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NCT ID: NCT04095845 Active, not recruiting - Surgery Clinical Trials

Conventional Total Hip Arthroplasty vs Mako Robotic-arm Assisted Total Hip Arthroplasty

Start date: November 9, 2018
Phase: N/A
Study type: Interventional

The overall aim of this single-centre, prospective randomised controlled trial is to compare clinical, functional, and radiological outcomes in CO THA versus Mako THA. Patients undergoing Mako THA will form the investigation group and those undergoing CO THA will form the control group.

NCT ID: NCT04074382 Active, not recruiting - Surgery Clinical Trials

FIT Study (Functional Outcomes In Trauma Study)

Start date: August 10, 2020
Phase:
Study type: Observational [Patient Registry]

Why? There is not much information in the UK on how well patients who sustain major trauma function afterwards. Major trauma is defined as significant injuries with a calculated 'injury severity score' (ISS) over 15. The ISS is calculated based on how many parts of the body are injured and how badly injured these are, up to a maximum score of 75 (fatal). We feel that learning more about how these people cope afterwards, and what influences this will allow us to improve the care we can deliver in the future, which will hopefully lead to better outcomes. What? We propose to implement the FIT (Functional outcomes In Trauma) study to assess how well patients function physically, psychologically and socially, and get back to activities of daily living, work and participation in recreational activities following major trauma. Who? Major trauma patients: 2 cohorts: prospectively going forwards in time (from baseline to 12 months after trauma) and retrospectively going backwards in time (patients between 2-10 years after trauma). Where? Leeds General Infirmary. How? We will do this by collecting data from questionnaires completed by patients (also known as PROMS, or Patient Reported Outcome Measures), using an online questionnaire service developed at the University of Leeds, called QTool. These will offer the participants the chance to tell us how they are doing across lots of areas, with both tick-box multiple choice questions and open-ended questions to explain how they are doing and what influences this. We will also interview a random selection of patients in further detail to discuss how their trauma has affected them, how they found the study, how we could improve it. Afterwards we will send participants a copy of what we have learnt from the study and aim to publish it in a scientific journal. Timeline/Phase overview: The FIT Study will consist of 2 phases. Phase 1 will last for 2 years in total (12 months for prospective study cohort recruitment and 12 months follow-up for these patients) during which time data will be collected from the retrospective cohort as well. Following this there will be a full analysis of the data, after which phase 2 of the FIT Study will begin. Patients enrolled into phase 1 of the study will be given the option of consenting to being contacted annually to complete the same set of online PROMs, which will comprise phase 2 of the study. We will also continue active recruitment into both prospective and retrospective arms of the study in phase 2. We plan to continue data collection on an annual basis up to 10 years post trauma in phase 2 of the study for patients in both cohorts. We hope to incorporate elements of the FIT Study into future routine care with what we learn from the FIT Study, and develop our own unique Patient Reported Outcome Measure tool, with the overall aim of improving patient care and outcomes.

NCT ID: NCT04061798 Active, not recruiting - Surgery Clinical Trials

ACT Guided Heparinization During Open Abdominal Aortic Aneurysm Repair.

ACTION-1
Start date: March 2, 2020
Phase: Phase 4
Study type: Interventional

Aim of the ACTION-1 study is to determine whether ACT guided heparinization decreases thrombo-embolic complications (TEC) and mortality after elective open AAA surgery, without causing more bleeding complications.

NCT ID: NCT03938571 Active, not recruiting - Obesity Clinical Trials

Standard Duodenal Switch vs. Single Anastomosis Duodeno-Ileostomy Duodenal Switch

Start date: August 2016
Phase: N/A
Study type: Interventional

The aim of the Torsby I Trial is to identify differences and similarities between a standard duodenal switch (DS) and a single-anastomosis duodeno-ileostomy (SADI) regarding effect on weight, comorbidities and malnutrition.

NCT ID: NCT03870919 Active, not recruiting - Surgery Clinical Trials

Locoregional Treatment and Palbociclib in de Novo, Treatment Naive, Stage IV ER+, HER2- Breast Cancer Patients

PALATINE
Start date: October 23, 2019
Phase: N/A
Study type: Interventional

Approximately 3.5% to 6% of newly diagnosed breast cancer patients are stage IV metastatic. De novo metastatic breast cancer accounts for 20% to 25% of these cases. Despite a decrease in mortality in Europe and North America due to early detection and access to treatment, breast cancer remains the 2ⁿᵈ leading cause of cancer deaths in developed countries after lung cancer and the world's leading cause. In the ESME French national retrospective cohort (NCT03275311), the newly diagnosed estrogen receptor (ER)-positive and HER2-negative (luminal) metastatic patients had a 59.1 months overall survival (OS) for pre-menopausal women and 44.7 months for postmenopausal women. In the same cohort, the median OS was 47.4 months for de novo metastatic patients with hormone receptor (HR)-positive / HER2-negative breast cancer. The most important current treatment for metastatic breast cancer remains systemic therapy. Surgery and radiation are mainly used to treat symptoms. However, more than 15 retrospective studies have assessed the impact of locoregional treatment on relapse and OS. These studies suggested an improvement of the OS in patients with de novo metastatic breast cancer thanks to the addition of locoregional treatment to systemic therapy. Recent data from the ESME cohort suggest that patients with de novo luminal or HER2-positive metastatic breast cancer may benefit from local treatment of the primary tumor. Several prospective trials have attempted to demonstrate the benefit of locoregional treatment with mixed results. This can be explained by a limited power of statistical analysis, on the recruitment of patients with breast cancer of all types, and on a limited access to effective systemic therapies in some cases and all before the area of anti CD4/6 which is the current standard treatment in patients with HR-positive / HER2-negative luminal metastatic disease. However, guidelines indicate that a "multimodal approach, including curative locoregional treatments, should be considered". As a result, many clinicians offer locoregional treatment of the primary tumor, especially if there is a good response to the first line of systematic treatment. Taken together, these data underscore the need for an evaluation of the value of combined therapy - endocrine therapy - CDK4/6 inhibitor and locoregional treatment - in this population of patients with newly diagnosed HR-positive / HER2-negative breast cancer.

