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

Trial Summary

What is the purpose of this trial?

This trial studies a minimally invasive surgery done through the vagina. It targets women needing non-cancerous pelvic surgeries but excludes those with severe PID or endometriosis. The technique uses a camera and tools through the vagina to avoid belly cuts, reducing pain and speeding up recovery. This scar-free technique offers shorter hospital stays and lower postoperative pain.

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 data supports the effectiveness of the treatment Trans-vaginal ultrasound, Transvaginal ultrasound, TVUS?

Research shows that transvaginal ultrasound (TVUS) is effective in diagnosing various conditions, such as cervical invasion in endometrial carcinoma and adnexal lesions, and is useful in guiding biopsies safely. This suggests that TVUS can be a reliable tool for evaluating and selecting surgical treatments. ^{1 2 3 4 5}

Is transvaginal ultrasound generally safe for humans?

Transvaginal ultrasound (TVUS) is generally considered safe for humans, as studies have evaluated its use in various conditions over many years without significant safety concerns. ^{3 4 6 7 8}

How does the ultrasound evaluation treatment differ from other treatments for surgery selection?

This treatment uses transvaginal ultrasound (TVUS), which is unique because it provides high diagnostic accuracy and is noninvasive, allowing for detailed imaging of pelvic structures. Unlike other methods, TVUS can guide surgical decisions by accurately assessing various pelvic conditions, making it a valuable tool for surgery selection. ^{1 2 3 5 9}

Research Team

Aya Mohr-Sasson

Principal Investigator

The University of Texas Health Science Center, Houston, TX

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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 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]

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]

References

1. Ireland pubmed.ncbi.nlm.nih.gov

O-RADS scoring system for adnexal lesions: Diagnostic performance on TVUS performed by an expert sonographer and MRI. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Usefulness of preoperative transvaginal ultrasonography for women with advanced gastric carcinoma. [2016]

3. United States pubmed.ncbi.nlm.nih.gov

Ultrasound-guided transvaginal biopsies of pelvic lesions: diagnostic yield, safety profile, and technical considerations over a 20-year experience. [2023]

4. England pubmed.ncbi.nlm.nih.gov

The Use of Transvaginal Ultrasound in Type II Endometrial Cancer. [2018]

5. England 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. [2019]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Vaginal ultrasound as an adjunct to cervical digital examination in women at risk of early delivery. [2017]

7. Singapore pubmed.ncbi.nlm.nih.gov

Comparison of the histopathological results of the endometrial thickness detected by transvaginal ultrasound of symptomatic and asymptomatic postmenopausal women. [2020]

8. Switzerland pubmed.ncbi.nlm.nih.gov

The value of transvaginal ultrasonography in the endometrial evaluation of breast cancer patients using tamoxifen. [2016]

9. United States pubmed.ncbi.nlm.nih.gov

Transvaginal ultrasonography of nongynecologic pelvic lesions. [2019]