21 Clinical Trials for Various Conditions
The purpose of this study is to determine whether green draping in the operating room prior to a hysteroscopy results in a decreased operating room time. Secondary aims are to determine whether there are any differences in infection rate, complication rate, fluid deficit, operating room turnover time
Office hysteroscopy is an invaluable practice to treat a myriad of gynecological processes. However, a limiting factor is the perceived pain and anxiety. In a randomized pilot study, treatment with lavender aromatherapy will significantly decrease the stress/anxiety levels associated with office hysteroscopy, as measured on a visual analogue scale and the Hospital Anxiety and Depression Scale (HADS) questionnaire when compared to control subjects receiving distilled water placebo.
Safety during operative hysteroscopy requires a fluid management system to assist in gauging patient fluid absorption of media used for visualizing the uterine cavity. Serious patient complications, including hyponatremia (low serum sodium), heart failure, and pulmonary and cerebral edema, can result from over absorption of this distending medium. Failure of surgical drapes to collect unabsorbed fluid causes inaccurate determination of the hysteroscopic fluid deficit (HD) thus preventing proper risk evaluation for patient fluid overload, could prompt premature procedure terminatio, and result in hazards for the OR team. Specific Aims: 1. To perform a comparative trial of the "Total Capture" hysteroscopy drape (TCD) versus the standard drape during patient surgeries to document improved, real-time determination of patient fluid absorption. Pilot testing of a prototype design of the "Total Capture drape" versus the conventional hysteroscopy drape indicated remarkable improvement in fluid capture and accurate fluid deficit determination in a plastic pelvic model experiment. 2. To evaluate the clinical usefulness of the TCD compared to the Standard drape for hysteroscopy with the standardized metrics of: 1) the Technology Acceptance Model, and 2) The System Usability Scale. These metrics will allow us to quantitate clinical usefulness and usability of both the operating surgeons and operating room staff. The investigators hypothesize the "Total Capture" Drape design provides an accurate recorded hysteroscopic fluid deficit in real-time so that patient safety and surgical parameters are optimized. The simple design of the TCD would add a very significant improvement for patient safety and care with minimal cost for the estimated 200,000 hysteroscopies performed per year in the U.S.
A Phase II, multicenter, double-blind, randomized, placebo-controlled, dose-ranging, study to assess the efficacy and safety of the 100, 200, 400, 800, 1200 and 1600 mcg Misoprostol Vaginal Priming Insert (MVPI) for Women Requiring Cervical Priming prior to an in-office hysteroscopy procedure. Each subject will be randomized to receive one vaginal insert. The study drug will be administered vaginally by a member of the clinical research team (Part I) or insert herself (Part II) 18 - 24 hours prior to the scheduled hysteroscopy clinic visit. The internal os of the cervix will be measured at baseline, just prior to the hysteroscopy and at the follow up visit. The primary outcome measure is change in diameter of the internal cervical os from baseline (pre-treatment) to just prior to the hysteroscopy procedure (post-treatment). The hypothesis is that treatment with the MVPI will soften and dilate the cervix better than placebo.
The purpose of this study is to determine the effectiveness of paracervical block for pain relief in office hysteroscopy - particularly with the placement of the Essure device. Subjects will be randomized to receive either paracervical block or saline, and will have pain assessments performed throughout the procedure. Subjects and physicians will be blinded to group assignments.
A randomized double-blind placebo controlled trial comparing the effect of a combined ketorolac and lidocaine paracervical block with a standard lidocaine paracervical block on procedure related pain with office hysteroscopies.
Hysteroscopic surgery is widely used for the treatment of gynecological diseases, such as septum, synechiae, polyp and intrauterine fibroids. The complication rate is estimated as 0.22% and includes uterine perforation, massive bleeding, and fluid overload. Operative hysteroscopy intravascular absorption (OHIA) syndrome refers to fluid overload complications from operative hysteroscopies and is considered a major complication. Report describing the clinical association between irrigation fluid temperature to intravasation rate itself or the risk of fluid overload are limited mainly to theoretical models. Due to the aforementioned, we aim to evaluated the role of temperature on absorption of the irrigation solution in hysteroscopic surgery.
The purpose of this research is to look at the impact that phrases of likely discomfort or a description of the procedure have on the perception of pain during in-office hysteroscopy.
The Objective of this study is to compare pain levels in women undergoing office-based hysteroscopies using Virtual Reality versus control in a randomized control prospective trial.
The aim of the study is to compare the outcomes of patients undergoing hysteroscopy with a Myosure device with a pressure of 60 mmHg to those using the standard of 80 mmHg.
