Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2025-12-27 @ 11:01 PM
Study NCT ID:
NCT06964594
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-05-09
First Post:
2025-05-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Randomized Controlled Trial Study Comparing Adnexal Surgery by vNOTES or Laparoscopy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010048', 'term': 'Ovarian Cysts'}], 'ancestors': [{'id': 'D003560', 'term': 'Cysts'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Pragmatic multicentre two-armed superiority randomized controlled trail. No blinding.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2028-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-01', 'studyFirstSubmitDate': '2025-05-01', 'studyFirstSubmitQcDate': '2025-05-01', 'lastUpdatePostDateStruct': {'date': '2025-05-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain postoperatively by a VAS-scale', 'timeFrame': '7 days postoperative', 'description': 'To compare postoperative pain after adnexal surgery performed by vNOTES or laparoscopy'}], 'secondaryOutcomes': [{'measure': 'Painkillers used (amount)', 'timeFrame': '7 days postoperatively', 'description': 'Units of non-opioid analgesics Units of postoperative opioids'}, {'measure': 'Perioperatively complications', 'timeFrame': 'Perioperatively', 'description': 'The incidence of intra-operative complications, i.e. any adverse event before the end of the surgical intervention including injury to the bladder, ureter, bowel, or intrapelvic/intra-abdominal vessels, as a dichotomous outcome.'}, {'measure': 'Operation time', 'timeFrame': 'Perioperatively', 'description': 'Operation time, measured as the time in minutes from the insertion of the bladder catheter to the end of vaginal/abdominal wound closure, as a continuous outcome.'}, {'measure': 'Postoperative complications', 'timeFrame': '6 weeks postoperatively', 'description': 'Postoperative complications: major bleeding or pelvic hematoma requiring transfusion. Infections of the vaginal incision, abdominal wall or wound, urinary tract, chest, or febrile episodes/unspecified infections. Thromboembolism. Postoperative ileus or wound dehiscence. Classified according to the Clavien- Dindo, classification as a dichotomous outcome.'}, {'measure': 'Readmission', 'timeFrame': '6 weeks after surgery', 'description': 'The rates of readmission requiring hospitalization for at least 24 hours for any adverse event causally related to the gynaecological intervention during the first six weeks after surgery, as a dichotomous outcome.'}, {'measure': 'Conversion rate', 'timeFrame': 'Perioperatively', 'description': 'Conversion rates: the proportion of women treated by any other approach than the allocated technique as randomized, as a dichotomous outcome. vNOTES will most likely be converted to LSC and LSC to open surgery'}, {'measure': "Surgeon's experience", 'timeFrame': 'Perioperatively', 'description': "Surgeon's experience of comfort and flow measured by a 0 to 10 mm VAS scale"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ADNOLA - A randomized controlled trial study comparing adnexal surgery by vNOTES or laparoscopy'], 'conditions': ['Ovarian Cysts', 'Laparoscopic Gynecologic Surgery', 'vNOTES']}, 'descriptionModule': {'briefSummary': 'The aim with the study is to compare postoperative pain after vNOTES adnexal surgery versus laparoscopic adnexal surgery.\n\nWomen aged 18 and above with an indication for adnexal surgery for benign gynecological pathology or prophylactic reasons will be able to participate.\n\nAfter surgery the participants will answer a questioner, twice a day in seven days, about postoperative pain and how many units of analgesics they used.\n\nAdnexal surgery is one of the most common surgical procedures performed in women and can either be performed to treat pathology as ovarian cysts or prophylactically in case of hereditary genetic alterations.\n\nA laparoscopic technique is currently considered as gold standard for adnexal procedures. The latest advancement in minimally invasive surgery is vNOTES (vaginal natural orifice transluminal endoscopy), in which the entrance to the abdomen is performed by an anterior or more commonly posterior colpotomy rather than via the abdominal wall. The NOTABLE trial was a RCT showing that vNOTES adnexectomy was non-inferior to laparoscopy for successful removal of benign adnexa without conversion (Baekelandt). vNOTES adnexectomy had shorter surgical time, less use of analgesics and lower self-assessed VAS scores the first week post-operatively. The aim with our study is to compare postoperative pain after vNOTES versus laparoscopic adnexal surgery.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Participant is willing and able to give informed consent for participation in the trial.\n* Female aged 18 years or above.\n* Diagnosed with adnexal pathology or subject for prophylactic BSO.\n\nExclusion Criteria:\n\n* Female participant who is pregnant or planning pregnancy during course of the trial.\n* Scheduled elective surgery or other procedures requiring general anaesthesia during the trial.\n* Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participant at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial.\n* Patients taking opioids or other painkillers routinely pre-operatively.\n* Patients with chronic pelvic pain.\n* Patients with surgical contraindication; previous hysterectomy, history of rectal surgery, suspected or confirmed endometriosis, suspected malignancy, suspected obliteration of the pouch of Douglas following severe PID or other causes, active lower genital tract infection, pregnancy.\n* Failure to provide written informed consent prior to surgery"}, 'identificationModule': {'nctId': 'NCT06964594', 'acronym': 'ADNOLA', 'briefTitle': 'A Randomized Controlled Trial Study Comparing Adnexal Surgery by vNOTES or Laparoscopy', 'organization': {'class': 'OTHER', 'fullName': 'Region Skane'}, 'officialTitle': 'A Randomized Controlled Trial Study Comparing Adnexal Surgery by vNOTES or Laparoscopy', 'orgStudyIdInfo': {'id': '2025-00965-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Laparoscopic Adnexal surgery', 'interventionNames': ['Procedure: vNOTES adnexal surgery']}], 'interventions': [{'name': 'vNOTES adnexal surgery', 'type': 'PROCEDURE', 'description': 'New minimalinvasive technique', 'armGroupLabels': ['Laparoscopic Adnexal surgery']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Andrea E Stuart, M.D Associate Professor', 'role': 'CONTACT', 'email': 'andrea.stuart@skane.se', 'phone': '0046736400760'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Region Skane', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Andrea Stuart', 'investigatorAffiliation': 'Region Skane'}}}}