Vaginal Natural Orifice Trans-luminal Endoscopic Surgery Salpingectomy for Tubal Sterilization: Clinical Outcomes and Learning Curve Analysis

Study Overview
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Brief Summary
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The evolution from classical open surgery to laparoscopic surgery has led to a significant reduction of morbidity and mortality. Newer advances such as development of single port laparoscopic surgery and scarless Natural Orifice Transluminal Endoscopic Surgery (NOTES) have moved forward the practice in Minimally Invasive Surgery. Recently, clinical application of vNOTES has broadened significantly in the field of gynaecological surgery. As the application of vNOTES is increasing, it is deemed mandatory to assess the clinical outcomes and the learning curve (LC) of this novel technique. There is a paucity of reports in the literature analysing prospectively the clinical outcomes the LC of vNOTES in the gynaecological field. To the investigator's knowledge, there is no published prospective multicentre study that aims to evaluate the peri- and postoperative outcomes and the LC of salpingectomy for tubal sterilization by the technique of vNOTES.

Detailed Description
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The evolution from traditional open surgery to laparoscopic surgery has led to a significant reduction of morbidity and mortality. Newer advances such as development of single port laparoscopic surgery and scarless Natural Orifice Transluminal Endoscopic Surgery (NOTES) with or without robot assistance have moved forward the practice in Minimally Invasive Surgery. Described for the first time in 2004 at John Hopkins University in an experimental porcine model, NOTES is a surgical technique in which the natural orifices (mouth, vagina, urethra and rectum) are used as access routes to the peritoneal cavity for endoscopic surgery with no abdominal incisions. Clinical application of NOTES has been initially reported in general surgical procedures where Trans-gastric Appendectomy and Cholecystectomy have been performed using the mouth and the stomach as the access route. The technique seems to be feasible and safe when performed by experienced surgeons. Favourable outcomes such as reduced post-operative pain, a shorter length of hospital stay, improved cosmetic results due to scar-free surgery and reduced wound complications at trocar insertion sites, promote the increasing use of this new surgical technique. Although NOTES may be performed through various entries including the stomach, oesophagus, bladder and rectum, NOTES procedures in women have been commonly performed through the vagina as this allows direct access to the abdominal cavity. Therefore, trans-vaginal NOTES (vNOTES) has gained popularity among general surgeons, urologists and gastroenterologists over the past decade and was adopted in various surgical procedures, varying from cholecystectomy, appendectomy, sigmoidectomy, nephrectomy, splenectomy, liver resection and sleeve gastrectomy. Recently, clinical application of vNOTES has broadened significantly in the field of gynaecological surgery. The feasibility and safety of vNOTES in this specialty was firstly demonstrated in 2012. This event represented the key milestone in the evolution of vNOTES for gynaecologic procedures. Based on the current reports, we know that many of these procedures, such as oophorectomy, salpingectomy, adnexectomy, hysterectomy and many other more complex surgeries can be performed using vNOTES by the majority of surgeons who have adequate skills in performing laparoscopy. As the application of vNOTES is increasing, it is deemed mandatory to assess the learning curve (LC) of this novel technique. This is particularly important in surgery where new skills must be acquired constantly, safely and proficiently. It would be useful to know how many vNOTES procedures a surgeon may have to carry out before reaching an adequate level of safety and efficiency. Furthermore, a correct understanding of the LC is essential in randomised control trials comparing vNOTES with alternative types of surgery in order to reach valid conclusions. There is a paucity of reports in the literature analysing the LC of vNOTES. The learning curves for performing vNOTES hysterectomy and adnexal surgery have been previously assessed by retrospective studies, each conducted on a single surgeon basis and in a single institution (19-21). In a report published in June 2020, Lowenstein et al were among the first researchers that evaluated prospectively the learning curve of mastering the skills to perform vNOTES hysterectomy and uterosacral ligament suspension in two different centres. To the investigators knowledge, there is no published prospective multicentre study that aims to evaluate the feasibility, the LC, the peri- and postoperative outcomes of salpingectomy for tubal sterilization by the technique of vNOTES.

