SurgeryNCT04012710
vNOTES for Salpingo-oophorectomy
A study testing Laparoscopy and vNOTES in people with Surgery, run by Sheba Medical Center at 1 site in Israel.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Surgery
- What is being tested?
- Laparoscopy and vNOTES
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- 3 Jul 2025to 1 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Elective surgery
- Benign indication for surgery
Who cannot join
- Severe endometriosis
- Past pelvic operations
- Suspected malignancy
- Combined planned hysterectomy
- Recurrent Pelvic Inflammatory disease (PID)
- Vaginal anomaly
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Israel1 site
Aya Mohr Sasson
Ramat Gan, Please Select, 52621
Aya Mohr Sasson, 523692906, mohraya@gmail.com
About this study
Official title: Transvaginal Natural Orifice Transluminal Endoscopic Surgery- A New Approach to Salpingo-oophorectomy
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).
Read the 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:
- Laparoscopy
- 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 ).
- Conditions
- Surgery
- Being tested
- Laparoscopy, vNOTES
- Keywords
- Transvaginal natural orifice transluminal endoscopic surgery, Salpingo-oophorectomy, Laparoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LaparoscopyProcedure or surgery
Conventional abdominal laparoscopy
vNOTESProcedure or surgery
Transvaginal natural orifice transluminal endoscopic surgery for salpingo-oophorectomy
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopy | Active comparator | Abdominal conventional laparoscopy for salpingo-oophorectomy Receives: Procedure: Laparoscopy |
| vNOTES | Active comparator | Transvaginal natural orifice transluminal endoscopic surgery for salpingo-oophorectomy Receives: Procedure: vNOTES |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intra - Operative complication rate
Complications during operation as a compound outcome including - bleeding. damage to neer organs and vasculature damage
Measured: Intra - Operative
Secondary outcomes (1)
Woman satisfaction rate post operation
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 .
Measured: Estimated on post operation day -1- through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2019
- Study start3 Jul 2025 (estimated)
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Collaborators
- Assuta Medical Center
- Responsible party
- Principal investigator, Dr. Aya Mohr-Sasson, Sheba Medical Center
- Investigators
- Aya Mohr-Sasson, Principal investigator, Assuta Medical Center, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04012710
- Sponsor's protocol ID
- 32-19-ASMC
- Status last verified
- Nov 2024
- First submitted
- 7 Jul 2019
- Last updated
- 14 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 28221179Tantitamit 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.
PubMed 30296476Boesen 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.
PubMed 26815719Hiep 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.
PubMed 29951602Baekelandt 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.
PubMed 29246560Baekelandt 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.
PubMed 27880893Baekelandt 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.
PubMed 30325565Baekelandt 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.
PubMed 29326183Terzi 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.
PubMed 30248628
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transvaginal Natural Orifice Transluminal Endoscopic Surgery- A New Approach to Salpingo-oophorectomy
- ClinicalTrials.gov ID
- NCT04012710
- Acronym / sponsor ID
- 32-19-ASMC
- Conditions
- Surgery
- Keywords
- Transvaginal natural orifice transluminal endoscopic surgery, Salpingo-oophorectomy, Laparoscopy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Collaborators
- Assuta Medical Center
- Study start
- 3 Jul 2025 (estimated)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 9 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Laparoscopy
- 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
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laparoscopy | Active comparator | Procedure: LaparoscopyAbdominal conventional laparoscopy for salpingo-oophorectomy |
| vNOTES | Active comparator | Procedure: vNOTESTransvaginal natural orifice transluminal endoscopic surgery for salpingo-oophorectomy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Elective surgery
- Benign indication for surgery
Key exclusion criteria (6 listed)
- Severe endometriosis
- Past pelvic operations
- Suspected malignancy
- Combined planned hysterectomy
- Recurrent Pelvic Inflammatory disease (PID)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LaparoscopyConventional abdominal laparoscopy | Procedure or surgery | Laparoscopy |
| vNOTESTransvaginal natural orifice transluminal endoscopic surgery for salpingo-oophorectomy | Procedure or surgery | vNOTES |
Primary outcome
Intra - Operative complication rate
Time frame: Intra - Operative
Complications during operation as a compound outcome including - bleeding. damage to neer organs and vasculature damage
1 secondary outcome
Woman satisfaction rate post operation
Time frame: Estimated on post operation day -1- through study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2024.
- Results publication: PubMed 28221179Jallad 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.
- Results publication: PubMed 30296476Tantitamit 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.
- Results publication: PubMed 26815719Boesen 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.
- Results publication: PubMed 29951602Hiep 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.
- Results publication: PubMed 29246560Baekelandt 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.
- Results publication: PubMed 27880893Baekelandt 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.
- Results publication: PubMed 30325565Baekelandt 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.
- Results publication: PubMed 29326183Baekelandt 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.
- Results publication: PubMed 30248628Terzi 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Aya Mohr-Sasson principal investigator
Assuta Medical Center, Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopy and vNOTES in people with Surgery, run by Sheba Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 14 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aya Mohr-Sasson, M.D (0523692906, mohraya@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intra - Operative complication rate (time frame: Intra - Operative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04012710, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2024.