[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"adnexal-cyst\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:adnexal-cyst":25},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,46,80,109,141,173],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":27,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100592042","ultrasound-guided-transvaginal-aspiration-of-cystic-pelvic-lesions-100592042",false,"NCT06988280","Ultrasound-guided Transvaginal Aspiration of Cystic Pelvic Lesions","UTAC","Participants eligible for inclusion in this study must meet all of the following criteria:\n\n1. Lesion criteria applicable for therapeutic intervention\n\n   1. Safe accessibility of the lesion (within reach of aspiration needle; visible on ultrasound; transvaginal access; no interposition of bowel or blood vessels)\n   2. Lesion types included: cystic lesions (adnexal cysts), pelvic inclusion cysts (pseudocysts), pelvic abscesses\n2. Indications\n\n   1. Pain relief in symptomatic cystic lesions with benign appearance.\n   2. Symptomatic treatment in probably malignant lesions (only in non-curative setting).\n\nExclusion Criteria:\n\n1. Patients \\\u003C18 years\n2. Poor performance status contra-indicating the procedure\n3. Vaginal stenosis (severe atrophy - virgo - vaginismus)\n4. Purely solid lesions\n5. Cystic lesions with a presumed malignant diagnosis and a risk of tumor dissemination in a curative setting\n6. Physiological cysts in asymptomatic patients (in case of doubt the patient is reassessed after 3-6 months)","FEMALE","18 Years",{"count":19,"type":20},100,"ESTIMATED","OBSERVATIONAL","Adnexal cysts or pseudocysts are a common finding on transvaginal ultrasound, especially in premenopausal women. Due to the size of some cysts, they may cause discomfort. Moreover, a genuine risk of ovarian torsion presents when these lesions grow.\n\nDuring the last decades, great advancements have been made in the correct differentiation of benign from malignant lesions. However, there still is controversy concerning the optimal treatment approach of symptomatic adnexal cysts with a low risk of malignancy, consisting of both surgery or ultrasound-guided transvaginal aspiration. Factors such as comorbidities and lesion characteristics need to be considered when counselling patients, as well as the possibility of short term recurrence.\n\nSurgically removing them may result in longer hospital stays and recovery, with higher costs, while transvaginal needle aspiration techniques can be performed during a consultation. Additional benefits in avoiding surgery, particularly in women of reproductive age, are fertility preservation and less pelvic adhesions.\n\nOn the other hand, the main arguments against cyst aspiration are the relatively high recurrence rate of cysts, the minimal risk of malignant cell dissemination (In case of a false negative diagnosis) and the cytological instead of a histopathological examination.\n\nWith this in mind, it is important to base management decisions on the sonographic features of the lesions.\n\nIn addition, cyst aspiration can also be considered in large symptomatic cysts with a high risk of malignancy, but where curative treatment with surgical or chemotherapeutical intervention cannot be considered due to poor general condition of the patient. Especially in the absence of large volume ascites or peritoneal carcinomatosis, but with significant symptoms due to lesion size, cyst aspiration may give short term symptom alleviation. Given the risk of cancer cell dissemination, this intervention is always discussed in a multidisciplinary team discussion, to balance risk and benefits for patients with no other treatment options, Transvaginal needle aspiration is also being used in pelvic abscesses. The study of K. Gjelland et al. found that transvaginal aspiration combined with antibiotic treatment of pelvic abscesses is equally effective as surgically removing them. They state that this should be first-line treatment for abscesses, as it is minimally invasive, leading to better patient tolerance and avoiding the risks associated with anesthesia and surgery.\n\nSaline irrigation of the abscess cavity can be performed, making the process of pus aspiration easier when the consistency is too viscous.\n\nThe literature still lacks studies about the symptom relief in patients receiving treatment for pelvic cystic lesions. Given that this is an important outcome parameter in determining the feasibility of performing procedures, more research in this area is needed.