4006-776-356 出国就医服务电话

免费获得国外相关药品，最快 1 个工作日回馈药物信息

出境医 / 临床实验 / vNOTES for Salpingo-oophorectomy

vNOTES for Salpingo-oophorectomy

Study Description
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).

Condition or disease Intervention/treatment Phase
Surgery Procedure: Laparoscopy Procedure: vNOTES Not Applicable

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 ).

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Transvaginal Natural Orifice Transluminal Endoscopic Surgery- A New Approach to Salpingo-oophorectomy
Estimated Study Start Date : July 2020
Estimated Primary Completion Date : July 1, 2021
Estimated Study Completion Date : July 1, 2021
Arms and Interventions
Arm Intervention/treatment
Active Comparator: Laparoscopy
Abdominal conventional laparoscopy for salpingo-oophorectomy
 Procedure: Laparoscopy
Conventional abdominal laparoscopy
Active Comparator: vNOTES
Transvaginal natural orifice transluminal endoscopic surgery for salpingo-oophorectomy
 Procedure: vNOTES
Transvaginal natural orifice transluminal endoscopic surgery for salpingo-oophorectomy
Outcome Measures
Primary Outcome Measures :
  1. Intra - Operative complication rate [ Time Frame: Intra - Operative ]
    Complications during operation as a compound outcome including - bleeding. damage to neer organs and vasculature damage


Secondary Outcome Measures :
  1. Woman satisfaction rate post operation [ Time Frame: Estimated on post operation day -1- through study completion, an average of 1 year ]
    Satisfaction rate estimated by VAS -Visual Analogue Scale - A numeric satisfactory rating scale scoring 0 to 10, while 0 is not satisfied at all and 10 is highly satisfied .


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:  

Only women planned to undergo bilateral salpingo-oophorectomy

.
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Aya Mohr-Sasson, M.D 0523692906 mohraya@gmail.com

Locations
Layout table for location information
Israel
Aya Mohr Sasson Recruiting
Ramat -Gan, Please Select, Israel, 52621
Contact: Aya Mohr Sasson    523692906    mohraya@gmail.com   
Sponsors and Collaborators
Sheba Medical Center
Assuta Medical Center
Investigators
Layout table for investigator information
Principal Investigator: Aya Mohr-Sasson Assuta Medical Center, Israel
Tracking Information
First Submitted Date  ICMJE July 7, 2019
First Posted Date  ICMJE July 9, 2019
Last Update Posted Date July 12, 2019
Estimated Study Start Date  ICMJE July 2020
Estimated Primary Completion Date July 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 8, 2019) 		Intra - Operative complication rate [ Time Frame: Intra - Operative ]
Complications during operation as a compound outcome including - bleeding. damage to neer organs and vasculature damage
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 11, 2019) 		Woman satisfaction rate post operation [ Time Frame: Estimated on post operation day -1- through study completion, an average of 1 year ]
Satisfaction rate estimated by VAS -Visual Analogue Scale - A numeric satisfactory rating scale scoring 0 to 10, while 0 is not satisfied at all and 10 is highly satisfied .
Original Secondary Outcome Measures  ICMJE
 (submitted: July 8, 2019) 		Woman satisfaction rate post operation [ Time Frame: Estimated on post operation day -1- through study completion, an average of 1 year ]
Satisfaction rate estimated by VAS (visual analogue scale ) Scale
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE vNOTES for Salpingo-oophorectomy
Official Title  ICMJE Transvaginal Natural Orifice Transluminal Endoscopic Surgery- A New Approach to Salpingo-oophorectomy
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 ).
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Surgery
Intervention  ICMJE
  • Procedure: Laparoscopy
    Conventional abdominal laparoscopy
  • Procedure: vNOTES
    Transvaginal natural orifice transluminal endoscopic surgery for salpingo-oophorectomy
Study Arms  ICMJE
  • Active Comparator: Laparoscopy
    Abdominal conventional laparoscopy for salpingo-oophorectomy
    Intervention: Procedure: Laparoscopy
  • Active Comparator: vNOTES
    Transvaginal natural orifice transluminal endoscopic surgery for salpingo-oophorectomy
    Intervention: Procedure: vNOTES
Publications *
  • 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. Review.
  • 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.
  • Boesen L, Meisner S, Vilmann P, Jørgensen LN, Rosenberg J, Donatsky AM. [Transvaginal hybrid natural orifice transluminal endoscopic surgery cholecystectomy]. Ugeskr Laeger. 2016 Jan 25;178(4):V06150482. Review. Danish.
  • 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.
  • 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.
  • 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. Review.
  • 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.
  • 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.
  • Terzi H, Turkay U, Uzun ND, Salıcı 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 8, 2019) 		100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 1, 2021
Estimated Primary Completion Date July 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Gender Eligibility Description:

Only women planned to undergo bilateral salpingo-oophorectomy

.
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Aya Mohr-Sasson, M.D 0523692906 mohraya@gmail.com
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04012710
Other Study ID Numbers  ICMJE 32-19-ASMC
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Dr. Aya Mohr-Sasson, Sheba Medical Center
Study Sponsor  ICMJE Sheba Medical Center
Collaborators  ICMJE Assuta Medical Center
Investigators  ICMJE
Principal Investigator: Aya Mohr-Sasson Assuta Medical Center, Israel
PRS Account Sheba Medical Center
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

治疗医院

新药特效药

治疗案例

前沿医讯