tetanic count","low-residue diet","bowel preparation","insufflation pressure","pneumoperitoneum","surgical field","visualization","objective visualisation index (OVI)","factorial trial","assessor-blinded","2026-07-29",{"date":135,"type":136},"2026-07-30","ACTUAL",{"date":138,"type":136},"2026-07-01",{"date":140,"type":107},"2027-09-01",{"name":5,"class":6},3]