vNOTES Transvaginal Endoscopic Surgery Versus Laparoscopy

Study Overview
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Brief Summary
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The feasibility and safety of laparoscopy are no longer to be demonstrated, especially in the field of gynecology, but this technique often causes post-operative pain. New techniques are being developed to overcome the inconvenience of laparoscopy, notably endoscopic transluminal surgery using a natural orifice (NOTES). It avoids incisions and therefore scarring, and could reduce post-operative pain. It is now developing in the field of transvaginal gynecology (vNOTES). This study is the first prospective randomized study comparing the vNOTES technique to laparoscopy with postoperative pain assessment for performing a salpingectomy. The hypothesis is that the use of vNOTES transvaginal endoscopic surgery would reduce the post-operative pain of patients compared to laparoscopy in the context of a salpingectomy.

Official Title
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Randomized Study Comparing Endoscopic Transvaginal vNOTES Surgery to Laparoscopy in Terms of Postoperative Pain

Conditions
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Salpingectomy

Intervention / Treatment
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* Device: vNOTES
* Procedure: laparoscopy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: planned surgery procedure : bilateral salpingectomy for outpatient benign indication patients with free, informed and signed consent Exclusion Criteria: disorders leading to an unacceptable risk of postoperative complications sought during the interrogation of the patient (disorders of blood coagulation, disorders of the immune system, progressive diseases ....) pregnancy or wish for subsequent pregnancy lactating women intervention in the context of pelvic cancer history of uni- or bilateral salpingectomy contraindication to laparoscopy history of rectal surgery endometriosis pelvic inflammatory disease genital infection not eligible for outpatient care associated surgical procedure planned during the intervention (hysterectomy, sub-urethral strip, prolapse cure ...) participation in another interventional research related to the gynecological sphere inability to understand the information given a person not affiliated to a social security scheme, or deprived of liberty, or under guardianship.

Ages Eligible for Study
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Minimum Age: 18 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: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: vNOTES<br>vaginal Natural Orifice Transluminal Endoscopic Surgery (vNOTES) is vaginal surgery with a natural approach. The GelPOINT V-path transvaginal access platform is used. It is a device designed to be placed transvaginally to establish a pathway for the insertion of minimally invasive instruments while maintaining insufflation to perform diagnostic or operative procedures. This device also allows a passage for the extraction of operating parts. | Device: vNOTES<br>* vaginal Natural Orifice Transluminal Endoscopic Surgery (vNOTES) is vaginal surgery with a natural approach. The GelPOINT V-path transvaginal access platform is used. It is a device designed to be placed transvaginally to establish a pathway for the insertion of minimally invasive instruments while maintaining insufflation to perform diagnostic or operative procedures. This device also allows a passage for the extraction of operating parts.<br>|
| Active Comparator: laparoscopy<br>conventional laparoscopy | Procedure: laparoscopy<br>* The surgery by conventional laparoscopy is used<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain score (VAS) | Visual analogic scale (VAS) is used to evaluate from 0 (no pain) to 10 (unbearable pain) | Day 1 (the day after surgery) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain score (VAS) | Visual analogic scale (VAS) is used to evaluate from 0 (no pain) to 100 mm (unbearable pain) | Day 0 (Hour 2 post surgery) | 
| Pain score (VAS) | Visual analogic scale (VAS) is used to evaluate from 0 (no pain) to 100 mm (unbearable pain) | Day 0 (Hour 6 post surgery) | 
| pain score (VAS) | Visual analogic scale (VAS) is used to evaluate from 0 (no pain) to 100 mm (unbearable pain) | Day 7 | 
| pain score (QDSA) | Pain score assessed by QDSA short questionnaire (Saint-Antoine Pain Questionnaire) : list of 16 qualifiers to describe pain, score ranging from 0 to 64 | Day 0 (Hour 6 post surgery) | 
| pain score (QDSA) | Pain score assessed by QDSA short questionnaire (Saint-Antoine Pain Questionnaire) : list of 16 qualifiers to describe pain, score ranging from 0 to 64 | Day 1 (the day after surgery) | 
| pain score (QDSA) | Pain score assessed by QDSA short questionnaire (Saint-Antoine Pain Questionnaire) : list of 16 qualifiers to describe pain, score ranging from 0 to 64 | Day 7 | 
| ease of performing the technique score (VAS) | Visual analogic scale (VAS) is used to evaluate from 0 (very easy) to 100 mm (very difficult). | Day 0 (30 minutes after surgery) | 
| duration of surgery | duration of surgery (between incision and closure) in minutes | Day 0 (30 minutes after surgery) | 
| Surgery complications | Description of all per and postoperative complications | Month 1 | 
| outpatient care | number of patients discharged from hospital on the same day of the intervention | Day 1 | 
| dose of morphine | total dose of morphine (mg) administered in the post-interventional surveillance room | Day 0 (2 hours post surgery) | 
| dose of analgesic | total administered dose of analgesic supplement (mg) in post-interventional monitoring room | Day 0 (2 hours post surgery) | 
| duration of analgesic | duration of analgesic treatment (min) in post-interventional monitoring room | Day 0 (2 hours post surgery) | 
| dose of analgesic | total administered dose of analgesics (mg) during the hospital stay | Day 0 (8 hours post surgery) | 
| duration of analgesic | duration of analgesic treatment (hours) during the hospital stay | Day 0 (8 hours post surgery) | 
| dose of analgesic | total administered dose of analgesics (mg) during the month following the surgery | month 1 | 
| duration of analgesic | duration of analgesic treatment (days) during the month following the surgery | month 1 | 
| quality of life score | assessed by the questionnaire SF-12 (abridged version of the Medical Outcomes Study Short-Form General Health Survey SF-36). It allows to obtain 2 scores: mental and social score (from 5.89058 to 71.966825) and physical score (from 9.94738 to 70.02246). The average of this scores in the general population is 50. | month 1 | 
| symptom improvement score | assessed by the questionnaire PGI-I (Patient Global Impression of Improvement ) (from 1 much better to 7 much worse) | month 1 | 
| patient satisfaction score | Visual analogic scale (VAS) is used to evaluate from 0 (not at all satisfied) to 100 mm (very satisfied). | month 1 | 
| patient management costs | Patient management costs according to the two surgical strategies | month 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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vNOTES, laparoscopy, salpingectomy, pain