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NCT Number: NCT06964594

A Randomized Controlled Trial Study Comparing Adnexal Surgery by vNOTES or Laparoscopy

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.

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Key information

Conditions

Ovarian Cysts Adnexal Diseases Cysts Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Laparoscopic Gynecologic Surgery Neoplasms Ovarian Diseases Urogenital Diseases vNOTES

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participant is willing and able to give informed consent for participation in the trial.
  • Female aged 18 years or above.
  • Diagnosed with adnexal pathology or subject for prophylactic BSO.

Exclusion criteria

  • Female participant who is pregnant or planning pregnancy during course of the trial.
  • Scheduled elective surgery or other procedures requiring general anaesthesia during the trial.
  • 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.
  • Patients taking opioids or other painkillers routinely pre-operatively.
  • Patients with chronic pelvic pain.
  • 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.
  • Failure to provide written informed consent prior to surgery

Treatment and study plan

vNOTES adnexal surgery

Procedure

New minimalinvasive technique

Primary outcomes

  1. Pain postoperatively by a VAS-scale

    Time frame: 7 days postoperative

    To compare postoperative pain after adnexal surgery performed by vNOTES or laparoscopy

Secondary outcomes

  1. Painkillers used (amount)

    Time frame: 7 days postoperatively

    Units of non-opioid analgesics Units of postoperative opioids

  2. Perioperatively complications

    Time frame: Perioperatively

    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.

  3. Operation time

    Time frame: Perioperatively

    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.

  4. Postoperative complications

    Time frame: 6 weeks postoperatively

    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.

  5. Readmission

    Time frame: 6 weeks after surgery

    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.

  6. Conversion rate

    Time frame: Perioperatively

    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

  7. Surgeon's experience

    Time frame: Perioperatively

    Surgeon's experience of comfort and flow measured by a 0 to 10 mm VAS scale

Study contacts

Contact information is provided by the study sponsor or research team.

Andrea E Stuart, M.D Associate Professor

CONTACT

[email protected]

0046736400760

Sponsors and collaborators

Lead sponsor

Region Skane

Other

Registry information

Acronym: ADNOLA

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
May 9, 2025
Registry last updated
May 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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