vNOTES for Salpingo-oophorectomy

NCT04012710 | Not Yet Recruiting

• 1 other identifier: 32-19-ASMC
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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).

Conditions

Surgery

Keywords

Transvaginal natural orifice transluminal endoscopic surgery; Salpingo-oophorectomy; Laparoscopy

Outcome Measures

Primary Outcomes (1)

• Intra - Operative complication rate

  Complications during operation as a compound outcome including - bleeding. damage to neer organs and vasculature damage

  Intra - Operative

Secondary Outcomes (1)

• Woman satisfaction rate post operation

  Estimated on post operation day -1- through study completion, an average of 1 year

Study Arms (2)

Laparoscopy

ACTIVE COMPARATOR

Abdominal conventional laparoscopy for salpingo-oophorectomy

Procedure: Laparoscopy

vNOTES

ACTIVE COMPARATOR

Transvaginal natural orifice transluminal endoscopic surgery for salpingo-oophorectomy

Procedure: vNOTES

Interventions

Laparoscopy PROCEDURE

Conventional abdominal laparoscopy

Laparoscopy

vNOTES PROCEDURE

Transvaginal natural orifice transluminal endoscopic surgery for salpingo-oophorectomy

vNOTES

Eligibility Criteria

• Age: 18 Years - 80 Years
• Gender Eligibility Details: Only women planned to undergo bilateral salpingo-oophorectomy .
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Elective surgery
• Benign indication for surgery

You may not qualify if:

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

Sponsors & Collaborators

• Sheba Medical Center: lead
• Assuta Medical Center: collaborator

Study Sites (1)

Aya Mohr Sasson

Ramat Gan, Please Select, 52621, Israel

Location

Related Publications (9)

• 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.

  PMID: 28221179 RESULT

• 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.

  PMID: 30296476 RESULT

• 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.

  PMID: 26815719 RESULT

• 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.

  PMID: 29951602 RESULT

• 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.

  PMID: 29246560 RESULT

• 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.

  PMID: 27880893 RESULT

• 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.

  PMID: 30325565 RESULT

• 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.

  PMID: 29326183 RESULT

• 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.

  PMID: 30248628 RESULT

MeSH Terms

Interventions

Laparoscopy

Intervention Hierarchy (Ancestors)

Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Aya Mohr-Sasson

  Assuta Medical Center, Israel

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aya Mohr-Sasson, M.D

CONTACT

0523692906; mohraya@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: July 7, 2019
• First Posted: July 9, 2019
• Study Start: July 3, 2025
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: November 14, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)