Ultrasound Evaluation for Surgery Selection

(PUP-VNOTES Trial)

Overseen By Aya Mohr-Sasson, M.D

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: The University of Texas Health Science Center, Houston

Disqualifiers: Pelvic radiation, Malignancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

75 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how ultrasound can assist doctors in determining if a new, less invasive surgery called vNOTES suits certain women. It focuses on those with potential pelvic issues from past infections or conditions like severe pelvic inflammatory disease (PID) or endometriosis. Women planning surgery for conditions such as a hysterectomy, who have been offered vNOTES as an option, might be suitable candidates. The trial aims to assess whether using trans-vaginal ultrasound (TVUS) before surgery can improve outcomes and help doctors select the best candidates for this approach. As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research that could enhance surgical decision-making and outcomes for women.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. Please consult with the trial coordinators or your doctor for guidance.

What prior data suggests that trans-vaginal ultrasound is safe for evaluating surgery candidates?

Research has shown that using a trans-vaginal ultrasound in vNOTES surgery is generally safe. Studies have found that this method improves health outcomes one month and six months post-surgery.

Research involving 550 patients suggested that this surgical approach is safe and effective for most women needing gynecological surgery for non-cancerous conditions. This indicates that using a trans-vaginal ultrasound in this context is well-tolerated and poses no major safety concerns.

Overall, the evidence suggests that this treatment is safe for most patients when used for these types of surgeries. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using trans-vaginal ultrasound for surgery selection because it offers a non-invasive way to evaluate candidates for vaginal natural orifice trans-luminal surgery. This method could potentially reduce the need for more invasive procedures like laparoscopy or open surgery, which are typically used to assess surgical candidates. By providing detailed images through this ultrasound approach, doctors can make more informed decisions about who is suitable for surgery, potentially improving outcomes and reducing recovery time for patients undergoing benign gynecological surgeries.

What evidence suggests that trans-vaginal ultrasound is effective for selecting candidates for vNOTES surgery?

Research shows that vaginal natural orifice transluminal endoscopic surgery (vNOTES) is a promising type of minimally invasive surgery. Studies have found that vNOTES can lead to less post-operative pain, quicker recovery, and no visible scars compared to traditional surgeries. Patients often regain digestive function faster and spend less time in the hospital. Although vNOTES is generally effective, it may not suit women with severe pelvic inflammatory disease (PID) or endometriosis due to potential internal scarring. In this trial, pre-surgery imaging, such as a trans-vaginal ultrasound, will help determine if a patient is a good candidate for this surgery. ^{6 7 8 9 10}

Who Is on the Research Team?

Aya Mohr-Sasson

Principal Investigator

The University of Texas Health Science Center, Houston, TX

Are You a Good Fit for This Trial?

This trial is for women who are scheduled to have a hysterectomy or surgery on the ovaries/fallopian tubes and are candidates for vNOTES, a less invasive surgical technique. They should have normal vaginal exams but no history of pelvic radiation, cancer, or current surgeries for prolapse or urinary issues.

Inclusion Criteria

I am a woman planning surgery for a hysterectomy or related reason and am considered for a less invasive approach.

Exclusion Criteria

I have had cancer before.

I have had radiation treatment to my pelvic area.

I am undergoing a vaginal surgery for prolapse or urinary issues.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Pre-operation Evaluation

Pre-operation ultrasound evaluation to assess pelvic organs mobility and potential adhesions

1-2 weeks

1 visit (in-person)

Surgery

Participants undergo vNOTES approach surgery if eligible based on pre-operation evaluation

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after surgery, including assessment of post-operative complications

4 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Trans-vaginal ultrasound

Trial Overview The study tests if using trans-vaginal ultrasound before surgery can help doctors decide better who's fit for vNOTES—a minimally invasive procedure done through the vagina—especially in patients with past infections or endometriosis.

How Is the Trial Designed?

Group I: Candidates for vaginal natural orifice trans-luminal surgery approach Experimental Treatment 1 Intervention

Candidates for benign gynecological surgery in the vaginal natural orifice trans-luminal surgery approach

Who Is Running the Clinical Trial?

