[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"adnexal-diseases\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:adnexal-diseases":34},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,55,87],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":35,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":44,"startDateStruct":47,"completionDateStruct":49,"leadSponsor":51,"locationsCount":54},"100644230","phase-4-cyclobenzaprine-for-postoperative-pain-in-minimally-invasive-hysterectomy-100644230",false,"NCT07664956","Cyclobenzaprine for Postoperative Pain in Minimally Invasive Hysterectomy","Cyclobenzaprine for Postoperative Pain in Minimally Invasive Hysterectomy: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Age \\>18yo\n* Female\n* English speaking\n* Undergoing (robotic assisted or classic) total laparoscopic hysterectomy ± unilateral or bilateral salpingectomy ± unilateral or bilateral oophorectomy\n* If other procedures such as lysis of adhesions, excision of endometriosis, or ureterolysis are indicated based on intraoperative evaluation, those patients may still be included\n* Surgery took place at ChristianaCare Hospitals\n* No allergies or contraindications to standard of care post operative pain medications (acetaminophen, NSAIDs, narcotics) or cyclobenzaprine\n\nExclusion Criteria:\n\n* Age \\\u003C18yo\n* Male\n* Pregnant, breastfeeding\n* Non-English speaking\n* Primary procedures other than laparoscopic hysterectomy\n* Laparoscopic myomectomy\n* Laparoscopic resection of endometriosis\n* Laparoscopic unilateral or bilateral salpingectomy ± unilateral or bilateral oophorectomy ± unilateral or bilateral cystectomy without hysterectomy\n* Hysteroscopic procedures\n* Bartholin gland marsupialization\n* Operations that are scheduled as or converted to the open approach\n* Procedures with planned or unplanned bladder or bowel surgery\n* Allergies or contraindications to standard post operative pain control medications (acetaminophen, NSAIDs, narcotics), such as kidney or liver damage\u002Ffailure, bariatric surgery, history of gastric ulcer, etc.\n* Chronic pain issues, whether self-diagnosed or by a physician, currently undergoing management\n* Currently undergoing medication assisted treatment for opioid use disorder\n* Currently using opioids consistently\n* Allergies or contraindications to cyclobenzaprine:\n* Absolute: use of MAO inhibitors within 14 days, recent heart attack, congestive heart failure, heart block or other conduction abnormalities, cardiac arrhythmias, hyperthyroidism, history of serotonin syndrome\n* Allergies or contraindications to inactive ingredients in Flexeril, such as lactose\n* Patient's receiving gabapentin at baseline or postoperatively, due to potential sedating effects, or other sedating drugs such as scheduled benzodiazepines and barbiturates","FEMALE","18 Years",{"count":19,"type":20},36,"ESTIMATED","INTERVENTIONAL",[23],"PHASE4","Typical postoperative pain control after minimally invasive hysterectomy includes ibuprofen, acetaminophen, and a short course of narcotics. The purpose of this study is to see if adding cyclobenzaprine to this regime improves pain control and lessens narcotic use.",[26,27,28,29,30,31,32,33,34],"Minimally Invasive Surgical Procedures","Abnormal Uterine Bleeding, Unspecified","Adenomyosis of Uterus","Fibroid Uterus","Chronic Pelvic Pain","Endometriosis","Menorrhagia","Endometritis","Adnexal Diseases",[36,37,38,39,40,41],"cyclobenzaprine","flexeril","hysterectomy","minimally invasive hysterectomy","pain control","multimodal pain control","NOT_YET_RECRUITING","2026-06-18",{"date":45,"type":46},"2026-06-24","ACTUAL",{"date":48,"type":20},"2026-07-01",{"date":50,"type":20},"2026-12-01",{"name":52,"class":53},"Christiana Care Health Services","OTHER",1,{"id":56,"slug":57,"hasResults":11,"nctId":58,"briefTitle":59,"officialTitle":59,"acronym":4,"eligibilityCriteria":60,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":61,"enrollmentInfo":62,"targetDuration":4,"studyType":21,"phases":64,"briefSummary":66,"conditions":67,"keywords":74,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":54},"100579755","a-clinical-study-on-the-feasibility-and-safety-of-abdominal-endoscopic-single-port-surgery-system-to-assist-gynecological-day-surgery-100579755","NCT06828419","A Clinical Study on the Feasibility and Safety of Abdominal Endoscopic Single-port Surgery System to Assist Gynecological Day Surgery","Inclusion Criteria:\n\n1. Women aged 18 to 75 years old, with a body mass index (BMI) of no more than 32 kg\u002Fm2;\n2. Conscious, no history of mental illness, accompanied by an adult during the perioperative period;\n3. Educate the subjects, who are willing to undergo day surgery, understand and accept the surgical method and anesthesia method;\n4. Subjects and families understand perioperative care and are willing and able to complete post-discharge care;\n5. Elective surgery, no serious complications affecting the operation and prognosis, aCCI age adjusted comorbidity index 0 points;\n6. According to the adhesion risk scoring system of European Anti-Adhesions in Gynaecology Expert Panel (ANGEL), the adhesion risk was divided into three levels: high, medium and low. Subjects with low risk (0 to 12 points) and abdominal wall scarring and pelvic cavity B-ultrasonography do not indicate obvious pelvic cavity adhesion wiil be included.