vNOTES Transvaginal Endoscopic Surgery Versus Laparoscopy (NOTRANDO)

Civil Hospices of Lyon

Status: Enrolling

Conditions: Salpingectomy

Treatments: Procedure: laparoscopy; Device: vNOTES

Study type: Interventional

Funder types: Other

Identifiers

NCT04324034

69HCL19_1013

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

50 participants in 2 patient groups

vNOTES

Experimental group

Description:

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.

Treatment:

Device: vNOTES

laparoscopy

Active Comparator group

Description:

conventional laparoscopy

Treatment:

Procedure: laparoscopy