View clinical trials related to Prolapse.
Filter by:The primary objective of this study is to evaluate the safety and performance of the Harpoon Medical Device. It is anticipated, that the Harpoon Medical Device will provide advantages over current surgical interventions including: 1) a small minimally invasive incision, 2) no sternotomy, 3) no cardiopulmonary bypass, 4) no aortic manipulation, 5) a direct path to the valve plane, 6) performed on a beating heart, 7) real-time TEE-guided ePTFE cordal length adjustment and 8) less complicated procedure that is teachable and adoptable.
Pelvic organ prolapse(POP) is a common health problem and has significant negative effects on woman's quality of life. Transvaginal mesh procedure is a durable reconstructive surgery, but the mesh kits are expensive for underdeveloped countries. Our preliminary trial showed that the use of self-tailored mesh had good success rate (91.8% at 1-year follow-up) and low complication rate. The trial is designed to compare self-tailored titanium-coated polypropylene mesh procedure with mesh-kit in the treatment of POP stage III-IV in terms of efficacy, safety and cost-effective .
The aim of the study was to assess the role of the Exair transvaginal mesh system to correct pelvic organ prolapse from a subjective and objective standpoint. Subjects treated with the Exair transvaginal mesh for prolapse between June 2013 and August 2015 was analyzed. Subjects with uterine prolapse underwent vaginal mesh hysteropexy. There were no hysterectomies done for uterine prolapse in this study. A composite score that included subjective criteria of absence of a bothersome bulge, no prolapse below the hymen and no retreatment was used to assess success.Transvaginal Exair mesh hysteropexy offers a good option for the management of large uterine prolapses precluding the need for a hysterectomy.
In current practice, packing in the vagina overnight after vaginal surgery is typically used to prevent post-surgical vaginal bleeding. The vaginal packing is usually coated with either estrogen cream or bupivacaine at the investigators' hospital . There are reports in the literature that show nasal packing soaked with local anesthetic after nasal sinus surgery reduces post-surgical pain. To date, no studies have evaluated local anesthetic soaked vaginal packing after vaginal surgery and if this is associated with a reduction in post-surgical pain scores. The investigators seek to investigate if vaginal packing soaked with a local anesthetic reduces post-operative pain while providing the necessary action of minimizing potential post-surgical bleeding.
OBJECTIVE: To find out the effectiveness of physical therapy for stages I and II pelvic organ prolapse. DESIGN: Randomized, controlled and single blinded clinical trial. Patients will be randomly assigned to one of these groups: Experimental group: physical therapy + training in lifestyle advice; Control group: just training in means of lifestyle advice. In both groups several physical therapy assessments will be undertaken: 1st before intervention; 2nd immediately after completing intervention; 3rd, 4th, 5th and 6th after 3, 6, 12 and 24 months. SUBJECTS: Women with previously untreated prolapse of stage I or II (confirmed by their gynaecologist using the POP-Q) in Príncipe de Asturias Hospital, provided that there is no contraindication for physical therapy, and after reading, understanding and freely signing an informed consent form. SAMPLE SIZE: A total of 120 subjects will be included in the study (60 subjects in each group). DATA ANALYSIS: A descriptive analysis will be done of all the variables, as well as bivariate analysis in order to find all the possible relationships between the variables. A confidence level of 95% (p<0.05) will be established for all the cases. Effectiveness will be evaluated by comparing between the two groups of the change in outcome variables between visits.
to evaluate the surgical effect of levator aponeurosis resection Versus two point fixation levator aponeurosis Tucking for Congenital Ptosis
Surgery for Stage II-III Pelvic organ prolapse
This is a double (physician and patient) blinded randomized controlled clinical trial in which patients who have undergone bilateral direct brow ptosis repair undergo a trial in which one of brow is injected with placebo 0.9% Normal Saline and the contra-lateral brow is injected with 0.3-0.6 mL over the entire brow of 50mg/mL 5-Fluorouracil sub-dermal injections. The researchers aim to investigate whether injecting 5-Fluorouracil preemptively will not only accelerate wound healing and decrease hypertrophic scar formation compared to placebo, but also improve overall scar appearance in a safe manner.
There are many risks for patients undergoing surgery, with blood loss and the risk of resulting anemia and blood transfusion being a common one. Decreasing blood loss with medication can be an important tool in reducing post-operative complications. Tranexamic acid (TXA) is an anti-fibrinolytic that inhibits the activation of plasminogen to plasmin. It inhibits the ability of plasminogen to dissolve fibrin networks, thus decreasing bleeding. TXA was shown in a systematic review and meta-analysis by Ker et. al in 2013 to reduce surgical blood loss by an average of 34% with an increased percentage reduction as the amount of bleeding during surgery decreased. This review also showed that a dose of 1g intravenous (IV) was sufficient in most adults with no evidence supporting a higher dose. Vaginectomy or total colpocleisis is a surgical procedure performed for women experiencing symptomatic pelvic organ prolapse. It is performed in women who have significant vaginal vault prolapse post-hysterectomy and wish an effective treatment but accept the inability of having penetrative vaginal intercourse. It is most often performed in older patients who have multiple co-morbidities that would preclude them from having a more invasive procedure to correct their prolapse, such as an abdominal sacral colpopexy which involves the placement of surgical mesh, is a significantly longer procedure, and has more associated surgical risks. This study will be a double-blind, placebo-controlled, randomized trial looking at whether 1g IV tranexamic acid compared with placebo reduces blood loss in women undergoing vaginectomy.
The investigators anticipate a reduced risk of post-operational de novo stress urinary incontinence following surgery for vaginal sacrospinofixation, associated with reduced costs, comparable functional and anatomical efficacy and no increase in morbidity and rate of dyspareunia with the new treatment