The University of Texas Health Science Center, Houston

Lead Sponsor

Trials

974

Recruited

361,000+

Published Research Related to This Trial

Transvaginal ultrasound (TVUS) and MRI both showed high sensitivity (83.3%) for detecting adnexal lesions, but MRI had significantly higher specificity (92.9% vs. 73.2% for TVUS), making it a more reliable diagnostic tool.

The study involved 227 patients and found that MRI was able to correctly reclassify 51 lesions initially assessed by TVUS, indicating that MRI should be used as a second-line technique for lesions rated O-RADS 4 and 5.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

O-RADS scoring system for adnexal lesions: Diagnostic performance on TVUS performed by an expert sonographer and MRI. Campos, A., Villermain-Lécolier, C., Sadowski, EA., et al.[2023]

Transvaginal ultrasonography (TVUS) demonstrated higher sensitivity (80%) compared to computed tomography (CT) (46.7%) in detecting ascites in women with advanced gastric carcinoma, making it a valuable diagnostic tool.

TVUS also showed 100% specificity and positive predictive value, indicating it is effective in accurately predicting the presence of peritonitis carcinomatosa, which can help avoid unnecessary invasive surgeries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Usefulness of preoperative transvaginal ultrasonography for women with advanced gastric carcinoma. Nozoe, T., Matsumata, T., Sugimachi, K.[2016]

Transvaginal ultrasound (TVUS) guided biopsy procedures demonstrated a high diagnostic yield of 98.9% and a concordance rate of 94.7% in diagnosing pelvic lesions, making it an effective method for obtaining tissue samples.

The TVUS approach significantly reduced the distance to the target lesion (1.1 cm compared to 8.6 cm for transabdominal methods), while maintaining a favorable safety profile with only 8.3% minor complications and no post-biopsy infections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ultrasound-guided transvaginal biopsies of pelvic lesions: diagnostic yield, safety profile, and technical considerations over a 20-year experience. Wood, EJ., Pickhardt, PJ., Elissa, M., et al.[2023]

Transvaginal ultrasound (TVUS) has been found to have acceptable diagnostic performance for detecting cervical invasion in endometrial carcinoma, with a sensitivity of 63% and specificity of 91% based on a review of 17 studies involving 1751 women.

Despite its effectiveness, there is a high risk of bias in some studies regarding patient selection and the testing methods used, which may affect the reliability of the results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diagnostic Performance of Transvaginal Ultrasound for Detecting Cervical Invasion In Women With Endometrial Carcinoma: A Systematic Review and Meta-analysis. Alcázar, JL., Pérez, L., Güell, O., et al.[2019]

Transvaginal ultrasound (TVU) can detect cervical shortening in high-risk pregnant women earlier than traditional digital examinations, potentially identifying those at risk for preterm delivery.

In a study of 17 women, all three participants who required hospitalization for complications had cervical lengths measured by TVU that were less than 20 mm, indicating that TVU may be a crucial tool for early intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vaginal ultrasound as an adjunct to cervical digital examination in women at risk of early delivery. Zlatnik, FJ., Yankowitz, J., Whitham, J., et al.[2017]

In a study of 129 postmenopausal women, those with an endometrial thickness of 15 mm or greater had a cancer rate 3.043 times higher, highlighting the importance of monitoring endometrial thickness in detecting potential malignancies.

Symptomatic patients, especially those experiencing bleeding, showed a significantly higher cancer rate compared to asymptomatic patients, indicating that transvaginal ultrasound (TVUSG) is a valuable screening tool for endometrial pathologies in postmenopausal women.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of the histopathological results of the endometrial thickness detected by transvaginal ultrasound of symptomatic and asymptomatic postmenopausal women. Ulu, I., Celik, A., Haliloğlu, B., et al.[2020]

In a study of 58 postmenopausal women with type II endometrial cancer, transvaginal ultrasound (TVUS) showed that about 27.5% had a thin or indistinct endometrial stripe, indicating that TVUS may not be as effective for detecting abnormalities in this type of cancer.

