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Prolapse clinical trials

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NCT ID: NCT03216083 Recruiting - Clinical trials for Pelvic Organ Prolapse

Does Intravenous Tranexamic Acid Reduce Blood Loss During Vaginectomy?

Start date: January 1, 2018
Phase: Phase 3
Study type: Interventional

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.

NCT ID: NCT03146195 Recruiting - Clinical trials for Pelvic Organ Prolapse

The 3D Reconstruction Research of Pelvic Organ Prolapse Disease

Start date: September 2016
Phase: N/A
Study type: Observational

Female pelvic organ prolapse (FPOP) is one of the main diseases affecting the quality of life of middle aged and elderly women in non-neoplastic diseases. An aging population makes the incidence of this disease to increase year by year. Surgical operation is the main treatment. While the recurrence rate of classic repair surgery is high, the method of patch implantation reinforces the supporting force, which significantly reduce the recurrence rate. However, this method is costly and is associated with complications which may trigger new symptoms. As such, there is still no perfect surgical method. The main reason for this is that the assessment method of pelvic defects is crude and indirect, which results in the diagnosis of FPOP only representing external problems whereas, inner defected parts are not properly assessed. In recent years, research with the use of 2D and 3D MRI reconstructions on the anus levator muscle and ligament has become a hot topic. It found that the characteristic of the high resolution of soft tissue in the magnetic resonance imaging (MRI) has a big advantage in pelvic floor study.The investigators commenced the study of 3D reconstruction technology based on the MRI datasets in 2009. The investigators have mastered the most common, key technologies of MRI three-dimensional reconstruction. The investigators have done research targeted on the reconstruction methods of the normal pelvis, viscera, ligaments, pelvic floor muscles. This project is aimed at 3D reconstruction of the whole pelvic base on static and dynamic MRI images from FPOP patients, and establish the corresponding space coordinates assessment system to do location and quantitative research of the pelvic viscera and its support structure, thus providing a FPOP diagnosis platform that is more precise, direct and comprehensive.

NCT ID: NCT03113552 Recruiting - Clinical trials for Mitral Valve Prolapse

Prognostic Impact of the Location of Mitral Valve Prolapse on the Long-term Results of Mitral Plasty

IPPVM
Start date: February 4, 2013
Phase:
Study type: Observational

Mitral insufficiency (MI) accounts for 24% of adult valvulopathies and affects 7% of subjects older than 75 years. They are the second leading cause of valvulopathy in Europe. The most common etiology is the associated valvular prolapse. Mitral surgery remains the reference treatment for symptomatic MI. The success of this procedure depends on the mitral valve geometry and the location of the prolapse. The site of the prolapse, whether monovalvular, localized to the posterior or anterior leaflet, or bivalvular, influences the possibilities and probably the long-term results of the plasty.

NCT ID: NCT03095716 Recruiting - Uterine Prolapse Clinical Trials

Laparoscopic Surgery in Elderly Patients

Start date: October 2016
Phase: N/A
Study type: Observational

The primary purpose is to evaluate the quality of post-operative recovery and post-operative pain in elderly patients (more than 75 years) who undergo laparoscopic surgery for uterine prolapse.

NCT ID: NCT03060330 Recruiting - Clinical trials for Chronic Constipation

Laparoscopic Ventral Mesh Rectopexy Combined With or Without Stapled Trans-anal Rectal Resection for Obstructed Defecation Syndrome

Start date: April 26, 2017
Phase: N/A
Study type: Interventional

Obstructed defecation syndrome (ODS) is a common problem in women. Rectal prolapse and rectocoele are frequently identified in patients with ODS. Surgery is the only definite treatment for those patients and is preferably performed minimally invasive. The most used procedures are laparoscopic ventral mesh rectopexy (LVMR) and stapled trans-anal rectal resection (STARR). However, high-level prospective studies on treatment strategies for ODS currently are lacking and, thus, no consensus exist regarding the optimal treatment for patients with ODS. This study aimed to compare LVMR alone and LVMR combined with STARR evaluating functional and anatomical results.

