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Transvaginal Natural Orifice Transluminal Endoscopic Surgery- A New Approach to Salpingo-oophorectomy

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What is being tested

Laparoscopy

+ vNOTES

Procedure
Who is being recruted

From 18 to 80 Years
+8 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Other Study

Interventional
Study Start: July 2025
See protocol details

Summary

Principal SponsorSheba Medical Center
Study ContactAya Mohr-Sasson, M.D
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: July 3, 2025

Actual date on which the first participant was enrolled.

Natural Orifice Transluminal Endoscopic Surgery (NOTES) is an emerging field in minimally invasive surgery. NOTES can be performed via a variety of approaches, including through the stomach, esophagus, bladder, and rectum, but the majority of cases have been performed transvaginally (vNOTES). The vNOTES technique includes conventional, laparoscopic instruments that are inserted through a single-port device that enables the insertion of 1 10-mm trocar, and 4 5-mm trocars. The operation in carried out placing the patient in the lithotomy position. After completing general anaesthesia, a 2.5-cm posterior colpotomy is made. The pouch of Douglas is opened and the transvaginal natural orifice transluminal endoscopic surgery (vNOTES) port is inserted transvaginally. A pneumoperitoneum is created, and the pelvic cavity, including the uterus and the adnexa is demonstrated. Only then, the conventional laparoscopic instruments are inserted. By incorporating the advantages of endoscopic surgery, the vNOTES approach avoids abdominal wall wounds and trocar-related complications, including reducing post operation pain. Moreover, recent studies report, shorter hospital stay, improved visibility, and the possibility to circumvent extensive lysis of adhesion to reach the pelvic cavity. It should be mentioned that operative risks such as : anesthesia complications, excessive blood loss, damage to near organs ( intestines or bladder), and vasculature damage exists in both conventional laparoscopy and vNOTES approach. vNOTES technique has been used for hysterectomy and was proven to be just as good as laparoscopy with the advantage of daycare surgery. The use of vNOTES for salpingo-oophorectomy without concomitant hysterectomy has been questioned due to challenging accessibility. To the best of our knowledge, data concerning the experience using this technique for salpingo-oophorectomy is scarce and based on few published case-reports. Therefore, the aim of this study is to compare the common approach of laparoscopy for bilateral salpingo - oophorectomy to a new approach via transvaginal natural orifice transluminal endoscopic surgery (vNOTES). Material and methods This is a randomized prospective study including women admitted electively to a single care center for bilateral salpingo-oophorectomy due to benign indication. Women that will be found to fit inclusion criteria will get by the research team explanation on both techniques. After giving informed consent, all women will be allocated to one of two operative techniques by en-block randomization: 1. Laparoscopy 2. vNOTES Both operations will be done by a single highly skilled operator. All women will sign informed consent before admitted to operation room. Patient's demographics, characteristics, perioperative, operative and post-operative data will be collected from medical records. Data will be coded in order to save confidentiality ( each serial number will identify a patient. The list of serial numbers that fits each identification number will be available only for the principle investigator ).

Official TitleTransvaginal Natural Orifice Transluminal Endoscopic Surgery- A New Approach to Salpingo-oophorectomy
NCT04012710
Principal SponsorSheba Medical Center
Study ContactAya Mohr-Sasson, M.D
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

100 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Other Study

Some studies explore topics that don't fall into a specific category. These might include innovative research, new technologies, or emerging healthcare areas.


Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Female

Biological sex of participants that are eligible to enroll.

From 18 to 80 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

2 inclusion criteria required to participate
Elective surgery

Benign indication for surgery

6 exclusion criteria prevent from participating
Severe endometriosis

Past pelvic operations

Suspected malignancy

Combined planned hysterectomy

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Active Comparator
Abdominal conventional laparoscopy for salpingo-oophorectomy

Group II

Active Comparator
Transvaginal natural orifice transluminal endoscopic surgery for salpingo-oophorectomy

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Aya Mohr Sasson

Ramat Gan, IsraelOpen Aya Mohr Sasson in Google Maps
Recruiting soonOne Study Center
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