vNOTES for Salpingo-oophorectomy

Surgery Clinical Trial

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

Status Not yet recruiting

Clinical Trial Summary

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).

Clinical Trial Description

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 ). ;

Related Conditions & MeSH terms

• Surgery

• NCT number: NCT04012710
• Study type: Interventional
• Source: Sheba Medical Center
• Contact: Aya Mohr-Sasson, M.D
• Phone: 0523692906
• Email: mohraya@gmail.com
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 3, 2024
• Completion date: July 1, 2025