vNOTES Transvaginal Endoscopic Surgery Versus Laparoscopy (NOTRANDO)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Salpingectomy
• Intervention / Treatment: Device: vNOTES; Procedure: laparoscopy

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Bron, France, 69677
    • Recruiting
    • Hospices Civils de LYON
    • Contact: LAMBLIN Géry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	Device: 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.
ACTIVE_COMPARATOR: laparoscopy; conventional laparoscopy	Procedure: laparoscopy; The surgery by conventional laparoscopy is used

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 3, 2021
• Primary Completion (ANTICIPATED): January 2, 2026
• Study Completion (ANTICIPATED): January 2, 2026

Study Registration Dates

• First Submitted: March 25, 2020
• First Submitted That Met QC Criteria: March 25, 2020
• First Posted (ACTUAL): March 27, 2020

Study Record Updates

• Last Update Posted (ACTUAL): February 8, 2023
• Last Update Submitted That Met QC Criteria: February 6, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: pain; laparoscopy; salpingectomy; vNOTES
• Other Study ID Numbers: 69HCL19_1013

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No