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Surgery clinical trials

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NCT ID: NCT05230771 Not yet recruiting - Surgery Clinical Trials

Clinical Outcome of Palliative Surgery After Translational Therapy for Metastatic Gastric Cancer Versus Maintenance Chemotherapy for Metastatic Gastric Cancer

Start date: April 1, 2022
Phase: Phase 3
Study type: Interventional

This single-center, prospective study was conducted to investigate the efficacy and safety of palliative surgery after translational therapy in the treatment of metastatic gastric cancer. The primary endpoint was 2-year overall survival (OS) rate. Secondary endpoints were median OS, progression-free survival (PFS), 1-year OS, adverse events (AE), severe AE, the quality of life (QOL) and treatment cost.

NCT ID: NCT05230264 Not yet recruiting - Surgery Clinical Trials

Sex-specific Differences in the Stress Response to Abdominal Aortic Aneurysm Repair

SSStressAAA
Start date: February 1, 2022
Phase:
Study type: Observational

It is recognised that women are at greater risk of death, complications and longer hospital stay following intact abdominal aortic aneurysm (AAA) repair, and the reason for this is not yet established. This disparity in outcomes for women compared to men is also recognised in other forms of cardiovascular surgery, which raises the question of whether women and men are reacting differently to the stress of operative repair. This study aims to examine whether there are differences baseline stress markers and in the stress response to AAA repair between men and women. It will also examine whether markers of stress are associated with poor clinical outcomes and slower recovery (indicated by longer hospital stay). The study will take the form of an observational cohort study. It will not alter any of the treatment that men and women receive, but will monitor their stress levels using physiological markers (through ECG (electrocardiogram) monitoring using a non-invasive holter, biochemical markers using blood samples (which will be taken at the same time as routine testing, so as not to require further invasive procedures), and psychological testing, using short forms that the patient will be able to fill out independently at different stages of their recovery. Clinical data will be used to look for relevant factors (clinical history or medications) which may alter the stress markers we are observing, and to compare outcomes with markers of stress. Patients will be asked for their consent to share their data with the research team in order to participate in the study. It will be made clear that there will be no change in their clinical or operative management if they participate in the study and they will be able to withdraw consent for further participation at any time.

NCT ID: NCT05227430 Not yet recruiting - Surgery Clinical Trials

Standardized Educational Videos of Laparoscopic Gynecological Surgeries

AA-GYNLAP
Start date: February 2024
Phase: N/A
Study type: Interventional

Owing to coronavirus disease-related social distancing requirements, online education has gained prominence. Surgical trainers consider online videos as a useful teaching aid that maximizes trainees' learning and skill development given the backdrop of time constraints and productivity demands, however, online videos usually do not undergo a peer-review process. Based on these premises the LAP-VEGaS guidelines (LAParoscopic surgery Video Educational GuidelineS), a recommended checklist for production of educational surgical videos, were developed. This study aime to evaluate the impact of educational videos of laparoscopic gynecological surgeries, that were standardized with the LAP-VEGaS, for the improvement of surgical confidence and performance of surgical trainees.

NCT ID: NCT05227235 Not yet recruiting - Surgery Clinical Trials

Clinical Trial of 3D Telemedicine

Start date: August 1, 2022
Phase: N/A
Study type: Interventional

This randomised controlled trial will provide definitive answers to whether a 3D telemedicine system makes a remote consultation more similar to meeting a doctor face-to-face, than a 2D Telemedicine consultation. This will be measured using a "Presence" scale - which is a measure of the realism or immersion of the system - and is of key importance as preliminary data from the research team's feedback studies found that realism of a clinical consultation correlates strongly with patient satisfaction. Patient satisfaction is seen by many healthcare systems as primary evidence of efficacy of treatment and as a strong determinant of overall health outcomes. Further outcome measures in this trial will assess patient satisfaction, usability, and mental effort.

NCT ID: NCT05161299 Not yet recruiting - Surgery Clinical Trials

CovidSurg-3: Outcomes of Surgery in COVID-19 Infection

CovidSurg-3
Start date: December 13, 2021
Phase:
Study type: Observational

COVID-19 has significant detrimental impacts on surgical systems and patient outcomes. CovidSurg has provided the best available evidence to guide delivery of safe surgery during the pandemic. However, CovidSurg data were collected in 2020 when the wildtype SARS-CoV-2 virus was dominant, and therefore there is a need to for renewed rapid data to guide global practice during Omicron COVID-19 waves. CovidSurg-3 is an extension to CovidSurg and was initiated in response to the emergence of the Omicron variant. CovidSurg-3 has two separate components: - Patient-level component: Collection of outcome data for patients with peri-operative SARS-CoV-2. - Hospital-level component: Collection of aggregated case-mix data. Hospitals in countries with low community SARS-CoV-2 infection rates can contribute towards this component.

NCT ID: NCT05134610 Not yet recruiting - Surgery Clinical Trials

Effect of Perioperative OPEP Therapy on Post-operative Pulmonary Complications

Start date: March 2022
Phase: N/A
Study type: Interventional

For patients undergoing colorectal surgery, post-operative pulmonary complications (PPCs) are common. PPCs are associated with increased morbidity and mortality, as well as prolonged hospital stays and healthcare costs. Pulmonary exercise in the pre-operative setting is thought to improve pulmonary fitness and decrease incidence of PPCs. Use of an oscillating positive expiratory pressure (OPEP) device sees patients improve their respiratory fitness through prescribed usage of a handheld instrument that exercises pulmonary muscles while breathing. Here, the investigators propose a pilot randomized-controlled trial (RCT) to evaluate the feasibility of a large scale study that would examine the effect of preoperative OPEP device exercises in preventing PPCs for patients undergoing elective colorectal surgery.

