What side effects are associated with this type of intervention?

Common side effects of minimally invasive surgeries, including those identified through pre-operation ultrasound for vNOTES, often include mild to severe pain, particularly related to tubal occlusion. Other frequent adverse events are vasovagal reactions, nausea, and minor complications such as hematoma or superficial wound infections. These side effects are generally manageable and rarely require significant medical intervention.

What prior FDA approvals exist?

The FDA has approved various treatments and techniques to optimize surgical outcomes and preoperative care. For instance, preoperative echocardiography is recommended for patients with aortic stenosis to guide perioperative management. Additionally, the use of tranexamic acid and cell salvage techniques are endorsed to minimize blood loss during surgery. While specific FDA approvals for pre-operation ultrasound to identify potential adhesions or contraindications for vNOTES are not detailed, the general approach of using imaging modalities to improve patient selection and surgical outcomes is well-supported in clinical practice.

What other types of research exist?

Promising novel alternatives to pre-operation ultrasound for identifying potential adhesions or contraindications for vNOTES include advanced MRI techniques, such as diffusion-weighted imaging (DWI) and magnetic resonance elastography (MRE), as well as the use of 3D and 4D imaging technologies. These methods offer enhanced visualization of soft tissues and can provide detailed information about the presence and extent of adhesions.

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Ultrasound Evaluation for Surgery Selection (PUP-VNOTES Trial)

N/A

Recruiting

Led By Aya Mohr-Sasson

Research Sponsored by The University of Texas Health Science Center, Houston

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from operation until one month post-operation

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial involves an ultrasound evaluation rather than medication, typical drug side effects aren't expected. However, there may be minor discomfort associated with undergoing an ultrasound.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from operation until one month post-operation

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from operation until one month post-operation

This trial's timeline: 3 weeks for screening, Varies for treatment, and from operation until one month post-operation for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Organ damage

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Candidates for vaginal natural orifice trans-luminal surgery approachExperimental Treatment1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Trans-vaginal ultrasound

2014

N/A

~1470

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Pre-operation ultrasound is a critical tool in surgical planning, particularly for procedures like Vaginal Natural Orifice Transluminal Endoscopic Surgery (vNOTES). It helps identify potential adhesions or contraindications, such as those caused by severe pelvic inflammatory disease or endometriosis. By providing detailed visualization of the pelvic area, ultrasound allows surgeons to select appropriate candidates and plan the procedure more effectively, thereby minimizing surgical risks and improving patient outcomes. This imaging technique ensures that only suitable patients undergo vNOTES, reducing the likelihood of complications and enhancing the overall success of the surgery.

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