SurgeryPUP-VNOTESNCT05623514
Ultrasound Evaluation for Improving Patient Selection in vNOTES
An observational study of Surgery, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
Vaginal Natural Orifice Transluminal Endoscopic Surgery (vNOTES) is an emerging field in minimally invasive surgery. An international consensus-based statement was recently published to help guide the basis for adopting vNOTES into clinical practice, including regarding patient selection. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Surgery
- What is being tested?
- Trans-vaginal ultrasound
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 16 May 2022to Dec 2027
- Phase
- Observational
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Women who are patients at UT Physicians gynecological clinics, are planned to undergo benign gynecological surgery (hysterectomy or adnexectomy) with normal vaginal examination (normal mobility of the uterus), and are considered for the vNOTES surgical approach.
Who may be able to join
- -Women planned to undergo surgery for hysterectomy or adnexal indication with normal vaginal examination, that are considered for vNOTES approach.
Who cannot join
- History of radiation to the pelvis
- Malignancy
- Combined current vaginal operation (for the treatment of prolapse/ urinary complaints)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Texas
Houston, Texas, 77030
Aya Mohr-Sasson, M.D, 346-270-4682, aya.mohrsasson@uth.tmc.edu
Sunbola Ashimi, sunbola.s.ashimi@uth.tmc.edu
About this study
Official title: Pre-surgical Ultrasound Evaluation for Improving Patient Selection for vNOTES Approach
Vaginal Natural Orifice Transluminal Endoscopic Surgery (vNOTES) is an emerging field in minimally invasive surgery. An international consensus-based statement was recently published to help guide the basis for adopting vNOTES into clinical practice, including regarding patient selection. It was agreed that women with potential adhesions are not appropriate candidates for vNOTES approach including women with suspected adhesions due to history of severe pelvic inflammatory disease (PID) or endometriosis. However, as some pelvic infections might be asymptomatic, pre-operation imaging might be beneficial to complete improved selection of patients. Moreover, women with previous severe PID or endometriosis might still have favorable pelvic characteristics to perform the vNOTES approach. Therefore, we aim to compare pre-operation ultrasound evaluation to operative characteristics and outcomes in women undergoing VNOTES approach surgery. Douglas space characteristics, as assessed by ultrasound evaluation of sliding sign, of the patients undergoing vNOTES approach surgery will be compared to patients that were ruled from vNOTES approach in order to evaluate the association of the presence or absence of sliding sign on pre-operation ultrasound to the clinical findings.
Read the detailed description
Vaginal Natural Orifice Transluminal Endoscopic Surgery (vNOTES) is an emerging field in minimally invasive surgery. It has gained the most popularity compared to other transluminal natural orifices such as mouth, rectum or urinary tract. By incorporating the advantages of endoscopic surgery, the vNOTES approach avoids abdominal wall wounds and trocar-related complications. Recent studies report reduced postoperative pain, accelerated postoperative recovery, and decreased postoperative wound infections, as well as achieving highly satisfying cosmetic results. All these made this technique very appealing to surgeons and patients alike.
The feasibility and safety of vNOTES in gynecologic surgeries was first introduced by Ahn et al. in 2012 that performed vNOTES in ten women with benign uterine adnexal disease. Since then, surgeons have developed the technique in various benign gynecologic surgeries indications. There has been an exponential uptake of the number of surgeons performing vNOTES procedures worldwide with no official guidance to ensure the safe implementation of this technique into gynecological practice. The novelty of the technique is still a matter of concern in sub-populations and different indications.
International consensus-based statement was recently published based on Delphi consensus of expert panel to help guide the basis for adopting vNOTES into clinical practice with respect to eight key domains including patient selection. It was agreed that women with potential adhesions are not appropriate candidates for vNOTES approach including women with a history of a severe PID that is considered contraindication. 97.4% of the experts agreed that it is not necessary to perform a preoperative vaginal culture if the patient is asymptomatic. However, as some pelvic infections might be asymptomatic, such as with chlamydia, pre-operation imaging might be beneficial to complete proper patient selection for the vNOTES approach. Moreover, women with previous severe PID infection might still have favorable pelvic characteristics to perform the vNOTES approach.
