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low enrollment rate
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study group: vNOTES | Experimental | Elective bilateral salpingectomy or Salpingo-oophorectomy by vaginal Natural Orifice Transluminal Endoscopic Surgery approach |
|
| Control group: Laparoscopic | Other | Elective bilateral salpingectomy or Salpingo-oophorectomy by conventional laparoscopy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VNOTES | Procedure | vaginal Natural Orifice Transluminal Endoscopic Surgery approach for Elective bilateral salpingectomy or Salpingo-oophorectomy |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of surgical intervention | (Between incision and closure) in minutes | Intraoperative |
| Duration of hospital admission after surgical intervention | Between surgery and time of discharge - in days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| meirav braverman, MD | haemek medical center | Principal Investigator |
| Sivan Witzman | haemek medical center | Study Director |
| eyal rom, MD | haemek medical center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Haemek Medical Center | Afula | Israel |
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| ID | Term |
|---|---|
| D010535 | Laparoscopy |
| ID | Term |
|---|---|
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| laparoscopic | Procedure | laparoscopic Surgery approach for Elective bilateral salpingectomy or Salpingo-oophorectomy |
|
| 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 | 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 | 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. | During the first seven days after the surgical intervention |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| D019060 | Minimally Invasive Surgical Procedures |
| D013514 | Surgical Procedures, Operative |