\n\nThe main aim of this prospective study is to evaluate the patient's symptom relief and cyst recurrence rate after ultrasound-guided transvaginal aspiration of pelvic cystic lesions or abscess drainage. Secondly, the safety and the patient's overall experience during as well as immediately after the procedure will be assessed.",[24,25,26],"Pelvic Abscess","Adnexal Cyst","Ovarian Neoplasms",[28,29,30,31,32],"adnexal cyst","transvaginal aspiration","cyst recurrence","pelvic abscess","symptom relief","RECRUITING","2025-05-22",{"date":36,"type":37},"2025-05-23","ACTUAL",{"date":39,"type":37},"2025-03-13",{"date":41,"type":20},"2028-12",{"name":43,"class":44},"Universitaire Ziekenhuizen KU Leuven","OTHER",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":52,"enrollmentInfo":53,"targetDuration":4,"studyType":55,"phases":56,"briefSummary":58,"conditions":59,"keywords":66,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":45},"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":54,"type":20},63,"INTERVENTIONAL",[57],"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.",[60,61,62,63,64,25,65],"Adenopathy","Uterine Fibroids","Ovarian Cysts","Adnexal Mass","Ovarian Diseases","Adnexal Diseases",[67,68,69],"robotic-assisted laparoscopic single-site surgery (R-LESS)","single-port robot system (SPRS)","day surgery","NOT_YET_RECRUITING","2025-03-27",{"date":73,"type":37},"2025-04-03",{"date":75,"type":20},"2025-04-10",{"date":77,"type":20},"2026-12-31",{"name":79,"class":44},"Second Affiliated Hospital of Wenzhou Medical University",{"id":81,"slug":82,"hasResults":11,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":4,"eligibilityCriteria":86,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":87,"enrollmentInfo":88,"targetDuration":4,"studyType":55,"phases":90,"briefSummary":91,"conditions":92,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":45},"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":89,"type":20},62,[57],"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.",[93,63,25,94,65,95,96,97,98,99,100],"Gynecologic Disease","Sexuality","Sexual Dysfunction","Quality of Life","Pathology","Dyspareunia","Pelvic Pain","Complication","2025-03-24",{"date":71,"type":37},{"date":104,"type":37},"2024-01-01",{"date":106,"type":20},"2027-04-03",{"name":108,"class":44},"Jean Dubuisson",{"id":110,"slug":111,"hasResults":11,"nctId":112,"briefTitle":113,"officialTitle":114,"acronym":115,"eligibilityCriteria":116,"healthyVolunteers":117,"sex":16,"minAge":118,"maxAge":119,"enrollmentInfo":120,"targetDuration":122,"studyType":21,"phases":4,"briefSummary":123,"conditions":124,"keywords":127,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":133,"lastUpdatePostDateStruct":134,"startDateStruct":136,"completionDateStruct":138,"leadSponsor":140,"locationsCount":45},"100569388","masses-in-young-patients---international-ovarian-tumour-analysis-my-iota-100569388","NCT06693596","Masses in Young Patients - International Ovarian Tumour Analysis (MY-IOTA)","Masses in Young Patients - International Ovarian Tumour Analysis: Prospective Validation and Comparison of Simple Rules, Benign Descriptors and ADNEX Models for Discrimination Between Benign and Malignant Adnexal Masses in Young Girls and Adolescents MY-IOTA","MY-IOTA","• Inclusion Criteria:\n\nAll newly diagnosed adnexal masses identified in a girl or adolescent aged 20 or under.\n\n• Exclusion Criteria:\n\nParticipants eligible for this study must not meet any of the following criteria:\n\n* Non-adnexal masses e.g. peritoneal inclusion cysts (where diagnosis is certain) and peritoneal carcinomatosis with no adnexal mass;\n* The denial or withdrawal of written informed consent.\n* Pregnancy at any timepoint during the study period\n* In premenarchal participants: follicle measuring \\\u003C10mm",true,"0 Years","20 Years",{"count":121,"type":20},1000,"2 Years","This multicenter observational study aims to validate the IOTA Simple Rules, Benign Descriptors, and ADNEX model in a cohort of patients equal or under the age of 20. Moreover, the study aims to evaluate the diagnostic accuracy of subjective assessment by ultrasound and to analyze the rate of complications in patients treated conservatively.",[63,125,25,126],"Adnexal Tumor","Adnexal Masses in Young Girls and Adolescents",[128,129,130,131,132],"IOTA","ovarian mass","benign","malignant","Young patients","2024-11-14",{"date":135,"type":37},"2024-11-18",{"date":137,"type":20},"2024-11-20",{"date":139,"type":20},"2026-09-30",{"name":43,"class":44},{"id":142,"slug":143,"hasResults":11,"nctId":144,"briefTitle":145,"officialTitle":146,"acronym":147,"eligibilityCriteria":148,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":149,"enrollmentInfo":150,"targetDuration":4,"studyType":55,"phases":152,"briefSummary":153,"conditions":154,"keywords":160,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":164,"lastUpdatePostDateStruct":165,"startDateStruct":167,"completionDateStruct":169,"leadSponsor":171,"locationsCount":45},"100565162","mirrors-frozen---comparing-open-vs-robotic-surgery-in-the-management-of-women-with-complex-pelvic-adnexal-masses--8cm-100565162","NCT06638593","MIRRORS-FROZEN - Comparing Open Vs Robotic Surgery in the Management of Women with Complex Pelvic Adnexal Masses ≤ 8cm.","MIRRORS-FROZEN - a Pilot Randomised Controlled Trial (RCT) Comparing Open Vs Robotic Surgery in the Management of Women with Complex Pelvic Adnexal Masses ≤ 8cm.","MIRRORS-FROZEN","Inclusion Criteria:\n\n* Complex adnexal Pelvic mass\u002Fes ≤8 cm with no malignant disease outside the adnexae on CT or MRI.\n* Women aged ≥18 \\& ≤100 years old.\n* Patients who had given their signed and written informed consent\n\nExclusion Criteria:\n\n* Adnexal pelvic mass \\> 8 cm.\n* Radiological or histological or cytological evidence of stage III or IV disease.\n* Lack of capacity to understand and give informed consent.