Aim: To the best of our knowledge no guidelines have been published regarding the pre-operation evaluation and the imaging characteristics. Due to the aforementioned, the aim of our study is to compare pre-operation ultrasound evaluation to operative characteristics and outcomes. Douglas space characteristics, as assessed by ultrasound evaluation of sliding sign, of the patients undergoing vNOTES approach surgery will be compared to patients that were ruled from vNOTES approach in order to evaluate the association of the presence or absence of sliding sign on pre-operation ultrasound to the clinical findings.
Clinical Procedures:
As part of the evaluation at the pre-operation clinics, women will complete vaginal examination to assess for pelvic organs mobility and potential adhesions.
Trans-vaginal examination will be completed to evaluate uterus and adnexal characteristics in addition to sliding sign between the uterus to the rectum for the evaluation of the Douglas space.
Women with normal ultrasound evaluation and a positive sliding sign will continue with surgery via the vNOTES approach. Women with limited mobility demonstrated on ultrasound will be recommended alternative surgical approaches.
Swabs will be collected for potential PID pathogens including chlamydia, gonorrhea, trichomonas and mycoplasma.
The operation report will include information regarding pelvic adhesions, location of the adhesions and abdominal screening (Including diaphragm and liver area). For patients undergoing vNOTES approach surgery - difficulty to complete anterior or posterior colpotomy will be documented.
- Conditions
- Surgery
- Being tested
- Trans-vaginal ultrasound
- Keywords
- vaginal surgery, trans-vaginal ultrasound examination, sliding sign
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trans-vaginal ultrasoundDiagnostic test
Pre-operative trans-vaginal ultrasound in order to evaluate sliding sign between the uterus and the rectum for the evaluation of the Douglas space
| Study group | Role | What they receive |
|---|---|---|
| Candidates for the vaginal natural orifice trans-luminal surgery (vNOTES) approach | Candidates for benign gynecological surgery in the vaginal natural orifice trans-luminal surgery (vNOTES) approach Receives: Diagnostic Test: Trans-vaginal ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of adhesions/complicated entry to the Douglas space reported during surgery
Measured: From recruitment in the clinics until one month post-operation
Secondary outcomes (3)
Operative complication rate
Operative complications include organ damage (damage caused during the surgery to the bladder, the rectum or blood vessel), bleeding, and vascular damage.
Measured: during the operation
Post-operative complication rate
Post-operative complications include surgical site infection (SSI), dyspareunia, vaginal bleeding, re-hospitalization, and pain.
Measured: from operation until one month post-operation
Operation time
Measured: during the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2022
- Study start16 May 2022
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Texas Health Science Center, Houston
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aya Mohr Sasson, The University of Texas Health Science Center, Houston
- Investigators
- Aya Mohr-Sasson, Principal investigator, The University of Texas Health Science Center, Houston, TX
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05623514
- Sponsor's protocol ID
- HSC-MS-22-0947
- Acronym
- PUP-VNOTES
- Status last verified
- Sep 2026
- First submitted
- 10 Nov 2022
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
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 28221179Li CB, Hua KQ. Transvaginal natural orifice transluminal endoscopic surgery (vNOTES) in gynecologic surgeries: A systematic review. Asian J Surg. 2020 Jan;43(1):44-51. doi: 10.1016/j.asjsur.2019.07.014. Epub 2019 Aug 20.
PubMed 31444108Baekelandt 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 27880893Coomber RS, Sodergren MH, Clark J, Teare J, Yang GZ, Darzi A. Natural orifice translumenal endoscopic surgery applications in clinical practice. World J Gastrointest Endosc. 2012 Mar 16;4(3):65-74. doi: 10.4253/wjge.v4.i3.65.
PubMed 22442743Ahn KH, Song JY, Kim SH, Lee KW, Kim T. Transvaginal single-port natural orifice transluminal endoscopic surgery for benign uterine adnexal pathologies. J Minim Invasive Gynecol. 2012 Sep-Oct;19(5):631-5. doi: 10.1016/j.jmig.2012.04.001. Epub 2012 Jul 3.
