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.
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Enrollment
1
vaginal Natural Orifice Transluminal Endoscopic Surgery approach for Elective bilateral salpingectomy or Salpingo-oophorectomy
laparoscopic Surgery approach for Elective bilateral salpingectomy or Salpingo-oophorectomy
Haemek Medical Center
Afula, Israel
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.
Time frame: Intraoperative
Duration of surgical intervention
(Between incision and closure) in minutes
Time frame: Intraoperative
Duration of hospital admission after surgical intervention
Between surgery and time of discharge - in days
Time frame: from time of admission up to time of discharge from hospital
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
Time frame: Intraoperative
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
Time frame: detected during the first six weeks of surgery
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.
Time frame: During the first seven days after the surgical intervention
The use of analgetic drugs for postoperative pain
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Postoperative pain defined by the total amount of analgesics used, as a continuous outcome.
Time frame: During the first week after the surgical intervention
Intra- Operative Complications
Intra- operative complications according to the Clavien- Dindo classification detected during the first six weeks of surgery, as a dichotomous outcome
Time frame: Intraoperative
Postoperative Complications
Postoperative complications detected during the first 6 weeks of surgery, as a dichotomous outcome
Time frame: During the first six weeks after the surgical intervention
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
Time frame: At 3 months after the surgical intervention
Patient satisfaction from the surgical procedure
rate of satisfacation estimated with Patient Global Impression of Improvement questionnaire (PGI-I) . (score 1-7)
Time frame: At 3 months after the surgical intervention
Hospital Readmission
The number of women readmitted to hospital within six weeks following surgery, as a dichotomous outcome.
Time frame: During the first six weeks after the surgical intervention