\n\nExclusion Criteria:\n\n1. Moderate and high-risk patients will be excluded based on ANGEL adhesion risk scoring system;\n2. Subjects with hemorrhagic rupture of ectopic pregnancy and unstable vital signs;\n3. Genital tract infection or in the acute phase of systemic infection;\n4. Subjects on long-term anticoagulant therapy or with coagulation dysfunction;\n5. Subjects have severe heart and lung disease, liver and kidney dysfunction, and cannot tolerate anesthesia;\n6. A history of abdominal or diaphragmatic hernia, abnormal umbilical cord development, or umbilical surgery;\n7. Not willing to undergo endoscopic surgery;\n8. Participated in other drug and device clinical trials within 3 months before surgery.","75 Years",{"count":63,"type":20},63,[65],"NA","In this study, a prospective study is used to select patients who will undergo intra-abdominal endoscopic single-port surgery system for benign gynecological diseases from February 2025 to December 2026 in the Second Affiliated Hospital of Wenzhou Medical University, including hysterectomy, myomectomy, ovarian cyst removal and adnexectomy. The study will perform statistical analysis to evaluate the feasibility and the main factors affecting the safety of intra-abdominal endoscopic single-port surgery system(SR-ENS-600) used in gynecological day surgery.",[68,69,70,71,72,73,34],"Adenopathy","Uterine Fibroids","Ovarian Cysts","Adnexal Mass","Ovarian Diseases","Adnexal Cyst",[75,76,77],"robotic-assisted laparoscopic single-site surgery (R-LESS)","single-port robot system (SPRS)","day surgery","2025-03-27",{"date":80,"type":46},"2025-04-03",{"date":82,"type":20},"2025-04-10",{"date":84,"type":20},"2026-12-31",{"name":86,"class":53},"Second Affiliated Hospital of Wenzhou Medical University",{"id":88,"slug":89,"hasResults":11,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":4,"eligibilityCriteria":93,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":94,"enrollmentInfo":95,"targetDuration":4,"studyType":21,"phases":97,"briefSummary":98,"conditions":99,"keywords":4,"overallStatus":108,"whyStopped":4,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":54},"100497748","assessment-of-womens-sexual-quality-of-life-after-benign-adnexal-surgery-using-vnotes-approach-100497748","NCT05761275","Assessment of Women's Sexual Quality of Life After Benign Adnexal Surgery Using vNOTES Approach","Assessment of Women's Sexual Quality of Life After Benign Adnexal Surgery Using vNOTES Approach in Comparison to Conventional Laparoscopy: a Randomized Controlled Trial","Inclusion Criteria:\n\n* Women aged from 18 to 70 years\n* Discernment capacity with oral and written consent signed\n* Heterosexual intercourse (with vaginal penetration) within four weeks prior to inclusion in the study\n\nExclusion Criteria:\n\n* History of rectal surgery.\n* Suspected rectovaginal\u002Fretrocervical endometriosis.\n* History of brachytherapy or pelvic radiation.\n* Suspected malignancy.\n* History of severe pelvic inflammatory disease.\n* Active lower genital tract infection.\n* Pregnancy.\n* Women who do not speak fluent French or English.\n* Patients under tutelage (with or without capacity of judgement).","70 Years",{"count":96,"type":20},62,[65],"Transvaginal Natural Orifice Transluminal Endoscopic Surgery (vNOTES) is a recent innovation in minimally invasive surgery which has already proven its non-inferiority to conventional abdominal laparoscopy (CAL) for hysterectomy in terms of efficiency and safety. However, the investigators note a lack of medical literature and no specific randomized controlled trial (RCT) assessing women's sexual function after vNOTES for benign adnexal surgery.\n\nThe aim of this RCT is to confirm the non-inferiority of the vNOTES approach for benign adnexal pathology compared to CAL on women's sexual function. Secondary outcomes will evaluate vNOTES's efficiency, morbidity and postoperative complications compared to CAL for benign adnexal surgery. The relationship between adnexal mass morcellation\u002Faspiration and the quality of the histological analysis on surgical specimens will also be evaluated as secondary outcome.",[100,71,73,101,34,102,103,104,105,106,107],"Gynecologic Disease","Sexuality","Sexual Dysfunction","Quality of Life","Pathology","Dyspareunia","Pelvic Pain","Complication","RECRUITING","2025-03-24",{"date":78,"type":46},{"date":112,"type":46},"2024-01-01",{"date":114,"type":20},"2027-04-03",{"name":116,"class":53},"Jean Dubuisson"]