vNOTES Transvaginal Endoscopic Surgery Versus Laparoscopy

Not Applicable

Recruiting

• Conditions: Salpingectomy
• Interventions: Device: vNOTES; Procedure: laparoscopy

• Registration Number: NCT04324034
• Lead Sponsor: Hospices Civils de Lyon

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-03-25
• Study First Submitted QC: 2020-03-25
• Study First Posted: 2020-03-27
• Study Start: 2021-06-03
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-06
• Last Update Posted: 2023-02-08
• Primary Completion: 2026-01-02
• Study Completion: 2026-01-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 50

Inclusion Criteria

• planned surgery procedure : bilateral salpingectomy for outpatient benign indication
• patients with free, informed and signed consent

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
vNOTES	vNOTES	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.
laparoscopy	laparoscopy	conventional laparoscopy

Primary Outcome Measures

Name	Time	Method
Pain score (VAS)	Day 1 (the day after surgery)	Visual analogic scale (VAS) is used to evaluate from 0 (no pain) to 10 (unbearable pain)

Secondary Outcome Measures

Name	Time	Method
Surgery complications	Month 1	Description of all per and postoperative complications
Pain score (VAS)	Day 0 (Hour 6 post surgery)	Visual analogic scale (VAS) is used to evaluate from 0 (no pain) to 100 mm (unbearable pain)
ease of performing the technique score (VAS)	Day 0 (30 minutes after surgery)	Visual analogic scale (VAS) is used to evaluate from 0 (very easy) to 100 mm (very difficult).
pain score (VAS)	Day 7	Visual analogic scale (VAS) is used to evaluate from 0 (no pain) to 100 mm (unbearable pain)
duration of surgery	Day 0 (30 minutes after surgery)	duration of surgery (between incision and closure) in minutes
outpatient care	Day 1	number of patients discharged from hospital on the same day of the intervention
dose of morphine	Day 0 (2 hours post surgery)	total dose of morphine (mg) administered in the post-interventional surveillance room
duration of analgesic	month 1	duration of analgesic treatment (days) during the month following the surgery
symptom improvement score	month 1	assessed by the questionnaire PGI-I (Patient Global Impression of Improvement ) (from 1 "much better" to 7 "much worse")
patient management costs	month 1	Patient management costs according to the two surgical strategies
pain score (QDSA)	Day 7	Pain score assessed by QDSA short questionnaire (Saint-Antoine Pain Questionnaire) : list of 16 qualifiers to describe pain, score ranging from 0 to 64
dose of analgesic	month 1	total administered dose of analgesics (mg) during the month following the surgery
patient satisfaction score	month 1	Visual analogic scale (VAS) is used to evaluate from 0 (not at all satisfied) to 100 mm (very satisfied).
quality of life score	month 1	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.

Trial Locations

Locations (1)

Hospices Civils de Lyon; 🇫🇷 Bron, France