PubMed 22763314Kapurubandara S, Lowenstein L, Salvay H, Herijgers A, King J, Baekelandt J. Consensus on safe implementation of vaginal natural orifice transluminal endoscopic surgery (vNOTES). Eur J Obstet Gynecol Reprod Biol. 2021 Aug;263:216-222. doi: 10.1016/j.ejogrb.2021.06.019. Epub 2021 Jun 17.
PubMed 34237485
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pre-surgical Ultrasound Evaluation for Improving Patient Selection for vNOTES Approach
- ClinicalTrials.gov ID
- NCT05623514
- Acronym / sponsor ID
- PUP-VNOTES / HSC-MS-22-0947
- Conditions
- Surgery
- Keywords
- vaginal surgery, trans-vaginal ultrasound examination, sliding sign
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- 16 May 2022 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 21 Nov 2022 (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.
Vaginal Natural Orifice Transluminal Endoscopic Surgery (vNOTES) is an emerging field in minimally invasive surgery. An international consensus-based statement was recently published to help guide the basis for adopting vNOTES into clinical practice, including regarding patient selection. It was agreed that women with potential adhesions are not appropriate candidates for vNOTES approach including women with suspected adhesions due to history of severe pelvic inflammatory disease (PID) or endometriosis. However, as some pelvic infections might be asymptomatic, pre-operation imaging might be beneficial to complete improved selection of patients. Moreover, women with previous severe PID or endometriosis might still have favorable pelvic characteristics to perform the vNOTES approach. Therefore, we aim to compare pre-operation ultrasound evaluation to operative characteristics and outcomes in women undergoing VNOTES approach surgery. Douglas space characteristics, as assessed by ultrasound evaluation of sliding sign, of the patients undergoing vNOTES approach surgery will be compared to patients that were ruled from vNOTES approach in order to evaluate the association of the presence or absence of sliding sign on pre-operation ultrasound to the clinical findings.
Detailed description
Vaginal Natural Orifice Transluminal Endoscopic Surgery (vNOTES) is an emerging field in minimally invasive surgery. It has gained the most popularity compared to other transluminal natural orifices such as mouth, rectum or urinary tract. By incorporating the advantages of endoscopic surgery, the vNOTES approach avoids abdominal wall wounds and trocar-related complications. Recent studies report reduced postoperative pain, accelerated postoperative recovery, and decreased postoperative wound infections, as well as achieving highly satisfying cosmetic results. All these made this technique very appealing to surgeons and patients alike.
The feasibility and safety of vNOTES in gynecologic surgeries was first introduced by Ahn et al. in 2012 that performed vNOTES in ten women with benign uterine adnexal disease. Since then, surgeons have developed the technique in various benign gynecologic surgeries indications. There has been an exponential uptake of the number of surgeons performing vNOTES procedures worldwide with no official guidance to ensure the safe implementation of this technique into gynecological practice. The novelty of the technique is still a matter of concern in sub-populations and different indications.
International consensus-based statement was recently published based on Delphi consensus of expert panel to help guide the basis for adopting vNOTES into clinical practice with respect to eight key domains including patient selection. It was agreed that women with potential adhesions are not appropriate candidates for vNOTES approach including women with a history of a severe PID that is considered contraindication. 97.4% of the experts agreed that it is not necessary to perform a preoperative vaginal culture if the patient is asymptomatic. However, as some pelvic infections might be asymptomatic, such as with chlamydia, pre-operation imaging might be beneficial to complete proper patient selection for the vNOTES approach. Moreover, women with previous severe PID infection might still have favorable pelvic characteristics to perform the vNOTES approach.
Aim: To the best of our knowledge no guidelines have been published regarding the pre-operation evaluation and the imaging characteristics. Due to the aforementioned, the aim of our study is to compare pre-operation ultrasound evaluation to operative characteristics and outcomes. Douglas space characteristics, as assessed by ultrasound evaluation of sliding sign, of the patients undergoing vNOTES approach surgery will be compared to patients that were ruled from vNOTES approach in order to evaluate the association of the presence or absence of sliding sign on pre-operation ultrasound to the clinical findings.
Clinical Procedures:
As part of the evaluation at the pre-operation clinics, women will complete vaginal examination to assess for pelvic organs mobility and potential adhesions.
