vNOTES for Salpingo-oophorectomy

Study Overview
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Brief Summary
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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).

Detailed Description
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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: Laparoscopy 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 Title
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Transvaginal Natural Orifice Transluminal Endoscopic Surgery- A New Approach to Salpingo-oophorectomy

Conditions
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Surgery

Intervention / Treatment
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* Procedure: Laparoscopy
* Procedure: vNOTES


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Elective surgery Benign indication for surgery Exclusion Criteria: Severe endometriosis Past pelvic operations Suspected malignancy Combined planned hysterectomy Recurrent Pelvic Inflammatory disease (PID) Vaginal anomaly

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Laparoscopy<br>Abdominal conventional laparoscopy for salpingo-oophorectomy | Procedure: Laparoscopy<br>* Conventional abdominal laparoscopy<br>|
| Active Comparator: vNOTES<br>Transvaginal natural orifice transluminal endoscopic surgery for salpingo-oophorectomy | Procedure: vNOTES<br>* Transvaginal natural orifice transluminal endoscopic surgery for salpingo-oophorectomy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intra - Operative complication rate | Complications during operation as a compound outcome including - bleeding. damage to neer organs and vasculature damage | Intra - Operative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Woman satisfaction rate post operation | Satisfaction rate estimated by VAS -Visual Analogue Scale - A numeric satisfactory rating scale scoring 0 to 10, while 0 is not satisfied at all and 10 is highly satisfied . | Estimated on post operation day -1- through study completion, an average of 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Transvaginal natural orifice transluminal endoscopic surgery, Salpingo-oophorectomy, Laparoscopy