[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100487164":3},{"organization":4,"outcomesModule":7,"designInfo":24,"detailedDescription":27,"studyPopulation":28,"armGroups":29,"interventions":35,"overallOfficials":41,"centralContacts":46,"locations":52,"responsibleParty":73,"collaborators":11,"id":76,"slug":77,"hasResults":78,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":82,"eligibilityCriteria":83,"healthyVolunteers":84,"sex":85,"minAge":86,"maxAge":11,"enrollmentInfo":87,"targetDuration":11,"studyType":90,"phases":11,"briefSummary":91,"conditions":92,"keywords":94,"overallStatus":55,"whyStopped":11,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":107},{"fullName":5,"class":6},"The University of Texas Health Science Center, Houston","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":11},[9],{"measure":10,"description":11,"timeFrame":12},"The rate of adhesions\u002Fcomplicated entry to the Douglas space reported during surgery",null,"From recruitment in the clinics until one month post-operation",[14,18,22],{"measure":15,"description":16,"timeFrame":17},"Operative complication rate","Operative complications include organ damage (damage caused during the surgery to the bladder, the rectum or blood vessel), bleeding, and vascular damage.","during the operation",{"measure":19,"description":20,"timeFrame":21},"Post-operative complication rate","Post-operative complications include surgical site infection (SSI), dyspareunia, vaginal bleeding, re-hospitalization, and pain.","from operation until one month post-operation",{"measure":23,"description":11,"timeFrame":17},"Operation time",{"allocation":11,"interventionModel":11,"interventionModelDescription":11,"primaryPurpose":11,"observationalModel":25,"timePerspective":26,"maskingInfo":11},"COHORT","PROSPECTIVE","Vaginal Natural Orifice Transluminal Endoscopic Surgery (vNOTES) is an emerging field in minimally invasive surgery. It has gained the most popularity compared to other transluminal natural orifices such as mouth, rectum or urinary tract. By incorporating the advantages of endoscopic surgery, the vNOTES approach avoids abdominal wall wounds and trocar-related complications. Recent studies report reduced postoperative pain, accelerated postoperative recovery, and decreased postoperative wound infections, as well as achieving highly satisfying cosmetic results. All these made this technique very appealing to surgeons and patients alike.\n\nThe feasibility and safety of vNOTES in gynecologic surgeries was first introduced by Ahn et al. in 2012 that performed vNOTES in ten women with benign uterine adnexal disease. Since then, surgeons have developed the technique in various benign gynecologic surgeries indications. There has been an exponential uptake of the number of surgeons performing vNOTES procedures worldwide with no official guidance to ensure the safe implementation of this technique into gynecological practice. The novelty of the technique is still a matter of concern in sub-populations and different indications.\n\nInternational consensus-based statement was recently published based on Delphi consensus of expert panel to help guide the basis for adopting vNOTES into clinical practice with respect to eight key domains including patient selection. It was agreed that women with potential adhesions are not appropriate candidates for vNOTES approach including women with a history of a severe PID that is considered contraindication. 97.4% of the experts agreed that it is not necessary to perform a preoperative vaginal culture if the patient is asymptomatic. However, as some pelvic infections might be asymptomatic, such as with chlamydia, pre-operation imaging might be beneficial to complete proper patient selection for the vNOTES approach. Moreover, women with previous severe PID infection might still have favorable pelvic characteristics to perform the vNOTES approach.\n\nAim: To the best of our knowledge no guidelines have been published regarding the pre-operation evaluation and the imaging characteristics. Due to the aforementioned, the aim of our study is to compare pre-operation ultrasound evaluation to operative characteristics and outcomes. Douglas space characteristics, as assessed by ultrasound evaluation of sliding sign, of the patients undergoing vNOTES approach surgery will be compared to patients that were ruled from vNOTES approach in order to evaluate the association of the presence or absence of sliding sign on pre-operation ultrasound to the clinical findings.\n\nClinical Procedures:\n\nAs part of the evaluation at the pre-operation clinics, women will complete vaginal examination to assess for pelvic organs mobility and potential adhesions.