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Prolapse clinical trials

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NCT ID: NCT06024109 Recruiting - Ovarian Cancer Clinical Trials

Performance of SYMMCORA® vs. V-Loc® Suture Material in Patients Undergoing Laparoscopic Total Hysterectomy

BARHYSTER
Start date: March 19, 2024
Phase:
Study type: Observational

The aim of this study is to show the superiority of the new unidirectional barbed suture (SYMMCORA® mid-term, unidirectional) to conventional suture material in terms of time to perform the vaginal cuff closure during gynecologic surgeries without an increase in the complication rate. Secondly, the superiority of SYMMCORA®, mid-term unidirectional compared to the V-Loc®, unidirectional will be assessed regarding the mean time to close the vaginal cuff. The study will be performed in routine clinical setting, the only difference will be the randomization into two different suture groups. Both suture materials which will be applied to approximate the vaginal cuff are approved and carrying the CE-marks. Additionally, both sutures will be applied in their intended use. Neither additional invasive measures nor additional burden in regard to the patient will be performed.

NCT ID: NCT06021769 Recruiting - Clinical trials for Pelvic Organ Prolapse

Pessary Experience Study

Start date: June 12, 2023
Phase:
Study type: Observational

Pessaries are silicone devices inserted into the vagina for treatment of pelvic organ prolapse or stress urinary incontinence. They are adequate treatment options for patients who are poor surgical candidates, those who decline surgical intervention, or as a temporizing measure in those ultimately planning surgery. Most studies suggest that about 75% of patients are able to be successfully fit with a pessary, but about 50% discontinue pessary use within 12 months of initiation. The purpose of this study is to determine why pessaries are discontinued.

NCT ID: NCT05981443 Recruiting - Surgical Wound Clinical Trials

An Analysis of Dermabond vs. Non-Absorbable Sutures in Skin Closure for Brow Ptosis Procedures

Start date: August 15, 2023
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT05978414 Recruiting - Clinical trials for Endometriosis-related Pain

Functional Links Between the Temporomandibular Joint and the Pelvis in Gynecology

TMJ and Pelvis
Start date: November 14, 2023
Phase: N/A
Study type: Interventional

1 Recruitment. 2. Collection of written consents for the study. 3. Random assignment to groups with and without intervention. 4. Completion of questionnaires by study participants, postural pattern assessment, temporomandibular joint assessment, and platform assessment. 5. Performance of visceral therapy in the group with intervention, in the group without intervention placebo. Duration 5 weeks, treatment 1x per week at the same time of day and given day e.g. Mondays only. 6. Reassessment as in step 4. 7. Data collection, statistical analyses. 8. Interpretation of results for female participants. 9. Preparation of results for scientific publications.

NCT ID: NCT05964881 Recruiting - Clinical trials for Pelvic Organ Prolapse

PDS Versus Prolene as Suture Material for Vaginal Sacrospinous Hysteropexy

Start date: May 15, 2023
Phase: N/A
Study type: Interventional

Introduction: Pelvic organ prolapse is a common gynecological disease, which about 50% of women develop in the course of their lives. There are many different options for surgical care, e.g. the uterus-preserving sacrospinal fixation (= sacrospinal hysteropexy = SSHP). This technique has been increasingly used in recent years. However, there is still no data on whether the fixation sutures should be performed with absorbable or non-absorbable threads. Internationally, both types of threads are routinely used and both types of threads are described in publications. So far, there is no comparative data on the effectiveness and subjective results. The aim of this study is to compare subjective symptom improvement Materials & Methods: This is a randomized, single-center superiority study. The sacrospinal fixation is performed according to a standardized method and two different types of threads (absorbable PDS sutures vs. non-absorbable Prolene sutures) are used for the fixation suture. Patients are randomized to either the absorbable PDS sutures group or the non-absorbable Prolene sutures group. The primary outcome of interest is the subjective symptom improvement 12 months after surgery (evaluated using the German version of the pelvic floor questionnaire). Secondary outcome variables are anatomical outcomes, condition-specific quality of life, and adverse events. 52 patients will be included in the study. The results of the study will be published in peer-reviewed journals and the results will be presented at scientific meetings.

NCT ID: NCT05960292 Recruiting - Clinical trials for Vaginal Vault Prolapse

Laparoscopic Versus Vaginal Approach Closure Complications

Start date: August 1, 2023
Phase: N/A
Study type: Interventional

Hysterectomy is considered as a common operation in Gynecology. Hysterectomy could be made by vaginally, laparoscopically or abdominally. The American Congress of Obstetricians and Gynecologist advises the use of a minimally invasive technique for the sake of women and to decrease hospital stay and costs.

NCT ID: NCT05938881 Recruiting - Clinical trials for Pelvic Organ Prolapse

Long-term Success Rate of Transvaginal Mesh for the Treatment of Pelvic Organ Prolapse: The Extended RCT Study

Start date: June 29, 2023
Phase:
Study type: Observational

The original RCT 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 at 1-year follow-up. This study will follow women in the original RCT study for up to 10 years from the time of the surgery to compare success and complication rates in the two groups. Recruitment into this study is open only to women that already participated in previous RCT, no new treatment interventions will be given. Recruitment into the previous RCT is closed. Women will be strongly encouraged to participate in annual examinations and annual telephone surveys but may participate in only one of these study parts if needed.

NCT ID: NCT05930795 Recruiting - Clinical trials for Patients With Pelvic Organ Prolapse

Comparison of Laparoscopic Pectopexy and Laparoscopic Lateral Suspension Surgeries

Start date: August 10, 2022
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT05918367 Recruiting - Surgery Clinical Trials

Multicenter Ventral Mesh Rectopexy Registry Collaborative

M2R2
Start date: September 25, 2023
Phase:
Study type: Observational [Patient Registry]

The goal of this multicenter observational study is to collect data prospectively of patients with pelvic organ prolapse undergoing ventral mesh rectopexy (as well as rectoceles, entero-/sigmoidoceles/ intussusception/ rectal prolapse or combined) by laparoscopy or robotic surgery and to evaluate the longterm functional outcomes. Secondly complications (mesh erosions, recurrence, reoperations) are evaluated. Following main questions will be analysed - other can follow in consultation with the collaborative 1. Is VMR the technique of choice for treatment of rectoceles? Functional results - recurrence - mesh related complications 2. Has a perineal descent an impact on the functional outcome of ventral mesh rectopexy perfored for external rectal prolaps, internal rectal prolaps, rectocele, enterocele, sigmoidcele or combined pelvic organ prolapse?

NCT ID: NCT05910021 Recruiting - Clinical trials for Urinary Incontinence

Early Safety of Resection Recopy and Sacrocolpopexy

RRPSCPcomb
Start date: February 1, 2020
Phase:
Study type: Observational

Obstructive defecation syndrome (ODS) defines a disturbed defecation process frequently associated with pelvic organ prolapse (POP) in women. It substantially compromises quality of life and conservative treatment options are limited. In cases surgery is required the interventions are characterized by individual approaches. Laparoscopic resection rectopexy (L-RRP) combined with laparoscopic sacrocolpopexy (L-SCP) was established in an interdisciplinary setting.