[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"vaginal-hysterectomy\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:vaginal-hysterectomy":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,52],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":32,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":51},"100609365","phase-4-paracervical-injection-and-opioid-use-after-vaginal-hysterectomy-for-prolapse-100609365",false,"NCT07213635","Paracervical Injection and Opioid Use After Vaginal Hysterectomy for Prolapse","Effect of Paracervical Block on Postoperative Opioid Use in Vaginal Hysterectomy for Prolapse: a Randomized, Placebo-Controlled Trial","Inclusion Criteria:\n\n* Individuals undergoing vaginal hysterectomy with concomitant prolapse repair procedure\n\nExclusion Criteria:\n\n* Non-English speaking\n* Weight less than 50 kg\n* Allergy to bupivacaine\n* Pregnant",true,"FEMALE","18 Years",{"count":20,"type":21},56,"ESTIMATED","INTERVENTIONAL",[24],"PHASE4","The goal of the study to see if giving a numbing medicine around the cervix (called a paracervical block) during vaginal hysterectomy with prolapse repair helps people feel less pain and need fewer strong pain medicines afterward.\n\nThe main question it aims to answer is:\n\n• Does receiving a paracervical block at the time of vaginal hysterectomy with prolapse repair reduce postoperative opioid use?\n\nResearchers will compare opioid use in participants who receive the an injected numbing medicine (bupivacaine with lidocaine) to those that receive a saltwater liquid placebo.\n\nParticipants will:\n\n* Receive either an injection of the numbing medicine (bupivacaine with lidocaine) or saltwater liquid placebo after they are asleep but before any other parts of the surgery are done\n* Record and report pain medications used for 7 days after surgery\n* Report pain scores before discharge from the post anesthesia recovery area on day of surgery as well as 1 and 7 days after surgery\n* Complete a surgical recovery questionnaire during 6 week postoperative visit\n* Complete a one page multiple-choice test on pelvic organ prolapse",[27,28,29,30,31],"Opioid Use","Surgical Recovery","Vaginal Hysterectomy","Prolapse Pelvic","Postoperative Pain",[33,34,35,36,37,38],"paracervical block","vaginal hysterectomy","prolapse repair","postoperative opioid use","postoperative pain scores","postoperative recovery","RECRUITING","2025-10-22",{"date":42,"type":43},"2025-10-24","ACTUAL",{"date":45,"type":43},"2025-10-20",{"date":47,"type":21},"2026-12",{"name":49,"class":50},"University of North Carolina, Chapel Hill","OTHER",1,{"id":53,"slug":54,"hasResults":11,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":58,"eligibilityCriteria":59,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":60,"targetDuration":4,"studyType":22,"phases":62,"briefSummary":64,"conditions":65,"keywords":68,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":5},"100430570","vaginal-notes-hysterectomy-versus-vaginal-hysterectomy-100430570","NCT04886791","Vaginal NOTES Hysterectomy Versus Vaginal Hysterectomy","Vaginal Hysterectomy Versus Vaginal Assisted NOTES Hysterectomy (VANH): a Randomised Controlled Trial","VANH","Inclusion Criteria:\n\n* Written and orally given informed consent\n* 18 years and older\n* Native Dutch speaker or in control of the Dutch language in speaking and writing\n* Indication for hysterectomy for benign indication\n* Possible to perform a VH judged by experienced (resident) gynaecologist during gynaecological examination\n\nExclusion Criteria:\n\n* Any contra-indication for VH (for example, large uterus myomatosus, not enough descensus, etc) as judged by experienced gynaecologist\n* History of more than 1 caesarean section\n* History of endometriosis\n* History of rectal surgery\n* History of pelvic radiation\n* Suspected rectovaginal endometriosis\n* History of pelvic inflammatory disease, especially prior tubo-ovarian or pouch of Douglas abscess or suspected adhesions due to (ruptured) inflammatory disease (for example ruptured appendicitis)\n* Virginity\n* Pregnancy\n* Indication for anterior or posterior colporrhaphy during the same surgery\n* Indication of mid urethral slings\n* Uterus myomatosus will not be an exclusion criteria but the surgeon will indicate if it is possible to remove the uterus vaginally.",{"count":61,"type":21},124,[63],"NA","Rationale: Natural orifice transluminal endoscopic surgery (NOTES) is a minimal invasive technique using the natural body orifices like stomach, oesophagus, bladder, rectum and vagina to access the human body for surgery. In 2012, the first vaginal NOTES (vNOTES) hysterectomy was performed. Potential benefits of vNOTES hysterectomy, also called the vaginal assisted NOTES hysterectomy (VANH) are no visible scars, less pain and a shorter hospital stay compared with laparoscopic hysterectomy as shown in the HALON trial. Up to now, no studies have compared the vNOTES hysterectomy with vaginal hysterectomy.\n\nObjective: The aim of this study is to compare the vNOTES hysterectomy with the vaginal hysterectomy for same day-discharge (SDD), complications, treatment related outcomes, post-operative recovery, quality of life and cost-effectiveness.\n\nStudy design: The study concerns a single-blinded, multicentre, randomised controlled trial.\n\nStudy population: Eligible women who fulfill the inclusion criteria and will undergo a hysterectomy for benign indication.\n\nIntervention: The study population will be randomly allocated to the VANH-group, who undergo a vaginal assisted NOTES hysterectomy (intervention group) or the vaginal hysterectomy group (control-group) and the participants will be single blinded. The pre- and postoperative care will be the same for both groups.\n\nMain study parameters\u002Fendpoints: Primary outcome is the percentage of patients that underwent the hysterectomy as in SDD setting. A total of 41 patients should be included in the control group and a total of 83 patients in the intervention group, using an enrollment ratio of 1:2, with an alpha of 0.05 and a power of 0.8.\n\nThe secondary outcomes are complications, treatment related outcomes, post-operative recovery, quality of life and cost-effectiveness.\n\nNature and extent of the burden and risks associated with participation, benefit and group relatedness:\n\nvNOTES is a new surgical technique, but a combination of two existing techniques namely the vaginal hysterectomy and the laparoscopic hysterectomy. Only one randomized controlled trial has been published, comparing the total laparoscopic hysterectomy (TLH) with the VANH, which shows no inferiority of the vNOTES technique compared to a laparoscopy. A recent case series study has been published about the complication rate in VANH. There was a total complication rate in the hysterectomy group of 5.2%, in which 1.4% was intra-operative and 3.8% postoperative. Theoretically it is possible that the VANH causes less intra-operative complications because of an improved view during the procedure. No further literature is known about VH versus VANH. Participants of the study should fill in multiple questionnaires before randomization and postoperative about their general health, pain experience and used analgesics.",[66,67,29],"Hysterectomy","Natural Orifice Transluminal Endoscopic Surgery",[69,70,58,71,66],"NOTES surgery","vNOTES","Vaginal hysterectomy","2025-08-13",{"date":74,"type":43},"2025-08-14",{"date":76,"type":43},"2021-07-05",{"date":78,"type":21},"2025-12-31",{"name":80,"class":50},"Zuyderland Medisch Centrum"]