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Prolapse clinical trials

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NCT ID: NCT04637022 Recruiting - Uterine Fibroid Clinical Trials

4K Versus 3D Laparoscopic Colporraphy by Surgeons in Training: a Prospective Randomized Trial

Start date: January 25, 2021
Phase:
Study type: Observational

This prospective randomized trial aims to assess if the operative time of vaginal cuff suture performed by trainees could be reduced using 3D laparoscopy instead of 4K laparoscopy.

NCT ID: NCT04623593 Recruiting - Clinical trials for Cervical Spondylosis

Cervical Arthroplasty Cost Effectiveness Study (CACES)

CACES
Start date: January 17, 2022
Phase: N/A
Study type: Interventional

To date, no consensus exists on which anterior surgical technique is more cost-effective to treat cervical degenerative disc disease (CDDD). The most commonly used surgical treatment for patients with single- or multilevel symptomatic CDDD is anterior cervical discectomy with fusion (ACDF). However, new complaints of radiculopathy and/or myelopathy commonly develop at adjacent levels, also known as clinical adjacent segment pathology (CASP). It remains unknown to what extent kinematics, surgery-induced fusion and natural history of disease play a role in its development. Anterior cervical discectomy with arthroplasty (ACDA) is thought to reduce the incidence of CASP by preserving motion in the operated segment. ACDA is often discouraged as the implant costs are higher whilst the clinical outcomes are similar to ACDF. However, preventing CASP might be a reason for ACDA to be a more cost-effective technique in the long-term. In this randomized controlled trial patients will be randomized to receive ACDF or ACDA in a 1:1 ratio. Adult patients with single- or multi-level CDDD and symptoms of radiculopathy and/or myelopathy will be included. The primary outcome is cost-effectiveness and cost-utility of both techniques from a societal perspective. Secondary objectives are the differences in clinical and radiological outcomes between the two techniques, as well as the qualitative process surrounding anterior decompression surgery. All outcomes will be measured at baseline and every 6 months till 4 years postoperatively. High quality evidence regarding the cost-effectiveness of both ACDA and ACDF is lacking, to date no prospective trials from a societal perspective exist. Considering the ageing of the population and the rising healthcare costs, the need for a solid clinical cost-effectiveness trial addressing this question is high.

NCT ID: NCT04564677 Recruiting - Rectal Prolapse Clinical Trials

A Study Evaluating the Clinical Outcome of a Modified d'Hoore Technique for Laparoscopic Ventral Mesh Rectopexy

POP-01
Start date: February 8, 2021
Phase:
Study type: Observational

The purpose of this observational study is to evaluate the clinical outcome of a modified d'Hoore technique for laparoscopic ventral mesh rectopexy in patients with primary rectal prolapse, rectocele and/or enterocele.The goal of the study will be achieved by reporting the peri- and postoperative complications ((serious) adverse events), recurrences and re-interventions. Pre-operative to postoperative changes in pain, functional outcome and quality of life will be evaluated as well.

NCT ID: NCT04560543 Recruiting - Prolapse Pelvic Clinical Trials

Prophylactic Laparoscopic Suspension After McCall

LAPCALL
Start date: May 15, 2021
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT04547816 Recruiting - Clinical trials for Functional Constipation

Efficacy of Conservative Treatment of Functional Defecatory Disorders in Females With Pelvic Organ Prolapse

Start date: July 1, 2020
Phase: Phase 3
Study type: Interventional

This study is planned to evaluate the efficacy of complex conservative treatment (including tibial neuromodulation, biofeedback therapy, special pelvic floor training and diet modification) in women with pelvic organ prolapse

NCT ID: NCT04537169 Recruiting - Congenital Ptosis Clinical Trials

Clinical Significance of Whitnall Ligament Structure

Start date: August 20, 2020
Phase:
Study type: Observational

Prospective clincal study to relate the structure of Whitnall ligament in cases of congenital ptosis to the severety of ptosis and the postoperative results.

NCT ID: NCT04478747 Recruiting - Clinical trials for Prolapse, Vaginal Vault

Transvaginal Mesh vs. Laparoscopic Colposacropexy- Study

TVM vs LCSP
Start date: July 1, 2020
Phase: N/A
Study type: Interventional

The main objective of the study is to compare subjective efficacy of trans vaginal mesh and laparoscopic colposakropexy (CSP) in women with an apical prolapse. The CSP group is further divided into two sub-groups; one where the mesh fixation is only at the apical part of the vagina, and another where the fixation is also extended to the levator plane. The secondary outcomes are safety (peri- and post-surgery complications, pain, erosion), objective efficacy (simplified POP-Q), and re-operation rate. Subjective outcome also includes the assessment of sexual satisfaction. Cost-effectiveness is studied by comparing both direct costs and QALYs.

NCT ID: NCT04440475 Recruiting - Pain, Postoperative Clinical Trials

Tap Block vs Conventional Pain Medication for Patients Undergoing Robotic Sacrocolpopexy

SACROTAP
Start date: June 28, 2020
Phase: N/A
Study type: Interventional

The purpose of this study is to assess whether the transversus abdominis plane block (Tap block) is different than the oral postoperative pain medications in controlling pain after robotic sacrocolpopexy.

NCT ID: NCT04429360 Recruiting - Overactive Bladder Clinical Trials

What is the Effect of Prolapse Surgery on Voiding?

PROVOID
Start date: June 8, 2020
Phase:
Study type: Observational

The aim of our study is to examine the effect of prolapse surgery on voiding. Our study is the very first one to combine several innovative low-invasive and low-cost methods to analyse the amelioration or deterioration of voiding function after surgery for pelvic organ prolapse using 3D/4D translabial ultrasound, home-uroflowmetry and patient reported quality of life outcomes.

NCT ID: NCT04428320 Recruiting - Surgery Clinical Trials

The Effect of Preemptive Levator Ani Injections on Pain After Pelvic Reconstructive Surgery

Start date: May 21, 2020
Phase: N/A
Study type: Interventional

Patients undergoing vaginal pelvic reconstructive surgery for pelvic organ prolapse (POP) under general anesthesia will be randomized to receive bilateral trans-vaginal pelvic floor muscle injections with bupivacaine or no injection (standard of care) as a part of their surgical pain control