Saline infusion sonography (SIS) and hysteroscopy are commonly employed methods for uterine cavity evaluation. While hysteroscopy is regarded as the gold standard for diagnosis of intra-uterine pathology, it is not often used as an initial screening tool because of provider concerns about in-office tolerability, operating room costs, and use of anesthesia. The investigators aim to compare SIS and office hysteroscopy with respect to patient and provider satisfaction. Additionally, the investigators aim to assess the capability of office-based hysteroscopy to manage intra-uterine pathology at the time of diagnosis and reduce delays and supernumerary procedures.
We hypothesize that use of vaginal misoprostol will help in reducing the pain scores when used prior to concurrent office hysteroscopy and endometrial biopsy in a particular subgroup of women who are anticipated to require cervical dilatation.
Patients with chronic anovulation presenting to the IVF clinic for subfertility treatment are at increased risk of endometrial hyperplasia and carcinoma.They are often subjected to endometrial biopsy to rule out any underlying changes such as endometrial hyperplasia or carcinoma before commencing any further treatment. Literature shows that these group of patients have higher possibility of having underlying uterine abnormality (uterine polyp, fibroid, septum, or adhesion) and if we perform only endometrial biopsy, these structural abnormalities will remain undetected. And presence of uterine abnormalities lead to difficulty in implantation, which eventually leads to lower success rate of infertility treatment. WE propose that performing simultaneous office hysteroscopy followed by endometrial biopsy in such patients will lead to higher detection of uterine structural abnormalities and obtaining endometrial tissue to rule out hyperplasia or carcinoma. The concern for clinicians at times is that performing both the procedures together will lead to higher pain perception during the procedure. But with the introduction of flexible hysteroscope which has a diameter of 3.5 mm we hypothesize that the pain of performing office hysteroscopy with endometrial biopsy and performing endometrial biopsy alone will be equivalent. Meanwhile, hysteroscopy will lead lead to detection of underlying uterine pathology and help us in taking directed biopsies.
This study will look at the optimal order in which to perform concurrent office hysteroscopy and endometrial biopsy in female patients who present for evaluation of abnormal uterine bleeding at a fibroid and endometriosis treatment center.
This is a prospective, single center, multiple arm cohort study intended to compare the diagnostic accuracy of a Visual Saline Infusion Device (VSI) device, vs standard of care Hydrosonography in reproductive aged women to identify pathology in the uterus.
Hysteroscopy (an exam to look inside the uterus) is one of the most frequently performed procedures for patients with cervical or uterine disorders. It is the gold standard for evaluating various intrauterine problems, pre-menopausal and post-menopausal abnormal uterine bleeding, as well as being a vital examination modality for infertility work-up. Although hysteroscopy is a minimally invasive procedure, it is still known to be a painful experience that requires effective analgesia (meaning pain reduction) to achieve maximum patient comfort and cooperation. Historically, opioids, particularly fentanyl, have held precedence as the primary agents for providing analgesia following surgery of this type. However, despite their efficacy, these agents come with notable drawbacks, including the potential for serious side effects such as respiratory depression, addiction, and postoperative nausea and vomiting. Both magnesium and ketamine are routinely used to reduce pain following this procedure. Both drugs work on the N-methyl-D-aspartate (NMDA) receptor in the brain to reduce pain, and magnesium has an additional effect in that it can relax smooth muscles. Magnesium has been used successfully to reduce the pain associated with menstrual cramps, which is similar to the pain patients experience after hysteroscopy. A recent study demonstrated the benefits of adding intravenous magnesium with routine anesthesia during hysteroscopy, revealing a significant decrease in postoperative pain and rescue analgesics. However, this study did not compare the effects of magnesium to ketamine, nor did they characterize the nature of the patients' pain. It is unclear if the pain reduction with magnesium comes from its effect on the NMDA receptor or from it's cramp-reduction effect. We seek to establish whether administering IV magnesium, compared to ketamine, can specifically mitigate uterine cramping pain and total opioid consumption in hopes of finding additional safe and effective pain modalities for patients. This is a prospective, randomized trial enrolling participants undergoing an elective hysteroscopy or Dilation and Curettage (D\&C) at Corewell Health William Beaumont University Hospital in Royal Oak. Participants will be randomized to 1 of 3 treatments: Intravenous (IV) Magnesium, IV Push Ketamine, or Placebo. Opioid consumption is recorded via the electronic medical record (EMR), while overall pain and cramping pain will be captured post-procedure in the hospital and 24 hours later via a phone call.
