TerminatedNot Applicable

vNOTES Salpingo-oophorectomy or Bilateral Salpingectomy Compared With Laparoscopic.

Stopped: low enrollment rate

Israel1 participantsStarted 2022-05-29

Plain-language summary

Objective: To compare the vNOTES approach versus conventional laparoscopic approach used in elective Salpingo-oophorectomy surgery for benign disease or bilateral salpingectomy for sterilization. Study design: Prospective cohort, randomized controlled trial. Study population: Planned Salpingo-oophorectomy for benign disease or bilateral salpingectomy for sterilization. Primary outcome - Adherence to planned surgical route, intra-operative parameters \& complications, post-operative parameters \& complications, rate of satisfaction.

Who can participate

Age range18 Years – 80 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Women aged between 18 and 80 years.
✓. women who seek for definitive surgical sterilisation.
✓. women who planed for Elective bilateral salpingectomy or Salpingo-oophorectomy for a non-malignant indication

Exclusion criteria

✕. history of rectal surgery.
✕. rectovaginal endometriosis
✕. suspected malignancy
✕. History of pelvic inflammatory disease.
✕. active lower genital tract infection.
✕. Virgo women
✕. pregnancy
✕. Failure to provide written informed consent prior to surgery

What they're measuring

Successful removal of the fallopian tubes or adnexa without a need to convert to another technique.

Timeframe: Intraoperative

Trial details

NCT IDNCT05228938

SponsorHaEmek Medical Center, Israel

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-12-31

View on ClinicalTrials.gov More Salpingectomy trials