vNOTES Transvaginal Endoscopic Surgery Versus Laparoscopy

NCT04324034 | Unknown

• 1 other identifier: 69HCL19_1013
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Salpingectomy

Keywords

vNOTES; laparoscopy; salpingectomy; pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (21)

• Pain score (VAS)

  Day 0 (Hour 2 post surgery)

• Pain score (VAS)

  Day 0 (Hour 6 post surgery)

• pain score (VAS)

  Day 7

• pain score (QDSA)

  Day 0 (Hour 6 post surgery)

• pain score (QDSA)

  Day 1 (the day after surgery)

Study Arms (2)

vNOTES

EXPERIMENTAL

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

laparoscopy

ACTIVE COMPARATOR

conventional laparoscopy

Procedure: laparoscopy

Interventions

vNOTES DEVICE

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.

vNOTES

laparoscopy PROCEDURE

The surgery by conventional laparoscopy is used

laparoscopy

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Hospices Civils de Lyon

Bron, 69677, France

RECRUITING

MeSH Terms

Conditions

Pain

Interventions

Laparoscopy

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative

Central Study Contacts

Gery LAMBLIN, Pr

CONTACT

(0)4 72 35 58 71; gery.lamblin@chu-lyon.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2020
• First Posted: March 27, 2020
• Study Start: June 3, 2021
• Primary Completion: January 2, 2026
• Study Completion: January 2, 2026
• Last Updated: February 8, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)