SalpingectomyNCT05228938
vNOTES Salpingo-oophorectomy or Bilateral Salpingectomy Compared With Laparoscopic.
A study testing VNOTES and laparoscopic in people with Salpingectomy, run by HaEmek Medical Center, Israel at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Salpingectomy
- What is being tested?
- VNOTES and laparoscopic
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteIsrael
- Study dates
- 29 May 2022to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Vaginal Natural Orifice Transluminal Endoscopic Surgery (vNOTES) Salpingo-oophorectomy or Bilateral Salpingectomy Compared With Laparoscopic Approach. Prospective Study-A New Approach.
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.
Read the detailed description
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: 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
- Salpingectomy
- Being tested
- VNOTES, laparoscopic
- Keywords
- VNOTES, laparoscopic, Salpingo-oophorectomy, salpingectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VNOTESProcedure or surgery
vaginal Natural Orifice Transluminal Endoscopic Surgery approach for Elective bilateral salpingectomy or Salpingo-oophorectomy
laparoscopicProcedure or surgery
laparoscopic Surgery approach for Elective bilateral salpingectomy or Salpingo-oophorectomy
| Study group | Role | What they receive |
|---|---|---|
| Study group: vNOTES | Experimental | Elective bilateral salpingectomy or Salpingo-oophorectomy by vaginal Natural Orifice Transluminal Endoscopic Surgery approach Receives: Procedure: VNOTES |
| Control group: Laparoscopic | Other | Elective bilateral salpingectomy or Salpingo-oophorectomy by conventional laparoscopy Receives: Procedure: laparoscopic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful removal of the fallopian tubes or adnexa without a need to convert to another technique.
Number of Participants With Removal of the ovaries and/or fallopian tubes according to the allocated technique.
Measured: Intraoperative
Secondary outcomes (11)
Duration of surgical intervention
(Between incision and closure) in minutes
Measured: Intraoperative
Duration of hospital admission after surgical intervention
Between surgery and time of discharge - in days
Measured: from time of admission up to time of discharge from hospital
Bleeding assessment during surgical intervention
Estimation by the major surgeon of the quantity of bleeding during surgery - in ml The amount of blood in the vacuum container in the end of the surgery
Measured: Intraoperative
Post operation infection
Postoperative infection defined by lower abdominal pain with fever > 38°C and positive clinical signs or laboratory findings, detected during the first six weeks of surgery, as a dichotomous outcome
Measured: detected during the first six weeks of surgery
Postoperative pain scores
Postoperative pain scores, measured using a Visual Analogue Scale (VAS) twice daily (morning and evening) from day 1 till 7 selfreported by the participating women. VAS scores from 0 to 10 with 0 = no pain and 10= worst pain ever imaginable.
Measured: During the first seven days after the surgical intervention
The use of analgetic drugs for postoperative pain
Postoperative pain defined by the total amount of analgesics used, as a continuous outcome.
Measured: During the first week after the surgical intervention
Intra- Operative Complications
Intra- operative complications according to the Clavien- Dindo classification detected during the first six weeks of surgery, as a dichotomous outcome
Measured: Intraoperative
Postoperative Complications
Postoperative complications detected during the first 6 weeks of surgery, as a dichotomous outcome
Measured: During the first six weeks after the surgical intervention
Vaginal Pain During Sexual Intercourse at Three Months
Incidence of vaginal dyspareunia recorded by the participants at 3 months by self-reporting using a simple questionnaire, as a dichotomous outcome
Measured: At 3 months after the surgical intervention
Patient satisfaction from the surgical procedure
rate of satisfacation estimated with Patient Global Impression of Improvement questionnaire (PGI-I) . (score 1-7)
Measured: At 3 months after the surgical intervention
Hospital Readmission
The number of women readmitted to hospital within six weeks following surgery, as a dichotomous outcome.
Measured: During the first six weeks after the surgical intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2022
- Study start29 May 2022
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Why it stopped: low enrollment rate
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SalpingectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- HaEmek Medical Center, Israel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Meirav Braverman, HaEmek Medical Center, Israel
- Investigators
- meirav braverman, MD, Principal investigator, haemek medical centerSivan Witzman, Study director, haemek medical centereyal rom, MD, Principal investigator, haemek medical center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05228938
- Sponsor's protocol ID
- 114-21
- Status last verified
- Mar 2024
- First submitted
- 2 Nov 2021
- Last updated
- 2 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vaginal Natural Orifice Transluminal Endoscopic Surgery (vNOTES) Salpingo-oophorectomy or Bilateral Salpingectomy Compared With Laparoscopic Approach. Prospective Study-A New Approach.
- ClinicalTrials.gov ID
- NCT05228938
- Acronym / sponsor ID
- 114-21
- Conditions
- Salpingectomy
- Keywords
- VNOTES, laparoscopic, Salpingo-oophorectomy, salpingectomy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: low enrollment rate
- Enrolment
- 1 participants (actual)
- Lead sponsor
- HaEmek Medical Center, IsraelUniversity, hospital or other
- Study start
- 29 May 2022 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 8 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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: 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).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group: vNOTES | Experimental | Procedure: VNOTESElective bilateral salpingectomy or Salpingo-oophorectomy by vaginal Natural Orifice Transluminal Endoscopic Surgery approach |
| Control group: Laparoscopic | Other | Procedure: laparoscopicElective bilateral salpingectomy or Salpingo-oophorectomy by conventional laparoscopy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- history of rectal surgery.
- rectovaginal endometriosis
- suspected malignancy
- History of pelvic inflammatory disease.
- active lower genital tract infection.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VNOTESvaginal Natural Orifice Transluminal Endoscopic Surgery approach for Elective bilateral salpingectomy or Salpingo-oophorectomy | Procedure or surgery | Study group: vNOTES |
| laparoscopiclaparoscopic Surgery approach for Elective bilateral salpingectomy or Salpingo-oophorectomy | Procedure or surgery | Control group: Laparoscopic |
Primary outcome
Successful removal of the fallopian tubes or adnexa without a need to convert to another technique.
Time frame: Intraoperative
Number of Participants With Removal of the ovaries and/or fallopian tubes according to the allocated technique.
11 secondary outcomes
Duration of surgical intervention
Time frame: Intraoperative
Duration of hospital admission after surgical intervention
Time frame: from time of admission up to time of discharge from hospital
Bleeding assessment during surgical intervention
Time frame: Intraoperative
Post operation infection
Time frame: detected during the first six weeks of surgery
Postoperative pain scores
Time frame: During the first seven days after the surgical intervention
The use of analgetic drugs for postoperative pain
Time frame: During the first week after the surgical intervention
Intra- Operative Complications
Time frame: Intraoperative
Postoperative Complications
Time frame: During the first six weeks after the surgical intervention
Vaginal Pain During Sexual Intercourse at Three Months
Time frame: At 3 months after the surgical intervention
Patient satisfaction from the surgical procedure
Time frame: At 3 months after the surgical intervention
Hospital Readmission
Time frame: During the first six weeks after the surgical intervention
Results and safety
The study was stopped early (reason given: low enrollment rate). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
meirav braverman, MD principal investigator
haemek medical center
Sivan Witzman study director
haemek medical center
eyal rom, MD principal investigator
haemek medical center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VNOTES and laparoscopic in people with Salpingectomy, run by HaEmek Medical Center, Israel at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 2 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: low enrollment rate). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful removal of the fallopian tubes or adnexa without a need to convert to another technique. (time frame: Intraoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2024; AzTrials last refreshed its copy on 30 Oct 2026.