Active clinical trials for "Prolapse"

The aim of the study will be to compare the laparoscopic pectopexy (LP) and laparoscopic lateral suspension (LLS) techniques in the management of uterine sparing apical prolapse (POP-Q >2) at 1 year and yearly up to 2 years.

Pelvic organ prolapse (POP) is a major public health concern that adversely affects the physical and psychological well-being of women. In fact, the lifetime risk of POP surgery is 12.6%, highlighting the magnitude of the problem. The most common form of POP involves defects in the anterior vaginal wall accompanied by apical prolapse. The primary objective of surgical treatment for POP is to mitigate symptoms and restore the pelvic support anatomy. Normally, the vaginal axis is directed posteriorly towards the S3 and S4 vertebrae, lying relatively horizontally to the levator plate, and forming an angle of about 130º between the middle and lower vagina. Although sacrocolpopexy (SCP) is considered the gold standard for treating POP, it alters the normal anatomical position of the vaginal axis towards the sacral promontory, which may increase the abdominal pressure load on the anterior wall and cause urge symptoms or de novo anterior compartment prolapse. Similarly, sacrospinous ligament fixation (SSLF) increases the risk of anterior vaginal wall prolapse, as it deviates the vaginal axis towards the posterior. However, laparoscopic lateral mesh suspension has recently become popular because it preserves the normal position of the vaginal axis, preventing such complications. A previous study found that the pectineal ligament (Cooper's ligament) is composed of stronger and more durable tissue than the sacrospinous ligament and arcus tendineus of the fascia pelvis. This structure is robust and can hold sutures well, and it is possible to find sufficient material for a suture in the lateral part of the iliopectineal ligament, facilitating pelvic floor reconstruction. This segment of the ligament is located at the second sacral vertebra (S2) level, which is the optimal level for the physiological axis of the vagina. S2 level serves as the anchor point for the physiological axis of the vagina. Further studies have demonstrated that laparoscopic pectopexy provides outcomes comparable to those of laparoscopic sacrocolpopexy for supporting the apical compartment during intermediate follow-up duration. The current study aimed to investigate the level of anatomical correction following laparoscopic pectopexy and compare the vaginal axis of patients with apical genital prolapse to that of nulliparous women using magnetic resonance imaging (MRI).

The goal of this clinical trial is to compare Dermabond with non-absorbable sutures in skin closure after brow ptosis surgery. The main questions it aims to answer are: if Dermabond provides equivalent wound healing compared to conventional non-absorbable skin suture techniques if Dermabond provides equivalent scar appearance compared to conventional non-absorbable suture techniques if Dermabond results in equivalent complication rates compared to conventional non-absorbable suture techniques Participants will have be randomly selected to have either Dermabond or non-absorbable suture closure methods. Scar analysis and both participant and provider surveys will be performed to assess the differences between groups, if any.

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.