Trans-vaginal examination will be completed to evaluate uterus and adnexal characteristics in addition to sliding sign between the uterus to the rectum for the evaluation of the Douglas space.
Women with normal ultrasound evaluation and a positive sliding sign will continue with surgery via the vNOTES approach. Women with limited mobility demonstrated on ultrasound will be recommended alternative surgical approaches.
Swabs will be collected for potential PID pathogens including chlamydia, gonorrhea, trichomonas and mycoplasma.
The operation report will include information regarding pelvic adhesions, location of the adhesions and abdominal screening (Including diaphragm and liver area). For patients undergoing vNOTES approach surgery - difficulty to complete anterior or posterior colpotomy will be documented.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Candidates for the vaginal natural orifice trans-luminal surgery (vNOTES) approach | – | Diagnostic Test: Trans-vaginal ultrasoundCandidates for benign gynecological surgery in the vaginal natural orifice trans-luminal surgery (vNOTES) approach |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Women who are patients at UT Physicians gynecological clinics, are planned to undergo benign gynecological surgery (hysterectomy or adnexectomy) with normal vaginal examination (normal mobility of the uterus), and are considered for the vNOTES surgical approach.
Key inclusion criteria (1 listed)
- -Women planned to undergo surgery for hysterectomy or adnexal indication with normal vaginal examination, that are considered for vNOTES approach.
Key exclusion criteria (3 listed)
- History of radiation to the pelvis
- Malignancy
- Combined current vaginal operation (for the treatment of prolapse/ urinary complaints)
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 |
|---|---|---|
| Trans-vaginal ultrasoundPre-operative trans-vaginal ultrasound in order to evaluate sliding sign between the uterus and the rectum for the evaluation of the Douglas space | Diagnostic test | Candidates for the vaginal natural orifice trans-luminal surgery (vNOTES) approach |
Primary outcome
The rate of adhesions/complicated entry to the Douglas space reported during surgery
Time frame: From recruitment in the clinics until one month post-operation
3 secondary outcomes
Operative complication rate
Time frame: during the operation
Post-operative complication rate
Time frame: from operation until one month post-operation
Operation time
Time frame: during the operation
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 1 Oct 2026.
- Background: 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.
- Background: PubMed 31444108Li CB, Hua KQ. Transvaginal natural orifice transluminal endoscopic surgery (vNOTES) in gynecologic surgeries: A systematic review. Asian J Surg. 2020 Jan;43(1):44-51. doi: 10.1016/j.asjsur.2019.07.014. Epub 2019 Aug 20.
- Background: 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.
- Background: PubMed 22442743Coomber RS, Sodergren MH, Clark J, Teare J, Yang GZ, Darzi A. Natural orifice translumenal endoscopic surgery applications in clinical practice. World J Gastrointest Endosc. 2012 Mar 16;4(3):65-74. doi: 10.4253/wjge.v4.i3.65.
- Background: PubMed 22763314Ahn KH, Song JY, Kim SH, Lee KW, Kim T. Transvaginal single-port natural orifice transluminal endoscopic surgery for benign uterine adnexal pathologies. J Minim Invasive Gynecol. 2012 Sep-Oct;19(5):631-5. doi: 10.1016/j.jmig.2012.04.001. Epub 2012 Jul 3.
- Background: PubMed 34237485Kapurubandara S, Lowenstein L, Salvay H, Herijgers A, King J, Baekelandt J. Consensus on safe implementation of vaginal natural orifice transluminal endoscopic surgery (vNOTES). Eur J Obstet Gynecol Reprod Biol. 2021 Aug;263:216-222. doi: 10.1016/j.ejogrb.2021.06.019. Epub 2021 Jun 17.
- Individual participant dataSharing planned: Undecided
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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
The University of Texas Health Science Center, Houston, TX
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Surgery, run by The University of Texas Health Science Center, Houston at 1 site in United States.
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 1 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 1 Oct 2026. 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 United States. 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 (13462704682, aya.mohrsasson@uth.tmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of adhesions/complicated entry to the Douglas space reported during surgery (time frame: From recruitment in the clinics until one month post-operation). 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 NCT05623514, which also lists 6 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 1 Oct 2026.