vNOTES Salpingo-oophorectomy or Bilateral Salpingectomy Compared With Laparoscopic.

Salpingectomy Clinical Trial

Official title:

Vaginal Natural Orifice Transluminal Endoscopic Surgery (vNOTES) Salpingo-oophorectomy or Bilateral Salpingectomy Compared With Laparoscopic Approach. Prospective Study-A New Approach.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05228938
• Other study ID #: 114-21
• Status: Terminated
• Phase: N/A
• Start date: May 29, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: March 2024
• Source: HaEmek Medical Center, Israel
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Objective: To compare the vNOTES approach versus conventional laparoscopic approach used in elective Salpingo-oophorectomy surgery for benign disease or bilateral salpingectomy for sterilization.

Study design: Prospective cohort, randomized controlled trial.

Study population: Planned Salpingo-oophorectomy for benign disease or bilateral salpingectomy for sterilization.

Primary outcome - Adherence to planned surgical route, intra-operative parameters & complications, post-operative parameters & complications, rate of satisfaction.

Description:

Objective: To compare the vNOTES approach versus conventional laparoscopic approach used in elective Salpingo-oophorectomy surgery for benign disease or bilateral salpingectomy for sterilization.

Study design: Prospective cohort, randomized controlled trial.

Study population: women aged over 18 who are planned to elective Salpingo-oophorectomy for benign disease or bilateral salpingectomy for sterilization.

Primary outcome - Removal of the ovaries and/or fallopian tubes according to the allocated technique, without conversion.

Secondary outcome - Duration of the surgical procedure, Duration of hospital admission (after surgery), The need for analgesics, and pain Numerical Rating Scale score , Post operation infection (up to 4 weeks from surgery), Need for medical examination/treatment or appearance of surgical complication up to 4 weeks form surgery (using Clavin Dindo Class), Bleeding assessment during surgery, Dyspareunia assessment - up to 3 months from surgery, Patient satisfaction from the surgical procedure will be measured with Patient Global Impression of Improvement (PGI-I).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Women aged between 18 and 80 years.

2. women who seek for definitive surgical sterilisation.

3. women who planed for Elective bilateral salpingectomy or Salpingo-oophorectomy for a non-malignant indication

Exclusion Criteria:

1. history of rectal surgery.

2. rectovaginal endometriosis

3. suspected malignancy

4. History of pelvic inflammatory disease.

5. active lower genital tract infection.

6. Virgo women

7. pregnancy

8. Failure to provide written informed consent prior to surgery

Related Conditions & MeSH terms

• Salpingectomy

Intervention

Procedure:
• VNOTES
vaginal Natural Orifice Transluminal Endoscopic Surgery approach for Elective bilateral salpingectomy or Salpingo-oophorectomy
• laparoscopic
laparoscopic Surgery approach for Elective bilateral salpingectomy or Salpingo-oophorectomy

Locations

Country	Name	City	State
Israel	Haemek Medical Center	Afula

Sponsors (1)

Lead Sponsor	Collaborator
HaEmek Medical Center, Israel

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Successful removal of the fallopian tubes or adnexa without a need to convert to another technique.	Number of Participants With Removal of the ovaries and/or fallopian tubes according to the allocated technique.	Intraoperative
Secondary	Duration of surgical intervention	(Between incision and closure) in minutes	Intraoperative
Secondary	Duration of hospital admission after surgical intervention	Between surgery and time of discharge - in days	from time of admission up to time of discharge from hospital
Secondary	Bleeding assessment during surgical intervention	Estimation by the major surgeon of the quantity of bleeding during surgery - in ml The amount of blood in the vacuum container in the end of the surgery	Intraoperative
Secondary	Post operation infection	Postoperative infection defined by lower abdominal pain with fever > 38°C and positive clinical signs or laboratory findings, detected during the first six weeks of surgery, as a dichotomous outcome	detected during the first six weeks of surgery
Secondary	Postoperative pain scores	Postoperative pain scores, measured using a Visual Analogue Scale (VAS) twice daily (morning and evening) from day 1 till 7 selfreported by the participating women. VAS scores from 0 to 10 with 0 = no pain and 10= worst pain ever imaginable.	During the first seven days after the surgical intervention
Secondary	The use of analgetic drugs for postoperative pain	Postoperative pain defined by the total amount of analgesics used, as a continuous outcome.	During the first week after the surgical intervention
Secondary	Intra- Operative Complications	Intra- operative complications according to the Clavien- Dindo classification detected during the first six weeks of surgery, as a dichotomous outcome	Intraoperative
Secondary	Postoperative Complications	Postoperative complications detected during the first 6 weeks of surgery, as a dichotomous outcome	During the first six weeks after the surgical intervention
Secondary	Vaginal Pain During Sexual Intercourse at Three Months	Incidence of vaginal dyspareunia recorded by the participants at 3 months by self-reporting using a simple questionnaire, as a dichotomous outcome	At 3 months after the surgical intervention
Secondary	Patient satisfaction from the surgical procedure	rate of satisfacation estimated with Patient Global Impression of Improvement questionnaire (PGI-I) . (score 1-7)	At 3 months after the surgical intervention
Secondary	Hospital Readmission	The number of women readmitted to hospital within six weeks following surgery, as a dichotomous outcome.	During the first six weeks after the surgical intervention