[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"benign-gynecological-disease\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:benign-gynecological-disease":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,63],{"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":22,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":35,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":51,"lastUpdatePostDateStruct":52,"startDateStruct":55,"completionDateStruct":57,"leadSponsor":59,"locationsCount":62},"100652437","prospective-perioperative-clinical-registry-for-women-undergoing-benign-gynecological-surgery-100652437",false,"NCT07772076","Prospective Perioperative Clinical Registry for Women Undergoing Benign Gynecological Surgery","Prospective Observational Registry on the Collection of Perioperative Clinical Data in Gynecology","OPGYNBEN","Inclusion Criteria:\n\n1. Age \\>= 18 years\n2. Diagnosis of benign gynecological disease (e.g., uterine fibroids, endometriosis, pelvic neoplasm, endometrial polyp, endometrial hyperplasia, cervical dysplasia, pelvic adhesions, isthmocele, genital prolapse, adenomyosis, female genital malformations, pelvic inflammatory disease)\n3. Indication for elective benign gynecological surgery\n4. Signed written informed consent for data collection\n\nExclusion Criteria:\n\n1. Age \\\u003C 18 years\n2. Suspected or confirmed malignant gynecological disease\n3. Current pregnancy\n4. Emergency \u002F unscheduled surgical procedure\n5. No indication for surgery\n6. Refusal or inability to provide signed informed consent","FEMALE","18 Years",{"count":20,"type":21},6000,"ESTIMATED","3 Years","OBSERVATIONAL","This prospective observational registry aims to systematically collect preoperative, intraoperative, and postoperative clinical data from patients undergoing surgery for benign gynecological conditions. The main goal is to evaluate clinical outcomes, surgical approaches, and complications in real-world clinical practice.",[26,27,28,29,30,31,32,33,34],"Benign Gynecological Disease","Uterine Fibroids","Endometriosis","Adenomyosis","Pelvic Adhesions","Ovarian Cyst Benign","Salpingitis","Polyp Endometrium","Ectopic Pregnancy",[36,37,38,39,40,41,42,43,44,45,46,47,48,49],"Gynecological Surgery","Perioperative Data","Laparoscopy","uterine fibroids","endometriosis","Registry","Uterine Myoma","Pelvic Pain","Surgical Outcomes","Hysteroscopy","Laparotomy","Perioperative Care","Postoperative Complications","Real-World Evidence","NOT_YET_RECRUITING","2026-08-17",{"date":53,"type":54},"2026-08-19","ACTUAL",{"date":56,"type":21},"2026-09",{"date":58,"type":21},"2039-09",{"name":60,"class":61},"IRCCS San Raffaele","OTHER",1,{"id":64,"slug":65,"hasResults":11,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":69,"eligibilityCriteria":70,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":71,"targetDuration":4,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":82,"overallStatus":97,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":107},"100649200","deep-neuromuscular-blockade-and-a-low-residue-diet-for-the-surgical-field-in-vnotes-hysterectomy-100649200","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.",{"count":72,"type":21},160,"INTERVENTIONAL",[75],"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.",[78,26,79,80,81],"Leiomyoma, Uterine","Abnormal Uterine Bleeding (AUB)","Uterine Prolapse","Adenomyosis of Uterus",[83,84,85,86,87,88,89,90,91,92,93,94,95,96],"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","RECRUITING","2026-07-29",{"date":100,"type":54},"2026-07-30",{"date":102,"type":54},"2026-07-01",{"date":104,"type":21},"2027-09-01",{"name":106,"class":61},"Fatih Sultan Mehmet Training and Research Hospital",3]