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Surgery clinical trials

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NCT ID: NCT04934345 Not yet recruiting - Surgery Clinical Trials

EFFECT OF VASOPRESSORS ON FLUID CHALLENGE PERSISTENCE AN OBSERVATIONAL STUDY IN PATIENTS UNDERGOING LAPAROTOMY.

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

The hemodynamic effect of the fluid challenge administration (FC) depends on different variables related to the interplay between cardiac function and vascular tone response. In this context, the effect of adding a vasopressor to keep the arterial pressure between predefined ranges may impact on the persistence of stroke volume (SV) changes after FC administration. In fact, both the effect on arterial elastance and venous return may increase the persistence of SV increase, which is know to drop to baseline pre-FC values within fw minutes after FC administration. This single-centre observational study, in elective patients scheduled for elective laparotomy, hypothesizes that intraoperative norepinephrine infusion would prolong the effect of FC administration.

NCT ID: NCT04893876 Not yet recruiting - Quality of Life Clinical Trials

The OPERa Study: Evaluating QoL After Rectal Cancer Surgery

Start date: January 1, 2023
Phase:
Study type: Observational [Patient Registry]

Advances in rectal cancer management have significantly reduced morbidity and mortality. The most commonly performed operation for rectal cancer is restorative proctectomy (RP), leaving up to 70% with long-term bowel dysfunction called Low Anterior Resection Syndrome (LARS). LARS manifests as stool frequency, incontinence and difficult defecation. LARS, along with other functional impairments such as sexual and urinary dysfunction (SUD), can impact quality of life (QoL) and cause emotional distress. High-quality longitudinal data on these sequalae are lacking, leading to variable estimates of their prevalence, risk factors and prognosis. Most studies are European, cross-sectional, lack pre-treatment evaluation and long-term follow-up, and use inconsistent assessment measures. Thus, a North American study that evaluates patients longitudinally from diagnosis will provide quality data to fill this knowledge gap. The main aim of the proposed study is to contribute evidence regarding the impact of LARS, SUD, emotional/financial distress, and patient activation on long-term post-treatment QoL in North American rectal cancer after RP. This multicenter North American, observational, prospective cohort study relies on validated patient reported outcome measures (PROMs) at diagnosis, during and post-treatment. Patients from 20 sites will be recruited over 2 years and followed for 3 years. The primary endpoint is QoL as measured by the European Organization for Research & Treatment of Cancer QoL questionnaire. We anticipate accrual of 1200 patients. Factors associated with QoL will be explored. Impact of patient activation in relation to functional outcomes on QoL over time will be explored using a difference-in-differences approach. The study involves a multidisciplinary team who will provide expertise in research methodology, nursing, oncology and surgery. The main contributions of this study are 1) provision of reference baseline North American values for important rectal cancer PROMs for clinical and research use, 2) an understanding of the evolution of functional outcomes and QoL post-treatment to counsel patients peri-operatively and throughout survivorship, and 3) to provide the basis for future tailored programs to support rectal cancer survivors.

NCT ID: NCT04876950 Not yet recruiting - Surgery Clinical Trials

Post Discharge After Surgery Virtual Care With Remote Automated Monitoring Technology (PVC-RAM) -2 Trial

PVC-RAM-2
Start date: June 2024
Phase: N/A
Study type: Interventional

The Post discharge after surgery Virtual Care with Remote Automated Monitoring technology (PVC-RAM)-2 Trial is a multicentre, parallel group, superiority, randomized controlled trial to determine the effect of virtual care with remote automated monitoring (RAM) technology compared to standard care on acute-hospital care during the 30-day follow up after randomization, in adults who have undergone semi-urgent (e.g., oncology), urgent (e.g., hip fracture), or emergency (e.g., ruptured abdominal aortic aneurysm) surgery. Secondary outcomes at 30 days after randomization include 1) hospital re-admission; 2) emergency department visit; 3) medication error detection; 4) medication error correction; and 5) surgical site infection. Additional secondary outcomes are pain of any severity, and moderate-to-severe pain assessed at 7, 15, and 30 days. We will also assess optimal management of long-term health by evaluating among patients with atherosclerotic disease whether patients are taking classes of efficacious medications at 30 days.

NCT ID: NCT04868552 Not yet recruiting - Surgery Clinical Trials

Naloxone Education in Total Joint Patients

Start date: September 2021
Phase: N/A
Study type: Interventional

This study examines the efficacy of a brief pre-hospital naloxone education module added to the standard "Total Joint Class" curriculum on patient safety and experience. Participants will consist of 250 patient-and-support-person pairs. The primary outcome is "readiness to use" naloxone - a proxy for opioid overdose safety. Patient factors contributing to this primary outcome as well as the effect on patient attitude and experience will also be investigated.