NCT ID: NCT03049020 Recruiting - Clinical trials for Pelvic Organ Prolapse Recurrence

The Efficacy of Laparoscopic Sacrocolpopexy in the Treatment of Pelvic Organ Prolapse in Women With or Without Avulsion of the Levator Ani Muscle

Start date: October 2014
Phase: N/A
Study type: Observational

Based on a prospective study, to evaluate how pre-operative pelvic floor status - the presence of injury to the musculus levator ani - may influence the results of laparoscopic sacrocolpopexy. The investigators hope to confirm or disprove the hypothesis that the presence of such injury increases the risk of post-operative prolapse recurrence

NCT ID: NCT03048682 Recruiting - Surgery Clinical Trials

Timing of Repeat Voiding Trials After Outpatient Pelvic Floor Surgery

Start date: January 5, 2017
Phase: N/A
Study type: Interventional

This study is a randomized controlled trial designed to assess the rate of failure of voiding trials in the early and late post-operative period within patients who underwent outpatient pelvic floor surgery that failed initial same day voiding trials.

NCT ID: NCT03012464 Recruiting - Rectal Prolapse Clinical Trials

Pathologic Assessment of Rectal Prolapse in the Young

Start date: January 2017
Phase: N/A
Study type: Observational

Patients aging less than 45 years with rectal prolapse will undergo full pathologic and functional assessment to determine the underlying etiology.

NCT ID: NCT03005613 Recruiting - Urogenital Prolapse Clinical Trials

Sacrospinous Ligament Fixation vs Ischial Spine Fascia Fixation

Start date: January 2017
Phase: N/A
Study type: Interventional

A Prospective, Randomized Comparison of Efficacy and Effect on Quality of Life Between Sacrospinous Ligament Fixation and Ischial Spine Fascia Fixation.

NCT ID: NCT02999724 Recruiting - Clinical trials for Pelvic Organ Prolapse

Gabapentin Reduces Opioid Use Postoperatively ("GROUP Study")

GROUP
Start date: January 2017
Phase: Phase 3
Study type: Interventional

Gabapentin is a medication used primarily to treat seizures and pain. Studies have shown that this medication can help reduce pain after surgery, including hysterectomy, where the uterus or "womb" is removed. Opioids are the first choice for pain medication administered after surgery, but carry significant side effects. Several studies have demonstrated that if patients are given gabapentin before surgery, they require less opioids after surgery. However, there have not been any studies examining gabapentin's effects on post-operative pain in urogynecologic surgery, which treats pelvic organ prolapse and urinary incontinence. Pelvic organ prolapse occurs when female pelvic floor supports have weakened and therefore patients experience a "bulge" or "pressure" in the vagina. Patients with these conditions are typically offered medical treatments, but some may require surgery, and this usually consists of vaginal hysterectomy, pelvic floor repair, and a mid-urethral sling to treat any concurrent urinary incontinence. Our study aims to look at the effect of gabapentin given to patients undergoing urogynecologic surgery on their pain levels after surgery, including the amount of opioid pain medication required. We hypothesize that the patients who receive gabapentin before surgery will require significantly less opioids. Over a six-month period, patients seen in Urogynecology clinics will be invited to participate in the study. Women who are already on gabapentin for other reasons, have an allergy to gabapentin, have a reason they cannot take gabapentin, or who cannot understand spoken English will be excluded from the study. After providing informed consent, they will be randomized to either receive gabapentin or a placebo pill. They will receive the standard surgical care, including the usual anesthesia for surgery and routine pain medications available after surgery. We will then compare the differences in opioid consumption in the first 24 hours after surgery as well as the time from the end of surgery to leaving to the recovery room and the length of recovery room stay between the gabapentin and placebo groups. We will also analyze the differences in anxiety, drowsiness, pain, and nausea as rated by the patients in each group.