Salpingectomy
Conditions
Keywords
VNOTES, laparoscopic, Salpingo-oophorectomy, salpingectomy
Brief 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.
Detailed 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).
Interventions
PROCEDUREVNOTES
vaginal Natural Orifice Transluminal Endoscopic Surgery approach for Elective bilateral salpingectomy or Salpingo-oophorectomy
PROCEDURElaparoscopic
laparoscopic Surgery approach for Elective bilateral salpingectomy or Salpingo-oophorectomy
Sponsors
HaEmek Medical Center, Israel
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Successful removal of the fallopian tubes or adnexa without a need to convert to another technique. | Intraoperative | Number of Participants With Removal of the ovaries and/or fallopian tubes according to the allocated technique. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of hospital admission after surgical intervention | from time of admission up to time of discharge from hospital | Between surgery and time of discharge - in days |
| Bleeding assessment during surgical intervention | Intraoperative | 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 |
| Post operation infection | detected during the first six weeks of surgery | 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 |
| Postoperative pain scores | During the first seven days after the surgical intervention | 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. |
| The use of analgetic drugs for postoperative pain | During the first week after the surgical intervention | Postoperative pain defined by the total amount of analgesics used, as a continuous outcome. |
| Duration of surgical intervention | Intraoperative | (Between incision and closure) in minutes |
| Postoperative Complications | During the first six weeks after the surgical intervention | Postoperative complications detected during the first 6 weeks of surgery, as a dichotomous outcome |
| Vaginal Pain During Sexual Intercourse at Three Months | At 3 months after the surgical intervention | Incidence of vaginal dyspareunia recorded by the participants at 3 months by self-reporting using a simple questionnaire, as a dichotomous outcome |
| Patient satisfaction from the surgical procedure | At 3 months after the surgical intervention | rate of satisfacation estimated with Patient Global Impression of Improvement questionnaire (PGI-I) . (score 1-7) |
| Hospital Readmission | During the first six weeks after the surgical intervention | The number of women readmitted to hospital within six weeks following surgery, as a dichotomous outcome. |
| Intra- Operative Complications | Intraoperative | Intra- operative complications according to the Clavien- Dindo classification detected during the first six weeks of surgery, as a dichotomous outcome |
Countries
Israel
Outcome results
None listed