NCT ID: NCT04859855 Not yet recruiting - Surgery Clinical Trials

Transfusional Trigger in Post-operative Oncologic Patients in Critical Care

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

Transfusional practices evolved significantly over the last decades, but there are still important controversies regarding triggers that should be adopted in different clinical scenarios. Most international guidelines recommend using a hemoglobin (Hb) level around 7,0-8,0g/dL as the value to prompt a transfusion of red blood cell concentrates (RBC). Critical care patients usually are in a hyperdynamic state, working with an elevated cardiac output and compromised organ function. In these patients, the dependency on the arterial content of oxygen is greater, making lower Hb levels more associated with organ disfunction and compromised homeostasis. With this study the investigators hope to help clinicians to make decisions regarding transfusion of RBCs in critical surgical patients, establishing a transfusional trigger, without exposing patients to unnecessary additional risks, in the scenario involving patients with cancer, in post-operative care. This is a prospective, randomized, controlled, interventional trial, with the aim of evaluating the impact of restrictive versus liberal transfusional strategy on mortality and severe clinical complications in post-operative oncologic critically ill patients. The primary outcome is mortality in 30 days. The interventions consist in transfusion of RBCs according to the allocation to a liberal or restrictive transfusional strategy. In the restrictive strategy arm patients will receive transfusion of RBCs if the Hb falls to a level equal to or below 7,0g/dL. In the liberal strategy arm patients will receive transfusions if Hb level is below or equal to 9,0g/dL. In both arms patients should receive only one unit of RBC per time, with measurement of Hb level after three hours to evaluate the need for additional units. The strategy should be maintained during intensive care unit (ICU) stay for a maximum of 90 days. In case of a permanence in the ICU for a period longer than 90 days, or if the patient is discharged from the ICU, the transfusional support will be determined by the assisting physicians, independently of the allocated study arm. If the patient returns to the ICU during the 90 days of randomization, then he should go back to receiving transfusions according to the liberal or restrictive strategy in use previously in the ICU.

NCT ID: NCT04853784 Not yet recruiting - Surgery Clinical Trials

Prospective Registration Study of Totally Laparoscopy Versus Laparoscopy Assisted Colon Cancer Surgery

STARS-CC01
Start date: May 1, 2021
Phase:
Study type: Observational [Patient Registry]

This is a comparison of totally laparoscopic and laparoscopic-assisted colon cancer resection, a prospective registration study comparing the safety and benefits of the two operations

NCT ID: NCT04845763 Not yet recruiting - Surgery Clinical Trials

Validation of the QoR-15 Score for Emergency Surgery

FQoR-15U
Start date: June 1, 2021
Phase:
Study type: Observational

Recovery from surgery is a complex process, depending on the characteristics of the patient, the anesthesia used, and the time required for surgical management. In the context of emergency surgery, the perioperative period is associated with an increase in morbidity and mortality, which may lead us to suspect an alteration in the quality of recovery. Different scales to measure the quality of post-operative recovery have been developed. The QoR-40 and QoR-15 questionnaires assess recovery after elective surgery.These scoring tools accurately measure postoperative recovery by addressing key domains: pain, physical comfort, physical independence, psychological support and emotional state. Their use is recommended as an endpoint for assessing patient comfort in clinical trials, according to the Standardized Endpoints in Perioperative Medicine (StEP) initiative. In addition, monitoring of the QoR-15 is recommended by the American Society for Enhanced Recovery. A recent French translation of the QoR-15 score has been validated for use in scheduled surgery. All of these scores, regardless of the language in which they are translated, have been developed and validated in patients who have undergone scheduled surgery. Until now, no validated scoring tool has been available to assess recovery after emergency surgery, whether traumatological or not.

NCT ID: NCT04845490 Not yet recruiting - Colorectal Cancer Clinical Trials

Comparative Study of Mitomycin and Lobaplatin in Advanced Colorectal Cancer Patients With Radical Surgery Combined With Hyperthermic Intraperitoneal Chemotherapy

WUHIPEC02
Start date: September 1, 2022
Phase: Phase 2
Study type: Interventional

This study is a prospective, randomized, comparative clinical trial conducted by Wuhan Union Hospital and aim to compare the therapeutic effects of Mitomycin and Lobaplatin in the treatment of advanced colorectal cancer patients with radical surgery combined with hyperthermic intraperitoneal chemotherapy

NCT ID: NCT04843189 Not yet recruiting - Surgery Clinical Trials

Prospective Registration Study of Robtic Laparoscopy Versus Laparoscopy Assisted Colon Cancer Surgery

STARS-CC02
Start date: May 1, 2021
Phase:
Study type: Observational [Patient Registry]

The purpose of this study is to compare the clinical data of patients with colon cancer who received robotic or laparoscopic surgery, and to compare the short-term and long-term effects of robotic surgery in the treatment of colon cancer. To verify the safety and effectiveness of the corresponding surgical methods, and provide better guidance for the following clinical practice.

NCT ID: NCT04820075 Not yet recruiting - Surgery Clinical Trials

Efficacy of an Intervention to Improve the Preoperative Shower in Scheduled Surgery

PRODOUCH'OP
Start date: September 1, 2023
Phase: N/A
Study type: Interventional

The aim of the project is to evaluate the effectiveness, on the skin cleanliness of the patient on arrival at the operating room, of an intervention aimed at improving the performance of the preoperative shower, for patients undergoing a planned surgical intervention in an orthopedic surgery department, digestive, gynecological, thoracic, or vascular.