\n* Patients not suitable for laparoscopic surgery, such as but not limited to those with severe aortic stenosis.\n* Any patient randomized to either of the study arms and found to have disease which appears greater than stage 1 will be withdrawn from the trial and treated according to the national guidelines","100 Years",{"count":151,"type":20},40,[57],"Adnexal masses are growths that can form in the ovaries or fallopian tubes for different reasons, such as hormonal changes, infection, or cancer. These masses may cause pelvic discomfort, pain, constipation, or no symptoms at all. When adnexal masses are found on scans, they are described in a certain way to indicate if they could represent early-stage cancer, and the word \"complex\" is used to refer to these masses. Surgery is often recommended, where the mass is removed and examined under the microscope during surgery in a process called (frozen section analysis); to determine its true nature.\n\nIt is still difficult to confirm cancer before surgery, and many of these masses turn out to be benign (not cancerous) or borderline (slow-growing tumours). Currently, doctors use open surgery with a cut from at least the belly button to the pubic bone to remove these masses. Patients with a cancer diagnosis will then have more surgical steps including assessment and sampling of various areas inside the abdomen (known as staging surgery) to see how far the cancer has spread.\n\nRecovery after open surgery can be long and painful, with a slow return to normal daily activities. The trial investigators know from practice that robotic surgery has replaced open surgery for most benign adnexal diseases and other types of women's cancers, such as womb cancer. Recovery is quicker, with less pain and blood loss, allowing for a faster return to daily activities.\n\nThis study, MIRRORS-FROZEN (pilot), compares robotic versus the standard open surgery in managing women with complex adnexal masses of eight centimetres or less. The hope is to decrease the need for open surgery in patients with benign or borderline disease and to assess if robotic surgery has similar, worse, or better outcomes for patients with cancer.\n\nMIRRORS-FROZEN is funded by Intuitive Foundation and GRACE Charity. The investigators will establish the feasibility of conducting a large multicentre randomized controlled trial in the future comparing certain cancer outcomes between robotic and open surgery.",[155,156,62,157,158,25,159],"Ovarian Cancer","Ovarian Mass","Fallopian Tube Neoplasms","Adnexal Carcinoma","Adnexal Masses",[161,162,163],"Robotic","adnexal masses","Adnexal cysts","2024-10-10",{"date":166,"type":37},"2024-10-15",{"date":168,"type":37},"2024-09-23",{"date":170,"type":20},"2027-02-01",{"name":172,"class":44},"Royal Surrey County Hospital NHS Foundation Trust",{"id":174,"slug":175,"hasResults":11,"nctId":176,"briefTitle":177,"officialTitle":178,"acronym":179,"eligibilityCriteria":180,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":181,"enrollmentInfo":182,"targetDuration":183,"studyType":21,"phases":4,"briefSummary":184,"conditions":185,"keywords":187,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":191,"lastUpdatePostDateStruct":192,"startDateStruct":194,"completionDateStruct":196,"leadSponsor":198,"locationsCount":45},"100514140","prospective-validation-of-the-adnex-model-for-discrimination-between-benign-and-malignant-adnexal-masses-in-pregnancy-international-ovarian-tumour-analysis-in-pregnancy-study-p-iota-100514140","NCT05974618","Prospective Validation of the ADNEX Model for Discrimination Between Benign and Malignant Adnexal Masses in Pregnancy: International Ovarian Tumour Analysis in Pregnancy Study (p-IOTA)","Prospective Validation of the ADNEX Model for Discrimination Between Benign and Malignant Adnexal Masses in Pregnancy: the International Ovarian Tumour Analysis in Pregnancy Study (p-IOTA).","pIOTA","Inclusion Criteria:\n\n* • Consecutive patients with non-physiological adnexal masses or physiological cysts measuring 5cm or more in largest dimension;\n\n  * In case of more than one mass seen, only most suspicious mass to be included OR in case of two similar masses, the one with the largest dimension or most easily accessible with ultrasound;\n  * Previously recruited patient presenting with a different mass in subsequent pregnancy;\n  * Age 18 years and above.\n\nExclusion Criteria:\n\n* • Cysts deemed to be clearly physiological WHEN smaller than 5 cm (largest diameter);\n\n  * Non-adnexal masses, e.g. peritoneal inclusion cysts (when diagnosis is certain) and peritoneal carcinomatosis with no adnexal mass;\n  * The denial or withdrawal of written informed consent;\n  * Same cyst already recruited for p-IOTA in a previous pregnancy.\n  * Age \\\u003C 18 years","50 Years",{"count":121,"type":20},"1 Year","Prospective Validation of the ADNEX Model for discrimination between benign and malignant adnexal masses in pregnancy:\n\nInternational Ovarian Tumour Analysis in pregnancy study (p-IOTA)",[63,125,25,186],"Pregnancy Related",[128,129,188,189,190,130,131],"pregnancy","ultrasound","post-partum","2023-07-25",{"date":193,"type":37},"2023-08-03",{"date":195,"type":37},"2023-06-05",{"date":197,"type":20},"2026-07",{"name":43,"class":44}]