NCT ID: NCT05125393 Not yet recruiting - Surgery Clinical Trials

Evaluation the Safety of Indocyanine Green Guided Treatment of Henle Trunk

SIGHELC
Start date: December 1, 2021
Phase: N/A
Study type: Interventional

Laparoscopic right hemicolectomy D3 dissection or complete mesocolic excision (CME) has become the standard treatment for right hemi-colon cancer, and the treatment of Henle trunk is one of the difficulties of the operation. However, there are many variations in the Henle trunk, and the vein wall is thin. It is very easy to damage the Henle trunk and its branches during the operation, resulting in massive bleeding, especially for beginners. In addition, retrospective studies found that for ileocecal or ascending colon tumors, low ligation of Henle trunk can obtain better lymph node clearance. In the early stage, the investigators improved the surgical method for ileocecal or ascending colon tumors. An endoscopic linear stapler was used to disconnect the surrounding tissues of Henle trunk under the guidance of indocyanine green developer. The retrospective study of small samples found that it can significantly reduce the incidence of local bleeding, shorten the operation time, and obtain the same lymph node clearance rate. At present, there is less large-scale randomized controlled study on the disconnection of Henle trunk with linear stapler for right colon cancer. In recent years, the were nearly 1000 cases/year of colorectal cancer operated in department of gastrointestinal surgery of shanghai east hospital. Therefore, the investigators plan to cooperate with many domestic colorectal cancer treatment centers to take the lead in carrying out this prospective, multicenter and randomized controlled trail, to explore the safety and efficacy of linear stapler in the treatment of Henle trunk in laparoscopic radial hemicolectomy of colon cancer. The investigators hope to provide accurate clinical evidence for individualized precision treatment of rectal cancer patients.

NCT ID: NCT05049707 Not yet recruiting - Surgery Clinical Trials

Does Perioperative Intravenous Magnesium Affect Postoperative Quality of Recovery in Craniotomy Surgery Patients?

Start date: November 1, 2024
Phase: Phase 3
Study type: Interventional

Perioperative pain management for craniotomy patients may be challenging because the commonly used agents such as opioids, gabapentin, and dexmedetomidine also cause sedation, which can confound the neurological exam and can lead to respiratory depression and increased intracranial pressure. Preoperative intravenous magnesium boluses and infusions have previously been established as an effective, nonsedating analgesic that can reduce opioid consumption 25-30% up to 48 hours postoperatively. However, intravenous magnesium has not seen widespread use in craniotomy patients due to concerns for interference with the neurological monitoring that commonly occurs in these cases. Intravenous magnesium given as a bolus preoperatively or as a constant infusion may avoid these problems and has never been investigated. The goal of this study is to compare intravenous magnesium given preoperatively and intraoperatively to placebo in adult elective craniotomy patients to improve quality of recovery postoperatively, and evaluate safety and tolerability. Secondary endpoints will include evaluating for pain, sedation, agitation, blood pressure, and opioid consumption postoperatively.

NCT ID: NCT05039333 Not yet recruiting - Gastric Cancer Clinical Trials

Clinical Study to Prove Safety and Effectiveness When Applying RUS™ Surgical Navigation

Start date: September 1, 2021
Phase:
Study type: Observational

By uploading pre-operative patient information and patient CT data to RUS™, a virtual surgical environment with patient-specific relief prediction models can be provided. First, after uploading the CT and clinical information of a gastric cancer patient diagnosed with gastric cancer through an actual endoscopic biopsy and scheduled for robotic total gastrectomy, RUS™ will operate normally to check whether patient-specific surgical navigation is available before or during surgery. In particular, when using the patient-specific surgery simulation system provided by RUS™, the CT information provides a patient-specific 3D environment well, so it will be checked regarding whether the surgeon can use it before or during surgery without any particular problems. Using RUS™ software, navigation information is used before or during surgery, and among these, parts that can be quantitatively compared with actual measurements will be evaluated as a secondary research goal. After the surgery, the investigators plan to check the amount of bleeding, duration of hospitalization, and the rate of complications by performing robot gastrointestinal resection using the navigation system to ensure that there are no problems with patient safety.

NCT ID: NCT04968704 Not yet recruiting - Surgery Clinical Trials

Computer Modelling to Plan Surgical Reconstruction

Start date: October 1, 2021
Phase:
Study type: Observational

The aim of this study is to improve patient satisfaction and outcomes in facial reconstructive surgery by using 3D clinical photography and computer modelling to help illustrate and plan the patients' reconstructive journey. It will be conducted at the Royal Free Hospital department of Plastic and Reconstructive Surgery, where patients with facial deformities or suspected diagnoses of skin cancer will be referred from their GP or dermatology services. As is routine standard of care, they will be reviewed in outpatient settings and the next management steps initiated. Our study will introduce compulsory 2D and 3D photography and patient satisfaction questionnaires. The photographs will be used to sit down with the participant and illustrate the intended surgical reconstruction, keeping them up to date and fully informed of the surgical plan. The questionnaire, FACE-Q, already validated for facial skin cancer surgery and reconstruction, will be used to assess their satisfaction at each stage of their reconstructive journey. The results of the study will benefit each participant and illustrate an improvement in satisfaction so that such 3D photography, surgical planning with computer models produced by these 3D images will become a routine part of future patients with facial disfigurement or cancer requiring reconstruction. This study will form part of a PhD academic qualification at UCL for one of the research registrars.