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Prolapse clinical trials

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NCT ID: NCT05812859 Enrolling by invitation - Clinical trials for Pelvic Organ Prolapse

Vaginal Orthosis Use After Vaginal Reconstructive Surgery

NOVa
Start date: January 29, 2024
Phase: N/A
Study type: Interventional

A novel vaginal orthosis, or splint, made of silicone will be used daily to help support the healing vaginal reconstruction during the post-operative phase from week 2 to week 12.

NCT ID: NCT05728554 Enrolling by invitation - Rectal Prolapse Clinical Trials

Breakthrough Improvement Collaborative for Ventral Mesh Rectopexy

BIC4VMR
Start date: March 1, 2023
Phase:
Study type: Observational

Different studies showed large variation between care processes in multiple diseases, this leads to large variation in outcomes. Better adherence to evidence-based guidelines for these diseases can reduce this variation and can improve the health outcomes. Ventral mesh rectopexy has gained popularity in Europe to treat different rectal prolapse syndromes. This procedure has been shown to achieve acceptable anatomic results with low recurrence rates, few complications, and improvements of both constipation and fecal incontinence. However, there is limited data on the care process and outcomes. Moreover, there is no insight in the variation between different centers for patients undergoing ventral mesh rectopexy. This study aims to map the variation in care for patients undergoing ventral mesh rectopexy in Flemish hospitals and to get an overview about the variation within and between these hospitals. Hereby, this will be a repeat of the studies for colorectal cancer, fragility hip fractures, stroke and breast cancer surgery.

NCT ID: NCT05658887 Enrolling by invitation - Clinical trials for Pelvic Organ Prolapse

Preoperative Gabapentin vs Placebo for Vaginal Prolapse Surgery

Start date: January 1, 2023
Phase: Phase 4
Study type: Interventional

This study will recruit women scheduled to undergo vaginal apical suspension surgery (either uterosacral ligament suspension or sacrospinous ligament fixation) with or without other prolapse or anti-incontinence procedures. Participants will be randomized 1:1 to preoperative gabapentin or preoperative placebo (both patients and investigators will be blinded). Note the control group will receive preoperative acetaminophen/celecoxib/placebo and the treatment group will receive preoperative acetaminophen/celecoxib/gabapentin (preoperative acetaminophen/celecoxib are part of our current ERAS protocol). The primary outcome will be postoperative opioid use in the first 24 hours postoperatively measured in morphine milligram equivalents.

NCT ID: NCT05569980 Enrolling by invitation - Quality of Life Clinical Trials

The Nordic Rectal Prolapse Study

NORDIC
Start date: April 1, 2023
Phase:
Study type: Observational

The goal of this observational study is to gather data about surgical procedures for rectal prolapse in adult human subjects. The main question it aims to answer is: • Which procedure is best for treating external rectal prolapse? Participants will: - be included if they can consent to participation - be offered standard care treatment, as no interventions will be done - be asked to answer relevant questionnaires within 3 months prior to the surgery for rectal prolapse - be asked to answer the same questionnaires 6 and 12 months postoperative - optionally answer the questionnaires again at 3 and 1 year postoperative, but this is not part of the existing funding body

NCT ID: NCT05513417 Enrolling by invitation - Clinical trials for Pelvic Organ Prolapse

Digital Care Programs for Female Pelvic Health

Start date: August 29, 2022
Phase:
Study type: Observational [Patient Registry]

The purpose of this study is to create a research repository, composed of data collected in the course of digital care programs for pelvic health conditions by SWORD Health/Bloom to individuals undergoing those programs. This will allow the investigators to observe the acceptance, engagement and outcomes of programs using this approach in the treatment of multiple pelvic health disorders.

NCT ID: NCT04539782 Enrolling by invitation - Clinical trials for Pelvic Organ Prolapse

A Feasibility Study on the Value of Pelvic Floor Training After Pelvic Organ Prolapse Surgery

Start date: June 10, 2020
Phase: N/A
Study type: Interventional

The main objective is to assess the feasibility of a randomized controlled trial that investigates the effects of pelvic floor training on recurrence in pelvic organ prolapse surgeries. This will be achieved by measuring POP-Q stage and by a validated questionnaire before surgery and one year after. Women having POP surgery at Landspitali will be offered to participate if they meet the criteria of the research. Participants will be randomized into two groups, interventions and control group that gets standard care at the hospital. The intervention group will meet a physiotherapist 6 weeks post-op for targeted physiotherapy with pelvic floor training, conventional advice and support. Over 16 weeks period participants in intervention group will get physiotherapy four times and get two follow up phone calls. Pelvic floor activity will be measured with EMG and symptoms collected with questionnaire before surgery and year post-op. Recurrent surgeries are common problem shortly after the first one. POP symtoms can be bothersome for women and reduce their quality of life. More knowledge is needed to figure out if targeted physiotherapy with pelvic floor training can help reduce recurrency and bothersome symptoms.

NCT ID: NCT04378400 Enrolling by invitation - Clinical trials for Vault Prolapse, Vaginal

An Institutional Audit of the Short Term Complications and Long Term Outcomes of Patients Undergoing Laparoscopic Sacrocolpopexy for Vault/Cervical Prolapse.

Start date: September 29, 2020
Phase:
Study type: Observational [Patient Registry]

An institutional audit of the short term complications and long term outcomes of patients undergoing laparoscopic sacrocolpopexy for vault/cervical prolapse.

NCT ID: NCT04067635 Enrolling by invitation - Clinical trials for Mitral Regurgitation

Primary Mitral Regurgitation Repair

Start date: May 25, 2018
Phase:
Study type: Observational

This longitudinal cohort study evaluates the relationship of myocardial tissue markers characteristics assessed by cardiac MRI, with clinical measures of symptoms and functions in adults with primary mitral regurgitation. Participants are followed conservatively or may choose to undergo surgical repair at the discretion of their clinical team.

NCT ID: NCT03916107 Enrolling by invitation - Ptosis, Eyelid Clinical Trials

Comparison of Different Surgical Treatments for Severe Ptosis Correction

Start date: January 1, 2018
Phase: N/A
Study type: Interventional

Main research purposes of this research is to compare the therapeutic effect and safety of the superior levator muscle shortening combined with the tarsus resection and the traditional frontal muscle flap in the correction of severe ptosis. Aside of above we also tend to explore the dose-effect relationship between the amount of levator muscle shortened/ tarsus resection and postoperative ptosis correction amount.So as to develop a more critical and specific guidelines for clinical treatment of ptosis. So during the research we will recruiting patients with severe ptosis and randomly divide them into levator muscle and tarsus group and frontal muscle flap group, and follow up those patient 6 months post operation so as to evaluate the amount of correction and the side-symptoms.

NCT ID: NCT03700593 Enrolling by invitation - Rectal Cancer Clinical Trials

Feasibility and Safety of Single Port Robot in Colorectal Procedures

Start date: October 15, 2018
Phase:
Study type: Observational [Patient Registry]

The purpose of this study is to evaluate the safety and feasibility of using the Single Port (SP) robot (daVinci, Intuitive Surgical) to perform single port robotic colon surgery and transanal robotic surgery. The hypothesis of the study is that the SP robot will prove a safe effective modality to perform these procedures.