vNOTES Transvaginal Endoscopic Surgery Versus Laparoscopy

Salpingectomy Clinical Trial

— NOTRANDO  

Official title:

Randomized Study Comparing Endoscopic Transvaginal vNOTES Surgery to Laparoscopy in Terms of Postoperative Pain

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04324034
• Other study ID #: 69HCL19_1013
• Status: Recruiting
• Phase: N/A
• Start date: June 3, 2021
• Est. completion date: January 2, 2026

Study information

• Verified date: February 2023
• Source: Hospices Civils de Lyon
• Contact: Gery LAMBLIN, Pr
• Phone: (0)4 72 35 58 71
• Email: gery.lamblin[@]chu-lyon.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: January 2, 2026
• Est. primary completion date: January 2, 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Salpingectomy

Intervention

Device:
• 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.

Procedure:
• laparoscopy
The surgery by conventional laparoscopy is used

Locations

Country	Name	City	State
France	Hospices Civils de Lyon	Bron

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Pain score (VAS)	Visual analogic scale (VAS) is used to evaluate from 0 (no pain) to 100 mm (unbearable pain)	Day 0 (Hour 2 post surgery)
Secondary	Pain score (VAS)	Visual analogic scale (VAS) is used to evaluate from 0 (no pain) to 100 mm (unbearable pain)	Day 0 (Hour 6 post surgery)
Secondary	pain score (VAS)	Visual analogic scale (VAS) is used to evaluate from 0 (no pain) to 100 mm (unbearable pain)	Day 7
Secondary	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	Day 0 (Hour 6 post surgery)
Secondary	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	Day 1 (the day after surgery)
Secondary	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	Day 7
Secondary	ease of performing the technique score (VAS)	Visual analogic scale (VAS) is used to evaluate from 0 (very easy) to 100 mm (very difficult).	Day 0 (30 minutes after surgery)
Secondary	duration of surgery	duration of surgery (between incision and closure) in minutes	Day 0 (30 minutes after surgery)
Secondary	Surgery complications	Description of all per and postoperative complications	Month 1
Secondary	outpatient care	number of patients discharged from hospital on the same day of the intervention	Day 1
Secondary	dose of morphine	total dose of morphine (mg) administered in the post-interventional surveillance room	Day 0 (2 hours post surgery)
Secondary	dose of analgesic	total administered dose of analgesic supplement (mg) in post-interventional monitoring room	Day 0 (2 hours post surgery)
Secondary	duration of analgesic	duration of analgesic treatment (min) in post-interventional monitoring room	Day 0 (2 hours post surgery)
Secondary	dose of analgesic	total administered dose of analgesics (mg) during the hospital stay	Day 0 (8 hours post surgery)
Secondary	duration of analgesic	duration of analgesic treatment (hours) during the hospital stay	Day 0 (8 hours post surgery)
Secondary	dose of analgesic	total administered dose of analgesics (mg) during the month following the surgery	month 1
Secondary	duration of analgesic	duration of analgesic treatment (days) during the month following the surgery	month 1
Secondary	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.	month 1
Secondary	symptom improvement score	assessed by the questionnaire PGI-I (Patient Global Impression of Improvement ) (from 1 "much better" to 7 "much worse")	month 1
Secondary	patient satisfaction score	Visual analogic scale (VAS) is used to evaluate from 0 (not at all satisfied) to 100 mm (very satisfied).	month 1
Secondary	patient management costs	Patient management costs according to the two surgical strategies	month 1