NCT ID: NCT03862456 Active, not recruiting - Surgery Clinical Trials

Metronidazole vs Azithromycin in Periodontal Surgery for Patients Positive to Porphyromonas Gingivalis

Start date: January 2013
Phase: N/A
Study type: Interventional

The objective of this study is to determine whether, in patients with non treated periodontitis (stage III and IV) positive to Porphyromonas gingivalis, the use of systemic antimicrobials (metronidazole versus azithromycin) as an adjunctive treatment to periodontal surgery provides clinical and microbiological benefits.

NCT ID: NCT03761459 Active, not recruiting - Surgery Clinical Trials

Current Surgical Practices and Surgical Site Infection at Ayder Comprehensive Specialized Hospital in Mekelle, Ethiopia

Start date: March 20, 2018
Phase:
Study type: Observational [Patient Registry]

This study evaluates the current surgical practices at Ayder Comprehensive Specialized Hospital in comparison to the World Health Organization's Surgical Unit Based Safety Programme guidelines and aims to determine how deviations from those guidelines are associated with varying rates of surgical site infection incidence in this population. The results of this study will help elucidate risk factors for surgical site infection and prioritize future interventions to decrease the rate of surgical site infection at Ayder Comprehensive Specialized Hospital, as well as other low and middle-income hospitals. The data collected regarding surgical site infection rates will also prove beneficial in measuring outcomes of any interventions that are developed as a result of this study.

NCT ID: NCT03636568 Active, not recruiting - Surgery Clinical Trials

Hyponatremia Study (Delayed Hyponatremia After Pituitary Surgery)

DHAPS
Start date: June 2, 2016
Phase: N/A
Study type: Interventional

Hyponatremia is defined as sodium below the normal range of 135-145. Symptomatically, it can cause patients to experience a wide range of symptoms including lethargy, headache, nausea, vomiting and in severe cases coma and even death. The goal of this study is to prospectively compare two approaches to the postoperative fluid management of patients undergoing transsphenoidal resection of a pituitary tumor or cyst to decrease the occurrence of postoperative delayed hyponatremia. One group will be placed on moderate fluid restriction and the other group will be placed on ad lib fluid intake.

NCT ID: NCT03567538 Active, not recruiting - Lung Cancer Clinical Trials

National Register Studies in Thoracic Surgery

Start date: January 1, 2018
Phase:
Study type: Observational

The overall project aim is to study risk and outcomes following thoracic surgery by cross-linking high-quality national Swedish health-data registers for population-based investigations of individual level clinically relevant patient data.

NCT ID: NCT03480399 Active, not recruiting - Quality of Life Clinical Trials

Long Term Morbidity and Quality of Life in Retroperitoneal Sarcomas

LTM
Start date: January 2014
Phase:
Study type: Observational

No prospective data exist about long term morbidity and quality of life after multivisceral surgical resection for retroperitoneal soft tissue sarcoma (RSTS). In order to assess the safety of this surgical approach and the effect on the Quality of Life over the long period we propose a prospective observational study. The hypothesis is that the surgical treatment has no significant impact in determining a lower Quality of Life in the long term. Objectives Primary objective Estimate the difference between baseline and 4 and 12 months scores of the "global health status / QoL" scale in patients primarily treated for localized RSTS, as determined in QLQ-C30 version 3.0. Secondary objectives - Evaluate the long term morbidity of aggressive surgical approach to RSTS in terms of renal failure. - Evaluate the difference between baseline and 4 and 12 months scores of DN4 / LEFS / BPI questionnaires. - Evaluate the difference between baseline and 4 and 12 months scores of the following scales from QLC-C30: PF2, RF2, EF, CF, SF, FA, FI. - Evaluate the difference between baseline and 4 and 12 months scores of the following scales and single items from QLC-C29: Blood and mucus in stool, Stool frequency, Sexual interest, Impotence, Dyspareunia. - To correlate the surgical resection pattern (number and type of organs resected) and the tumor features (size, grading and histological subtype) with the long-term morbidity and quality of life. Eligibility Inclusion criteria - Adult patients (age > 18 years) with primary localized RSTS surgically treated at our institution - Written, voluntary, informed consent Exclusion criteria - Recurrent disease