An interventional study of vNOTES adnexal surgery in Ovarian Cysts, Laparoscopic Gynecologic Surgery and vNOTES, sponsored by Region Skane. Not yet recruiting. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-09.
Sponsored by Region Skane · Not applicable, Interventional, and Treatment
The aim with the study is to compare postoperative pain after vNOTES adnexal surgery versus laparoscopic adnexal surgery.
Women aged 18 and above with an indication for adnexal surgery for benign gynecological pathology or prophylactic reasons will be able to participate.
After surgery the participants will answer a questioner, twice a day in seven days, about postoperative pain and how many units of analgesics they used.
Adnexal 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.
A 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.
80 studies on the registry are indexed under Ovarian Cysts; 16 are open to participants now.
This study's planned enrollment of 200 is above the median of 74 across 51 interventional studies indexed under Ovarian Cysts.
Browse Ovarian Cysts studies →Region Skane is the lead sponsor of 386 studies on the registry; 122 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Procedure: vNOTES adnexal surgery
New minimalinvasive technique
Pain postoperatively by a VAS-scale
To compare postoperative pain after adnexal surgery performed by vNOTES or laparoscopy
Time frame: 7 days postoperative
Painkillers used (amount)
Units of non-opioid analgesics Units of postoperative opioids
Time frame: 7 days postoperatively
Perioperatively complications
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.
Time frame: Perioperatively
Operation time
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.
Time frame: Perioperatively
Postoperative complications
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.
Time frame: 6 weeks postoperatively
Readmission
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.
Time frame: 6 weeks after surgery
Conversion rate
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
Time frame: Perioperatively
Surgeon's experience
Surgeon's experience of comfort and flow measured by a 0 to 10 mm VAS scale
Time frame: Perioperatively
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
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