Official Title
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Vaginal Natural Orifice Trans-luminal Endoscopic Surgery (vNOTES) Salpingectomy for Tubal Sterilization: Clinical Outcomes and Learning Curve Analysis: A Multicentre Prospective Study

Conditions
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Tubal Sterilization

Intervention / Treatment
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* Procedure: Salpingectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 - 50 years Non-prolapsed uterus Asking for tubal sterilisation Any parity Written informed consent Exclusion Criteria: History of pelvic inflammatory disease. Recto-vaginal endometriosis. Suspicion of genital tract malignancy. Active lower genital tract infection. History of rectal surgery. Stage III or IV Uterine prolapse (defined by the International Continence Society classification). Complete obliteration of the posterior douglas pouch determined by pelvic examination. Virginity. Failure to provide written informed consent.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 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: Treatment
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Junior surgeons<br>The surgeons will be divided into 2 arms based on their surgical experience time: less than 5 years (junior surgeons) and more than 5 years (senior surgeons). The learning curve analysis will include 30 procedures for each surgeon group in each centre. For ethical reasons, all the junior surgeons will first assist the senior surgeons in performing vNOTES salpingectomy, as first assistant in at least 15 procedures, before starting to perform them as operators. | Procedure: Salpingectomy<br>* Salpingectomy by vaginal natural orifice transluminal endoscopic surgery (v-NOTES).<br>|
| Active Comparator: Senior surgeons<br>The surgeons will be divided into 2 arms based on their surgical experience time: less than 5 years (junior surgeons) and more than 5 years (senior surgeons). The learning curve analysis will include 30 procedures for each surgeon group in each centre. | Procedure: Salpingectomy<br>* Salpingectomy by vaginal natural orifice transluminal endoscopic surgery (v-NOTES).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of women successfully operated (salpingectomy) for tubal sterilization using vNOTES technique as a one day procedure. | The proportion of women who were successfully operated (salpingectomy) for tubal sterilization using vNOTES technique as a one day procedure will be measured as the primary outcome of effectiveness. Successful salpingectomy for tubal sterilization using vNOTES technique as a one day procedure is defined by: Complete retrieval of fallopian tube(s) (pathological confirmation). No conversion into laparoscopy or open surgery. Discharge from hospital on day 0 post-operatively. | 2 years | 
| Learning Curve Assessment. | The Assessment of the learning curve of salpingectomy by the technique of vNOTES in young and experienced surgeons is another primary outcome of our study. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraoperative or postoperative complications | Intraoperative or postoperative complications detected during the first 6 weeks of surgery and classified based on the Clavien-Dindo classification. | 6 weeks | 
| Postoperative pain scores | Postoperative pain scores measured using a visual analog scale twice a day from day 1 to 7. | 7 days | 
| Pain drugs intake | The total amount of pain drugs taken during the first week following surgery | 7 days | 
| Number of days of absence from work | Number of days of absence from work | 2 years | 
| Short Sexual Functioning Scale (SSFS) | Sexual well-being by self-reporting the Short Sexual Functioning Scale (SSFS). | baseline | 
| Short Sexual Functioning Scale (SSFS) | Sexual well-being by self-reporting the Short Sexual Functioning Scale (SSFS). | 3 months after baseline | 
| Short Sexual Functioning Scale (SSFS) | Sexual well-being by self-reporting the Short Sexual Functioning Scale (SSFS). | 6 months after baseline | 
| Pain on sexual intercourse | Occurrence and severity of pain on sexual intercourse self-reported by the patient by using a simple questionnaire. | baseline | 
| Pain on sexual intercourse | Occurrence and severity of pain on sexual intercourse self-reported by the patient by using a simple questionnaire. | 3 months after baseline | 
| Pain on sexual intercourse | Occurrence and severity of pain on sexual intercourse self-reported by the patient by using a simple questionnaire. | 6 months after baseline |