Clinical trial NCT05228938: vNOTES Salpingo-oophorectomy or Bilateral Salpingectomy Compared With Laparoscopic.
Official title: Vaginal Natural Orifice Transluminal Endoscopic Surgery (vNOTES) Salpingo-oophorectomy or Bilateral Salpingectomy Compared With Laparoscopic Approach. Prospective Study-A New Approach.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Salpingectomy
Keywords: VNOTES
laparoscopic
Salpingo-oophorectomy
salpingectomy
Lead sponsor: HaEmek Medical Center, Israel
Sponsor class: OTHER
First posted: 2022-02-08
Enrollment: 1
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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).

Eligibility criteria: 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

Primary outcomes:
measure: Successful removal of the fallopian tubes or adnexa without a need to convert to another technique.
timeFrame: Intraoperative
Secondary outcomes:
measure: Duration of surgical intervention
timeFrame: Intraoperative
measure: Duration of hospital admission after surgical intervention
timeFrame: from time of admission up to time of discharge from hospital
measure: Bleeding assessment during surgical intervention
timeFrame: Intraoperative
measure: Post operation infection
timeFrame: detected during the first six weeks of surgery
measure: Postoperative pain scores
timeFrame: During the first seven days after the surgical intervention
measure: The use of analgetic drugs for postoperative pain
timeFrame: During the first week after the surgical intervention
measure: Intra- Operative Complications
timeFrame: Intraoperative
measure: Postoperative Complications
timeFrame: During the first six weeks after the surgical intervention
measure: Vaginal Pain During Sexual Intercourse at Three Months
timeFrame: At 3 months after the surgical intervention
measure: Patient satisfaction from the surgical procedure
timeFrame: At 3 months after the surgical intervention
measure: Hospital Readmission
timeFrame: During the first six weeks after the surgical intervention
Other outcomes:
Locations:
city: Afula
country: Israel
facility: Haemek Medical Center
Study officials:
affiliation: haemek medical center
name: meirav braverman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: haemek medical center
name: Sivan Witzman
role: STUDY_DIRECTOR
affiliation: haemek medical center
name: eyal rom, MD
role: PRINCIPAL_INVESTIGATOR
References: