vNOTES Salpingo-oophorectomy or Bilateral Salpingectomy Compared With Laparoscopic.

Study Overview
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Brief Summary
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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
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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).

Official Title
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Vaginal Natural Orifice Transluminal Endoscopic Surgery (vNOTES) Salpingo-oophorectomy or Bilateral Salpingectomy Compared With Laparoscopic Approach. Prospective Study-A New Approach.

Conditions
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Salpingectomy

Intervention / Treatment
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* Procedure: VNOTES
* Procedure: laparoscopic


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

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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No

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study group: vNOTES<br>Elective bilateral salpingectomy or Salpingo-oophorectomy by vaginal Natural Orifice Transluminal Endoscopic Surgery approach | Procedure: VNOTES<br>* vaginal Natural Orifice Transluminal Endoscopic Surgery approach for Elective bilateral salpingectomy or Salpingo-oophorectomy<br>|
| Other: Control group: Laparoscopic<br>Elective bilateral salpingectomy or Salpingo-oophorectomy by conventional laparoscopy | Procedure: laparoscopic<br>* laparoscopic Surgery approach for Elective bilateral salpingectomy or Salpingo-oophorectomy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Intraoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of surgical intervention | (Between incision and closure) in minutes | Intraoperative | 
| Duration of hospital admission after surgical intervention | Between surgery and time of discharge - in days | 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 | 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 | 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. | 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. | 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 | Intraoperative | 
| Postoperative Complications | Postoperative complications detected during the first 6 weeks of surgery, as a dichotomous outcome | 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 | 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) | 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. | During the first six weeks after the surgical intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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VNOTES, laparoscopic, Salpingo-oophorectomy, salpingectomy