vNOTES Salpingo-oophorectomy or Bilateral Salpingectomy Compared With Laparoscopic.
NCT ID: NCT05228938
Last Updated: 2024-04-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
1 participants
INTERVENTIONAL
2022-05-29
2023-12-31
Brief Summary
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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.
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Detailed Description
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Study design: Prospective cohort, randomized controlled trial.
Study population: women aged over 18 who are planned to elective Salpingo-oophorectomy for benign disease or bilateral salpingectomy for sterilization.
Primary outcome - Removal of the ovaries and/or fallopian tubes according to the allocated technique, without conversion.
Secondary outcome - Duration of the surgical procedure, Duration of hospital admission (after surgery), The need for analgesics, and pain Numerical Rating Scale score , Post operation infection (up to 4 weeks from surgery), Need for medical examination/treatment or appearance of surgical complication up to 4 weeks form surgery (using Clavin Dindo Class), Bleeding assessment during surgery, Dyspareunia assessment - up to 3 months from surgery, Patient satisfaction from the surgical procedure will be measured with Patient Global Impression of Improvement (PGI-I).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
DOUBLE
Study Groups
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Study group: vNOTES
Elective bilateral salpingectomy or Salpingo-oophorectomy by vaginal Natural Orifice Transluminal Endoscopic Surgery approach
VNOTES
vaginal Natural Orifice Transluminal Endoscopic Surgery approach for Elective bilateral salpingectomy or Salpingo-oophorectomy
Control group: Laparoscopic
Elective bilateral salpingectomy or Salpingo-oophorectomy by conventional laparoscopy
laparoscopic
laparoscopic Surgery approach for Elective bilateral salpingectomy or Salpingo-oophorectomy
Interventions
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VNOTES
vaginal Natural Orifice Transluminal Endoscopic Surgery approach for Elective bilateral salpingectomy or Salpingo-oophorectomy
laparoscopic
laparoscopic Surgery approach for Elective bilateral salpingectomy or Salpingo-oophorectomy
Eligibility Criteria
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Inclusion Criteria
2. women who seek for definitive surgical sterilisation.
3. women who planed for Elective bilateral salpingectomy or Salpingo-oophorectomy for a non-malignant indication
Exclusion Criteria
2. rectovaginal endometriosis
3. suspected malignancy
4. History of pelvic inflammatory disease.
5. active lower genital tract infection.
6. Virgo women
7. pregnancy
8. Failure to provide written informed consent prior to surgery
18 Years
80 Years
FEMALE
No
Sponsors
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HaEmek Medical Center, Israel
OTHER
Responsible Party
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Meirav Braverman
Principal Investigator
Principal Investigators
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meirav braverman, MD
Role: PRINCIPAL_INVESTIGATOR
haemek medical center
Sivan Witzman
Role: STUDY_DIRECTOR
haemek medical center
eyal rom, MD
Role: PRINCIPAL_INVESTIGATOR
haemek medical center
Locations
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Haemek Medical Center
Afula, , Israel
Countries
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Other Identifiers
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114-21
Identifier Type: -
Identifier Source: org_study_id
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