\n\nTrans-vaginal examination will be completed to evaluate uterus and adnexal characteristics in addition to sliding sign between the uterus to the rectum for the evaluation of the Douglas space.\n\nWomen with normal ultrasound evaluation and a positive sliding sign will continue with surgery via the vNOTES approach. Women with limited mobility demonstrated on ultrasound will be recommended alternative surgical approaches.\n\nSwabs will be collected for potential PID pathogens including chlamydia, gonorrhea, trichomonas and mycoplasma.\n\nThe operation report will include information regarding pelvic adhesions, location of the adhesions and abdominal screening (Including diaphragm and liver area). For patients undergoing vNOTES approach surgery - difficulty to complete anterior or posterior colpotomy will be documented.","Women who are patients at UT Physicians gynecological clinics, are planned to undergo benign gynecological surgery (hysterectomy or adnexectomy) with normal vaginal examination (normal mobility of the uterus), and are considered for the vNOTES surgical approach.",[30],{"label":31,"type":11,"description":32,"interventionNames":33},"Candidates for the vaginal natural orifice trans-luminal surgery (vNOTES) approach","Candidates for benign gynecological surgery in the vaginal natural orifice trans-luminal surgery (vNOTES) approach",[34],"Diagnostic Test: Trans-vaginal ultrasound",[36],{"type":37,"name":38,"description":39,"armGroupLabels":40,"otherNames":11},"DIAGNOSTIC_TEST","Trans-vaginal ultrasound","Pre-operative trans-vaginal ultrasound in order to evaluate sliding sign between the uterus and the rectum for the evaluation of the Douglas space",[31],[42],{"name":43,"affiliation":44,"role":45},"Aya Mohr-Sasson","The University of Texas Health Science Center, Houston, TX","PRINCIPAL_INVESTIGATOR",[47],{"name":48,"role":49,"phone":50,"phoneExt":11,"email":51},"Aya Mohr-Sasson, M.D","CONTACT","13462704682","aya.mohrsasson@uth.tmc.edu",[53],{"facility":54,"status":55,"city":56,"state":57,"zip":58,"country":59,"countryCode":60,"cosmosGeoPoint":61,"geoPoint":66,"contacts":67},"University of Texas","RECRUITING","Houston","Texas","77030","United States","US",{"type":62,"coordinates":63},"Point",[64,65],-95.36327,29.76328,{"lat":65,"lon":64},[68,70],{"name":48,"role":49,"phone":69,"phoneExt":11,"email":51},"346-270-4682",{"name":71,"role":49,"phone":11,"phoneExt":11,"email":72},"Sunbola Ashimi","sunbola.s.ashimi@uth.tmc.edu",{"type":45,"investigatorFullName":74,"investigatorTitle":75,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"Aya Mohr Sasson","Principle investigator","100487164","ultrasound-evaluation-for-improving-patient-selection-in-vnotes-100487164",false,"NCT05623514","Ultrasound Evaluation for Improving Patient Selection in vNOTES","Pre-surgical Ultrasound Evaluation for Improving Patient Selection for vNOTES Approach","PUP-VNOTES","Inclusion criteria:\n\n-Women planned to undergo surgery for hysterectomy or adnexal indication with normal vaginal examination, that are considered for vNOTES approach.\n\nExclusion criteria:\n\n* History of radiation to the pelvis\n* Malignancy\n* Combined current vaginal operation (for the treatment of prolapse\u002F urinary complaints)",true,"FEMALE","18 Years",{"count":88,"type":89},75,"ESTIMATED","OBSERVATIONAL","Vaginal Natural Orifice Transluminal Endoscopic Surgery (vNOTES) is an emerging field in minimally invasive surgery. An international consensus-based statement was recently published to help guide the basis for adopting vNOTES into clinical practice, including regarding patient selection. It was agreed that women with potential adhesions are not appropriate candidates for vNOTES approach including women with suspected adhesions due to history of severe pelvic inflammatory disease (PID) or endometriosis. However, as some pelvic infections might be asymptomatic, pre-operation imaging might be beneficial to complete improved selection of patients. Moreover, women with previous severe PID or endometriosis might still have favorable pelvic characteristics to perform the vNOTES approach. Therefore, we aim to compare pre-operation ultrasound evaluation to operative characteristics and outcomes in women undergoing VNOTES approach surgery. Douglas space characteristics, as assessed by ultrasound evaluation of sliding sign, of the patients undergoing vNOTES approach surgery will be compared to patients that were ruled from vNOTES approach in order to evaluate the association of the presence or absence of sliding sign on pre-operation ultrasound to the clinical findings.",[93],"Surgery",[95,96,97],"vaginal surgery","trans-vaginal ultrasound examination","sliding sign","2026-09-27",{"date":100,"type":101},"2026-10-01","ACTUAL",{"date":103,"type":101},"2022-05-16",{"date":105,"type":89},"2027-12",{"name":5,"class":6},1]