Despite some patients having a thin endometrial stripe, around 10% showed no ultrasound abnormalities, suggesting that endometrial sampling should be performed for all women with postmenopausal bleeding, regardless of ultrasound findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Use of Transvaginal Ultrasound in Type II Endometrial Cancer. Billingsley, CC., Kenne, KA., Cansino, CD., et al.[2018]

Transvaginal ultrasonography (TVUS) is highly effective for diagnosing gynecologic issues due to its high accuracy, noninvasiveness, and ability to provide detailed images of the female reproductive tract using high-frequency probes.

TVUS can also identify various non-gynecologic conditions affecting nearby organs, such as the intestines and urinary system, making it a versatile tool for pelvic assessments and guiding interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transvaginal ultrasonography of nongynecologic pelvic lesions. Serafini, G., Gandolfo, N., Gandolfo, N., et al.[2019]

In a study of 107 breast cancer patients on tamoxifen, transvaginal ultrasonography (TVU) showed an increase in endometrial thickness over one year, but it was not effective as a standalone screening tool for endometrial pathology due to discrepancies with biopsy results.

TVU had moderate sensitivity (63.3%) and low specificity (28.57%), indicating that relying solely on TVU could lead to unnecessary invasive procedures, as it does not accurately predict endometrial conditions like atypical hyperplasia or polyps.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The value of transvaginal ultrasonography in the endometrial evaluation of breast cancer patients using tamoxifen. Kazerooni, T., Ghaffarpasand, F., Mosalaei, A., et al.[2016]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11477206/

Transvaginal Natural Orifice Transluminal Endoscopic ... Background: Minimally invasive surgery could improve cosmetic outcomes and reduce the risks of surgical injury with less postoperative pain ...

2. bmcwomenshealth.biomedcentral.com bmcwomenshealth.biomedcentral.com/articles/10.1186/s12905-024-03226-5

Clinical efficacy and safety of transvaginal natural orifice ... vNOTES can be considered a more minimally invasive surgical approach, as it results in reduced postoperative pain, faster recovery, and absence of visible ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0301211524000538

Transvaginal natural orifice transluminal endoscopic ... vNOTES can make patients mitigate postoperative discomfort, accelerate the recovery of gastrointestinal function, curtail hospitalization duration,

4. obgyn.onlinelibrary.wiley.com obgyn.onlinelibrary.wiley.com/doi/10.1002/ijgo.70342

Vaginal natural orifice transluminal endoscopic surgery for ... To describe outcomes of using a vaginal assisted natural orifice transluminal endoscopic surgery (vNOTES) approach to perform hysterectomy ...

5. e-ce.org e-ce.org/journal/view.php?number=8027

Natural orifice transluminal endoscopic surgery Hybrid NOTES, particularly transvaginal techniques, has demonstrated significant benefits, including reduced postoperative pain, faster recovery ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11225116/

Clinical efficacy and safety of transvaginal natural orifice ... The findings revealed that the vNOTES group exhibited superior postoperative health outcomes at both the 1-month and 6-month intervals compared ...

7. eurjmedres.biomedcentral.com eurjmedres.biomedcentral.com/articles/10.1186/s40001-024-02202-x

Feasibility and safety of transvaginal natural orifice ... To investigate the feasibility and safety of Transvaginal Natural Orifice Transluminal Endoscopic Surgery (V-NOTES) panhysterectomy.

8. obgyn.onlinelibrary.wiley.com obgyn.onlinelibrary.wiley.com/doi/10.1111/aogs.14889

Early surgical outcomes of 550 consecutive patients treated ... The application of transvaginal natural orifice transluminal endoscopic surgery appears safe and feasible for most benign gynecological surgeries.

9. sciencedirect.com sciencedirect.com/science/article/pii/S2405844024070452

Surgical outcomes of transvaginal natural orifice ... This study aimed to assess the surgical outcomes and identify the conversion risk factors of Transvaginal Natural Orifice Transluminal ...

10. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12020209/

Transvaginal natural orifice transluminal endoscopic surgery ... The vNOTESTEP study is a randomized controlled trial (RCT) enrolling 72 patients requiring laparoendoscopic surgery for tubal ectopic pregnancy.