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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
50
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.
The surgery by conventional laparoscopy is used
Hospices Civils de Lyon
Bron, France
RECRUITINGPain score (VAS)
Visual analogic scale (VAS) is used to evaluate from 0 (no pain) to 10 (unbearable pain)
Time frame: Day 1 (the day after surgery)
Pain score (VAS)
Visual analogic scale (VAS) is used to evaluate from 0 (no pain) to 100 mm (unbearable pain)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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).
Time frame: Day 0 (30 minutes after surgery)
duration of surgery
duration of surgery (between incision and closure) in minutes
Time frame: Day 0 (30 minutes after surgery)
Surgery complications
Description of all per and postoperative complications
Time frame: Month 1
outpatient care
number of patients discharged from hospital on the same day of the intervention
Time frame: Day 1
dose of morphine
total dose of morphine (mg) administered in the post-interventional surveillance room
Time frame: Day 0 (2 hours post surgery)
dose of analgesic
total administered dose of analgesic supplement (mg) in post-interventional monitoring room
Time frame: Day 0 (2 hours post surgery)
duration of analgesic
duration of analgesic treatment (min) in post-interventional monitoring room
Time frame: Day 0 (2 hours post surgery)
dose of analgesic
total administered dose of analgesics (mg) during the hospital stay
Time frame: Day 0 (8 hours post surgery)
duration of analgesic
duration of analgesic treatment (hours) during the hospital stay
Time frame: Day 0 (8 hours post surgery)
dose of analgesic
total administered dose of analgesics (mg) during the month following the surgery
Time frame: month 1
duration of analgesic
duration of analgesic treatment (days) during the month following the surgery
Time frame: 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.
Time frame: month 1
symptom improvement score
assessed by the questionnaire PGI-I (Patient Global Impression of Improvement ) (from 1 "much better" to 7 "much worse")
Time frame: month 1
patient satisfaction score
Visual analogic scale (VAS) is used to evaluate from 0 (not at all satisfied) to 100 mm (very satisfied).
Time frame: month 1
patient management costs
Patient management costs according to the two surgical strategies
Time frame: month 1
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