Randomized Study Comparing Endoscopic Transvaginal vNOTES Surgery to Laparoscopy in Terms of Postoperative Pain
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Hospices Civils de Lyon
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Pain score (VAS)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
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.
Intervention: vNOTES (Device)
laparoscopy
conventional laparoscopy
Intervention: laparoscopy (Procedure)
Outcomes
Primary Outcomes
Pain score (VAS)
Time Frame: Day 1 (the day after surgery)
Visual analogic scale (VAS) is used to evaluate from 0 (no pain) to 10 (unbearable pain)
Secondary Outcomes
- Surgery complications(Month 1)
- Pain score (VAS)(Day 0 (Hour 6 post surgery))
- ease of performing the technique score (VAS)(Day 0 (30 minutes after surgery))
- pain score (VAS)(Day 7)
- duration of surgery(Day 0 (30 minutes after surgery))
- outpatient care(Day 1)
- dose of morphine(Day 0 (2 hours post surgery))
- duration of analgesic(month 1)
- symptom improvement score(month 1)
- patient management costs(month 1)
- pain score (QDSA)(Day 7)
- dose of analgesic(month 1)
- patient satisfaction score(month 1)
- quality of life score(month 1)
- Pain score (VAS)(Day 0 (Hour 2 post surgery))
- pain score (QDSA)(Day 0 (Hour 6 post surgery))
- pain score (QDSA)(Day 1 (the day after surgery))
- dose of analgesic(Day 0 (2 hours post surgery))
- duration of analgesic(Day 0 (2 hours post surgery))
- dose of analgesic(Day 0 (8 hours post surgery))
- duration of analgesic(Day 0 (8 hours post surgery))