Chronic lumbar radicular (CLR) pain is a term used to describe neuropathic pain symptoms in the distribution of a particular lumbar nerve root due to disc protrusion, spinal stenosis, facet hypertrophy, or fibrosis after previous surgery. The pathophysiology of CLR pain involves mechanical, inflammatory, and immunologic factors that affect the function of the dorsal root ganglion (DRG).1Treatment methods include oral pain medications, physical therapy, epidural steroid injection (ESI) and surgery. 2,3. Pulsed radiofrequency (PRF) was developed as a modification of the well-known radiofrequency ablation treatment. In conventional radiofrequency ablation, a high frequency alternating current is used to produce coagulative necrosis of the target nerve tissue without any selectivity for nociceptive fibers. However, in PRF, a current in short (20 msec) high voltage bursts is followed by silent phases (480 msec) which allow for heat dissemination, keeping the target tissue controlled below 42°C. 4,5 The mechanisms via which PRF causes analgesia are still not clearly understood, but laboratory experiments have highlighted some possible ways in which it might act, including its effects on neuropathic pain. Clinical use of PRF has been expanding, despite there being limited evidence of clinical efficacy in the form of randomized controlled trials (RCTs). 6 There have been few RCTs using PRF-DRG for radicular pain. Van Zundert et al performed an RCT in subjects with cervical radicular pain.7 Simopoulos et al did a pilot study on lumbar radicular pain, but the methodology included application of conventional radiofrequency over PRF in the study group and was not an efficacy trial. As such, the efficacy of PRF-DRG in CLR has never been determined. 8 Neuroplasticity or neuronal plasticity refers to the ability of the nervous system to do neuronal remodeling, formation of novel synapses and birth of new neurons. Neuronal plasticity is intimately linked to cellular responsiveness and may therefore be considered an index of the neuronal capability to restore its function. Failure of such mechanisms might enhance the susceptibility to neuronal injury.9 Neurotrophic factors (NTFs), and in particular the neurotrophin family, play an important role. In fact, besides their classical role in supporting neuronal survival, NTFs finely modulate all the crucial steps of network construction, from neuronal migration to experience-dependent refinement of local connections. It is now well established that NTFs are important mediators of neuronal plasticity also in adulthood where they modulate axonal and dendritic growth and remodeling, membrane receptor trafficking, neurotransmitter release, synapse formation and function.10 The neurotrophin brain-derived neurotrophic factor (BDNF) has emerged as crucial mediator of neuronal plasticity, suggesting that it might indeed bridge experience with enduring change in neuronal function.11BDNF acts on certain neurons of the central nervous system and the peripheral nervous system, helping to support survival of existing neurons, and encouraging growth and differentiation of new neurons and synapses.12,13 S100B belongs to the family ofcalcium binding proteins, is expressed mainly by astrocytesand is found both intra- and extracellularly in brain tissue. It was also reported that mature myelinating and non-myelinating Schwann cells of peripheral nerves strongly display S100 protein immunoreactivity (Stefansson et al., 1982; Sugimura et al., 1989; Vega et al., 1996).14 S100B can spill from injured cells and enter the extracellular space or bloodstream. Serum levels of S100B increase in patients with neuronal damage. Over the last decade, S100B has emerged as a candidate peripheral biomarker of neuronal injury. Elevated S100B levels accurately reflect the presence ofneurodegenerayion. Its potential clinical use in the therapeutic decisions is substantiated by a vast body of literature. Thus, the major advantage of using S100B is that its elevatio in serum provides a sensitive measure for determining neuronal injury at the molecular level before gross changes level.15

To determine whether a pre-operative educational video has an impact on the anxiety of patients undergoing vaginal prolapse surgery

The primary objective of this study is to estimate the effect of lidocaine jelly on patient pain at the time of office pessary removal.

There is prove of prolapse prevention in vaginal hysterectomy using the McCall suture. Poor and especially no long-term data exists for a standardized laparoscopic approach, but the few studies could show good anatomic results. The aim is to test the effectiveness of the laparoscopic McCall suture compared to usual vaginal cuff closure in a randomized controlled double-blinded trial.

There is not a study in the literature comparing laparoscopic pectopexy and laparoscopic lateral suspension (LLS) surgeries in the surgical treatment of pelvic organ prolapse. However, there are studies comparing the efficacy of other surgery types for pelvic organ prolapse. For example,In a study, the clinical and anatomical success rate in LLS operations was 83.8%, while the success rate in abdominal sacropexy operation was 89.2%.In another study in which pectopexy and vaginal sacro spinous fixation operations were compared, apical prolapse recurrence rates were found to be similar in both groups.

The CREDE pilot randomized study will compare the intraoperative Crede manoeuver (M1) to preoperative prolapse (POP) reduction cough stress test (M2) for the prediction and prevention of PONSUI. The rates of PONSUI and its effect on patient reported outcomes and quality of life will be determined among women with positive or negative tests, and those with and without concomitant anti-incontinence procedure performed. This information will help inform larger studies on the topic.