Clinical trial NCT04012710: vNOTES for Salpingo-oophorectomy
Official title: Transvaginal Natural Orifice Transluminal Endoscopic Surgery- A New Approach to Salpingo-oophorectomy
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Surgery
Keywords: Transvaginal natural orifice transluminal endoscopic surgery
Salpingo-oophorectomy
Laparoscopy
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
Collaborators: name: Assuta Medical Center
First posted: 2019-07-09
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The aim of this study is to compare the common approach of laparoscopy for bilateral salpingo - oophorectomy to a new approach via transvaginal natural orifice transluminal endoscopic surgery (vNOTES).

Detailed description: Natural Orifice Transluminal Endoscopic Surgery (NOTES) is an emerging field in minimally invasive surgery. NOTES can be performed via a variety of approaches, including through the stomach, esophagus, bladder, and rectum, but the majority of cases have been performed transvaginally (vNOTES).

The vNOTES technique includes conventional, laparoscopic instruments that are inserted through a single-port device that enables the insertion of 1 10-mm trocar, and 4 5-mm trocars. The operation in carried out placing the patient in the lithotomy position. After completing general anaesthesia, a 2.5-cm posterior colpotomy is made. The pouch of Douglas is opened and the transvaginal natural orifice transluminal endoscopic surgery (vNOTES) port is inserted transvaginally. A pneumoperitoneum is created, and the pelvic cavity, including the uterus and the adnexa is demonstrated. Only then, the conventional laparoscopic instruments are inserted.

By incorporating the advantages of endoscopic surgery, the vNOTES approach avoids abdominal wall wounds and trocar-related complications, including reducing post operation pain. Moreover, recent studies report, shorter hospital stay, improved visibility, and the possibility to circumvent extensive lysis of adhesion to reach the pelvic cavity. It should be mentioned that operative risks such as : anesthesia complications, excessive blood loss, damage to near organs ( intestines or bladder), and vasculature damage exists in both conventional laparoscopy and vNOTES approach.

vNOTES technique has been used for hysterectomy and was proven to be just as good as laparoscopy with the advantage of daycare surgery. The use of vNOTES for salpingo-oophorectomy without concomitant hysterectomy has been questioned due to challenging accessibility. To the best of our knowledge, data concerning the experience using this technique for salpingo-oophorectomy is scarce and based on few published case-reports.

Therefore, the aim of this study is to compare the common approach of laparoscopy for bilateral salpingo - oophorectomy to a new approach via transvaginal natural orifice transluminal endoscopic surgery (vNOTES).

Material and methods

This is a randomized prospective study including women admitted electively to a single care center for bilateral salpingo-oophorectomy due to benign indication. Women that will be found to fit inclusion criteria will get by the research team explanation on both techniques. After giving informed consent, all women will be allocated to one of two operative techniques by en-block randomization:

1. Laparoscopy
2. vNOTES

Both operations will be done by a single highly skilled operator. All women will sign informed consent before admitted to operation room. Patient's demographics, characteristics, perioperative, operative and post-operative data will be collected from medical records. Data will be coded in order to save confidentiality ( each serial number will identify a patient. The list of serial numbers that fits each identification number will be available only for the principle investigator ).

Eligibility criteria: Inclusion Criteria:

* Elective surgery
* Benign indication for surgery

Exclusion Criteria:

* Severe endometriosis
* Past pelvic operations
* Suspected malignancy
* Combined planned hysterectomy
* Recurrent Pelvic Inflammatory disease (PID)
* Vaginal anomaly

Primary outcomes:
measure: Intra - Operative complication rate
timeFrame: Intra - Operative
Secondary outcomes:
measure: Woman satisfaction rate post operation
timeFrame: Estimated on post operation day -1- through study completion, an average of 1 year
Other outcomes:
Locations:
city: Ramat -Gan
country: Israel
facility: Aya Mohr Sasson
state: Please Select
Study officials:
affiliation: Assuta Medical Center, Israel
name: Aya Mohr-Sasson
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jallad K, Walters MD. Natural Orifice Transluminal Endoscopic Surgery (NOTES) in Gynecology. Clin Obstet Gynecol. 2017 Jun;60(2):324-329. doi: 10.1097/GRF.0000000000000280.
citation: Tantitamit T, Lee CL. Application of Sentinel Lymph Node Technique to Transvaginal Natural Orifices Transluminal Endoscopic Surgery in Endometrial Cancer. J Minim Invasive Gynecol. 2019 Jul-Aug;26(5):949-953. doi: 10.1016/j.jmig.2018.10.001. Epub 2018 Oct 5.
citation: Boesen L, Meisner S, Vilmann P, Jorgensen LN, Rosenberg J, Donatsky AM. [Transvaginal hybrid natural orifice transluminal endoscopic surgery cholecystectomy]. Ugeskr Laeger. 2016 Jan 25;178(4):V06150482. Danish.
citation: Hiep PN, Thien HH, Vu PA, Thanh PH, Xuan NT. Natural orifice transluminal endoscopic surgery for colorectal cancer. BJS Open. 2017 May 24;1(1):24-29. doi: 10.1002/bjs5.4. eCollection 2017 Feb.
citation: Baekelandt J. Transvaginal natural orifice transluminal endoscopic surgery: a new approach to ovarian cystectomy. Fertil Steril. 2018 Feb;109(2):366. doi: 10.1016/j.fertnstert.2017.10.037. Epub 2017 Dec 13.
citation: Baekelandt J, De Mulder PA, Le Roy I, Mathieu C, Laenen A, Enzlin P, Weyers S, Mol BW, Bosteels JJ. Postoperative outcomes and quality of life following hysterectomy by natural orifice transluminal endoscopic surgery (NOTES) compared to laparoscopy in women with a non-prolapsed uterus and benign gynaecological disease: a systematic review and meta-analysis. Eur J Obstet Gynecol Reprod Biol. 2017 Jan;208:6-15. doi: 10.1016/j.ejogrb.2016.10.044. Epub 2016 Oct 29.
citation: Baekelandt JF, De Mulder PA, Le Roy I, Mathieu C, Laenen A, Enzlin P, Weyers S, Mol B, Bosteels J. Hysterectomy by transvaginal natural orifice transluminal endoscopic surgery versus laparoscopy as a day-care procedure: a randomised controlled trial. BJOG. 2019 Jan;126(1):105-113. doi: 10.1111/1471-0528.15504.
citation: Baekelandt JF, De Mulder PA, Le Roy I, Mathieu C, Laenen A, Enzlin P, Weyers S, Mol BWJ, Bosteels JJA. Transvaginal natural orifice transluminal endoscopic surgery (vNOTES) adnexectomy for benign pathology compared with laparoscopic excision (NOTABLE): a protocol for a randomised controlled trial. BMJ Open. 2018 Jan 10;8(1):e018059. doi: 10.1136/bmjopen-2017-018059.
citation: Terzi H, Turkay U, Uzun ND, Salici M. Hysterectomy and salpingo-oophorectomy by transvaginal natural orifice transluminal endoscopic surgery (V-NOTES) assisted by an umbilical camera: Case report and new hybrid technique in gynecology. Int J Surg Case Rep. 2018;51:349-351. doi: 10.1016/j.ijscr.2018.08.053. Epub 2018 Sep 5.