The goal of this clinical trial is to compare pain perception in the study participant population undergoing the following gynecological procedures: Intra Uterine Device (IUD) insertion, hysteroscopy, and endometrial biopsy and given either Eutectic Mixture of Local Anesthetics (EMLA) cream or a placebo. The main question to answer is: • Does EMLA cream reduce pain when administered during the following gynecological procedures: IUD insertion, hysteroscopy, and endometrial biopsy? Participants will be asked to do assess their pain on the Visual Analogue Scale through 3 times during the procedure. Researchers will compare the study group with those receiving placebo group to see if there is a difference in pain scores.
Disease of the fallopian tubes is one of the most common reasons for infertility. The most common test, a hysterosalpingogram, tends to be painful,inconvenient, and frequently misses concurrent uterine disease. We propose using a less painful technique (through modified office hysteroscopy) for tubal assessment that can be performed in the office rather than hospital radiology and that uses gold standard technology for identifying coexisting uterine conditions.
When having certain types of outpatient surgery inside the uterine cavity some women experience heavy bleeding. The only method presently available for controlling such bleeding, short of removing the uterus, involves the placement of a balloon pressure device inside the uterine cavity. The pressure along with the patient's own natural clotting ability will generally stop the bleeding. However, this treatment usually requires at least a 24 hour stay in the hospital. The investigators are researching the use of a compound (FloSeal) already approved for use in other areas of the human body, as a method of controlling bleeding. The use of FloSeal in the uterine cavity has not yet been tested and therefore is not yet an FDA approved indication for its safe use to control bleeding from the uterine cavity. In this study, The investigators want to find out what effect(s) FloSeal has on the uterine cavity. Twenty individuals will be included in this study at Northwest Hospital Center. All twenty individuals will be treated in the same fashion except ten of the participants will randomly be assigned to receive FloSeal and ten will not. Study participants are individuals currently scheduled to have a hysterectomy procedure, which involves surgically removing the uterus from the body for a previously determined standard of care treatment for a non- cancerous medical problem. Before performing the hysterectomy and evaluating the effects of FloSeal upon the tissues within the uterine cavity the following will be done. Once under anesthesia the uterine cavity will be subjected to a curettage (sharp scrapping) to produce a minor amount of bleeding from the lining of the uterus. Ten of the 20 study participants, randomly chosen, will then have FloSeal placed into their uterine cavity. The study participants will not know whether they received FloSeal or not. A balloon pressure device will then be placed into the uterine cavity of all 20 individuals and left in place for 5 minutes. After the allotted time, the balloon device will be removed. The hysterectomy will then be completed appropriately using standard methods and techniques. The uterus, once removed will be evaluated pathologically to determine the effects of the FloSeal upon the tissues of the cavity in those so treated and compared to the same analysis in those individuals who did not receive FloSeal. The pathologist will not know which patients received or did not receive FloSeal. This use of FloSeal is not currently an FDA approved use of the compound. The goal of this study is to obtain FDA approval for use in this situation.
Very often patients receive medications before a diagnostic, therapeutic, or surgical procedure to help them relax, keep them calm, and to relieve them from pain. This is called procedural sedation. With respect to minimal-to-moderate procedural sedation for minor surgical procedures, a patient is first given a pain-relief medication (analgesic) and then a medication to help him/her relax and keep calm (sedative). AQUAVAN is a chemically modified form of propofol, a commonly-used sedative drug. AQUAVAN acts like a slow release version of propofol, and is being studied to see if it can safely keep patients calm and relaxed during their medical procedure and then allow for rapid and clear-headed recovery.
Tubal sterilization is the most prevalent form of contraception in the United States and the world. Currently, approximately half of these are performed with a laparoscope and half through a mini-laparotomy after delivery. Micro-insert hysteroscopic sterilization system received FDA approval for elective sterilization in 2003. Compared to other forms of female sterilization, this procedure is minimally invasive and does not require entering the abdominal cavity. In addition, it is at least as effective in preventing pregnancy as other forms of tubal occlusion. Given the distinct advantages of this method, it could become the preferred method of tubal sterilization for physicians and their patients. Currently, there is no published data concerning the appearance of the micro-inserts system using other imaging modalities that are commonly used in gynecologic practice. As the use of this device becomes more widespread it will be more commonly encountered in radiographic imaging performed as part of routine patient care. The main objective of this study is to provide important descriptive data concerning the ultrasonographic and x-ray appearance of the micro-insert hysteroscopic sterilization device. An additional objective of this study is to identify characteristics on plain film and ultrasound (US) that correlate with tubal occlusion or patency.