Efficacy of Ovarian Drilling Via vNOTES Laparoscopy in Patients With PCOS (DRINOTES)

Ovarian drilling procedure by abdominal laparoscopy

1st stage of surgery Patient in gynecological position, double skin cleansing with alcoholic Betadine and vaginal cleansing with dermal Betadine, placement of sterile drapes.

Urinary evacuation catheterization. Introduction of a diagnostic hysteroscope via vaginoscopy. Progress through the cervical canal. Exploration of the uterine cavity. Cannulation using a manipulator to perform a tubal blue test. 2nd stage of surgery: Patient in supine position, legs slightly abducted and semi-flexed. Insufflation of pneumoperitoneum in left hypochondrium with Palmer needle after satisfactory syringe safety test, up to a pressure of 20 mmHg. Trans-umbilical coeliotomy allowing passage of a 10 mm optical trocar after infiltration of the tract with Naropein 7.5 mg/ml.

Placement of two 5 mm operating trocars in the left iliac fossa and suprapubic area after infiltration of the tracts with Naropein 7.5 mg/ml.

Single-stitch closure with Filapeau 3/0.

Ovarian drilling procedure by abdominal laparoscopy versus ovarian drilling procedure by laparoscopic Vnotes .

see each arm for details for each intervention

Patient in gynecological position, double scrubbing of skin with alcoholic Betadine and vaginal with dermal Betadine, sterile drapes in place Urinary evacuation catheterization Introduction of a diagnostic hysteroscope via vaginoscopy Progress through the cervical canal Exploration of the uterine cavity Para-cervical block, uterine cannulation using a manipulator or a pediatric foley probe to perform a tubal blue test.

Placement of a Pozzi on the posterior lip of the cervix. Vaginal incision 1 cm below the cervix for 2 cm, opening the peritoneum with scissors vNOTES Gelpoint device inserted Trendelenburg position Insufflation of pneumoperitoneum(8 mm Hg) Exploration of abdominal cavity Bilateral ovarian drilling; approx. 12 to 15 micro-perforations on each side using the bipolar Versapoint inserted in the Bettochi and regular saline instillation Systematic tubal blue test Removal of the device Exsufflation of pneumoperitoneum Closure of the cul de sac of Douglas with a MONOCRYL 2/0

Ovarian drilling by vaginal laparoscopy VNotes

The resumption (or not) of an ovulatory cycle will be evaluated during the 6 months follow-up visit after the intervention. The resumption of cycles is defined by cycles lasting more than 3 months, an elevated progesterone level, or the presence of a corpus luteum on ultrasound."

For each arm: Pain assessment using a VAS (Visual Analog Scale) requested from the patient in the recovery room at 1 hour during ambulatory care. The scale ranges from 0 to 10, where 0 represents no pain and 10 represents the worst pain imaginable

For each arm: Pain assessment using a VAS (Visual Analog Scale) requested from the patient in the recovery room at 6 hours during ambulatory care. The scale ranges from 0 to 10, where 0 represents no pain and 10 represents the worst pain imaginable

For each arm: Pain assessment using a VAS (Visual Analog Scale) requested from the patient through a questionnaire sent to the patients on Day 1 after the intervention. The scale ranges from 0 to 10, where 0 represents no pain and 10 represents the worst pain imaginable

For each arm: Pain assessment using a VAS (Visual Analog Scale) requested from the patient on Day 7 after the intervention. The scale ranges from 0 to 10, where 0 represents no pain and 10 represents the worst pain imaginable

For each arm: Pain assessment using a VAS (Visual Analog Scale) requested from the patient during the postoperative follow-up visit. The scale ranges from 0 to 10, where 0 represents no pain and 10 represents the worst pain imaginable

For each arm: The use of analgesics (yes/no) recorded up to 2 hours postoperatively

For each arm: The use of analgesics (yes/no) recorded up to 24 hours postoperatively

For each arm: The use of analgesics (yes/no) recorded postoperatively through a questionnaire sent to the patients on Day 1.

For each arm: The use of analgesics (yes/no) recorded postoperatively through a questionnaire sent to the patients on day 7

For each arm: The use of analgesics (yes/no) recorded at the postoperative follow-up visit (1 month)

For each arm: The operative duration from incision to closure recorded in the operating room, as well as the operative duration from the introduction of the Palmer needle in laparoscopy and the vaginal incision in VNotes until closure

for each arm: Rehospitalization due to complications from the operation within the month following the procedure (yes/no), at the postoperative follow-up visit (1 month)

For each arm: Extension of the initial sick leave (yes/no), assessed at the postoperative follow-up visit (1 month)

for each arm: The presence of intraoperative complications recorded during the intervention according to the Clavien-Dindo classification, including whether a conversion occurred, and the number of such complications

For each arm: The use of an extension of the ambulatory stay (yes/no) and the total duration of hospitalization in days and hours

The occurrence of a spontaneous pregnancy, IVF, twin pregnancy, or OHSS if IVF, assessed one year after the 6 months follow-up visit

The measurement of AMH in nanograms/mL at the preoperative visit (1 month before the intervention)

The measurement of AMH in nanograms/mL at the postoperative follow-up visit (1month).

The measurement of AMH in nanograms/mL at the Month 6 follow-up visit

Satisfaction assessment through the SF-36 questionnaire at the postoperative follow-up visit

Satisfaction assessment through the SF-36 questionnaire at the 6 Months follow-up visit