Clinical trial NCT04324034: vNOTES Transvaginal Endoscopic Surgery Versus Laparoscopy
Official title: Randomized Study Comparing Endoscopic Transvaginal vNOTES Surgery to Laparoscopy in Terms of Postoperative Pain
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Salpingectomy
Keywords: vNOTES
laparoscopy
salpingectomy
pain
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2020-03-27
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Pain score (VAS)
timeFrame: Day 1 (the day after surgery)
Secondary outcomes:
measure: Pain score (VAS)
timeFrame: Day 0 (Hour 2 post surgery)
measure: Pain score (VAS)
timeFrame: Day 0 (Hour 6 post surgery)
measure: pain score (VAS)
timeFrame: Day 7
measure: pain score (QDSA)
timeFrame: Day 0 (Hour 6 post surgery)
measure: pain score (QDSA)
timeFrame: Day 1 (the day after surgery)
measure: pain score (QDSA)
timeFrame: Day 7
measure: ease of performing the technique score (VAS)
timeFrame: Day 0 (30 minutes after surgery)
measure: duration of surgery
timeFrame: Day 0 (30 minutes after surgery)
measure: Surgery complications
timeFrame: Month 1
measure: outpatient care
timeFrame: Day 1
measure: dose of morphine
timeFrame: Day 0 (2 hours post surgery)
measure: dose of analgesic
timeFrame: Day 0 (2 hours post surgery)
measure: duration of analgesic
timeFrame: Day 0 (2 hours post surgery)
measure: dose of analgesic
timeFrame: Day 0 (8 hours post surgery)
measure: duration of analgesic
timeFrame: Day 0 (8 hours post surgery)
measure: dose of analgesic
timeFrame: month 1
measure: duration of analgesic
timeFrame: month 1
measure: quality of life score
timeFrame: month 1
measure: symptom improvement score
timeFrame: month 1
measure: patient satisfaction score
timeFrame: month 1
measure: patient management costs
timeFrame: month 1
Other outcomes:
Locations:
city: Bron
country: France
facility: Hospices Civils de Lyon
Study officials:
References: