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Surgery clinical trials

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NCT ID: NCT06232876 Not yet recruiting - Surgery Clinical Trials

Continuous Versus Intermittent Ward Monitoring

CONSTANT
Start date: July 1, 2024
Phase: N/A
Study type: Interventional

The investigators will randomize adults having major non-cardiac inpatient surgery to blinded versus unblinded continuous vital sign monitoring (saturation, ventilation, and heart rate) and hourly intermittent blood pressure recordings. The investigators will use a wearable, untethered, and battery-powered monitor (Masimo Radius VSM, Masimo, Irvine, CA) that continuously records saturation, ventilation, and heart rate, and intermittently records blood pressure. Our primary outcome will be areas-exceeding-thresholds for desaturation (<85%),3 bradypnea (<5 breaths/min), tachypnea (>25 breaths/min), tachycardia (heart rate >130 beats/min), bradycardia (heart rate <35 beats/min),4 mean arterial pressure (MAP) <65 mmHg, and MAP >145 mmHg. These exposure thresholds represent a balance between events that are clinically meaningful and excessive alarms that will discourage clinician participation. In unblinded patients, clinician alerts will be activated at these thresholds.

NCT ID: NCT06231576 Not yet recruiting - Surgery Clinical Trials

Digital Home-Based Prehabilitation Before Surgery

dHOPE
Start date: February 1, 2024
Phase: N/A
Study type: Interventional

This clinical trial compares two different prehabilitation programs, with no organized prehabilitation, prior to major colorectal cancer surgery. The prehabilitation programs include intensive and coached physical exercise and optimized nutritional intake coupled with smoking cessation, physiological support and correction of poly-pharmacy.

NCT ID: NCT06229197 Not yet recruiting - Surgery Clinical Trials

Billroth II With Braun Anastomosis After Radical Distal Gastrectomy for Gastric Cancer

Start date: February 1, 2024
Phase: N/A
Study type: Interventional

The primary aim of this trial is to rigorously evaluate the comparative benefits and potential risks associated with Billroth II reconstruction with Braun anastomosis versus Billroth II reconstruction alone following distal gastrectomy with D2 lymphadenectomy in patients diagnosed with gastric cancer. This assessment focuses on delineating the therapeutic efficacy, safety profile, and overall clinical outcomes of these two surgical approaches in treating this condition.

NCT ID: NCT06220253 Not yet recruiting - Surgery Clinical Trials

Comparison of Learning Curves for Two Different Techniques in Vaginal Hysterectomy

Start date: June 2024
Phase: N/A
Study type: Interventional

Randomized prospective monocentric interventional study to compare learning curves for traditional vaginal hysterectomy and vaginal hysterectomy performed by bipolar coagulation comparing short-term outcomes for both procedures.

NCT ID: NCT06210204 Not yet recruiting - Surgery Clinical Trials

Improving Access to Surgical Care: Safety, Efficacy, and Satisfaction With Postoperative Telehealth

Start date: January 2025
Phase: N/A
Study type: Interventional

Background: A quarter of US Veterans reside in rural communities and are significantly older than their urban counterparts. Providing timely access to care is especially important in this older, independent and medically complex cohort. Virtual care, by phone or video, has improved access to care in non-surgical specialties; however, its utilization in surgery is less than 10% and has continued to decline after the COVID pandemic. Recent studies in surgical patients have demonstrated no difference in missed adverse events, emergency department visits or readmissions; but these data are limited to routine, low-risk procedures in large, urban centers. Routine telehealth for low and high-complexity surgery could be of particular benefit to rural patients by reducing travel challenges, costs, improving scheduling flexibility and reinforcing independence. The hypothesis is that routine telehealth follow-up for elective surgical procedures, of all complexity, will provide equivalent outcomes and improved patient satisfaction and access in comparison to face-to-face follow-up. Significance: VA Integrated Service Network (VISN) 19 is the largest geographic region in the VA system and includes four intermediate/complex VA Medical Centers (VAMC) serving rural and urban patients across 10 states. Almost 4000 unique patients are seen annually at these 4 centers resulting in 2600 operations and over 16,000 patient encounters. Another 2500 unique patients are referred to community care (CC) at a cost of over $5 million in FY23. Improving access through telehealth in this largely rural VISN will positively impact Veterans and reduce community care expenditures in addition to improving patient and provider satisfaction. Innovation & Impact: There are currently no funded or published randomized trials evaluating the efficacy of telehealth in providing postoperative surgical care to rural patients. The proposal will provide robust, Level 1 data confirming the safety of postoperative telehealth care. In addition, the investigators will provide the only evaluation of both the patient and provider experience in rural, surgical telehealth care. They will leverage the largest geographic region, VISN19, to ensure broad applicability of findings to rural and urban Veterans. Specific Aims: Aim 1: Evaluate the safety of postoperative telehealth in rural and urban Veterans. Aim 2: Evaluate the usability and patient satisfaction of telehealth in comparison to in-person postoperative follow-up. Aim 3: Evaluate the usability and provider satisfaction of telehealth in comparison to in-person follow-up. Methodology: Patients undergoing elective general surgical procedures (both inpatient and outpatient) at four VA medical centers (Denver, CO; Oklahoma City, OK; Muskogee, OK; Salt Lake City, UT) in VISN 19 will be randomized to post-operative follow-up in person or via telehealth. Patients who discharge with drains or wound vacuum therapy, permanent suture or staples will be excluded. Aim 1: 30-day morbidity, missed adverse events (complications that may have been recognized with in-person follow-up), 30-day mortality, 30-day readmission, and 30-day ED visits will be compared evaluated to determine safety of telehealth follow-up. Aim 2: Post-operative surveys at 6 weeks after surgery will quantify acceptability of telehealth follow-up via the standardized Telehealth Usability Questionnaire; satisfaction and usability will be compared via the Consumer Assessment of Healthcare Providers and Systems Outpatient and Ambulatory Surgery survey (S-CAHPS) between the groups. Patients will also be characterized by baseline demographics, distance to nearest facility, socioeconomic vulnerability and procedure type to further define optimal cohorts for future telehealth participation and implementation. Aim 3: Usability and satisfaction for Providers will be determined by self-developed survey. Bi-monthly responses will be recorded to define trends and optimize future implementation. Next Steps/Implementation: If safe and acceptable to patients and providers, standardization for telehealth follow-up after surgery can be implemented nation-wide to improve access to care and satisfaction.

NCT ID: NCT06201884 Not yet recruiting - Surgery Clinical Trials

Efficacy of Adapted Physical Activity on a Walking Platform in Elderly Patients HOspitalized for Cancer Surgery

APPAHOCA-2
Start date: February 2024
Phase: Phase 2
Study type: Interventional

The aim of this study was to evaluate the efficacy of daily use of a walking platform to improve recovery of preoperative walking speed at hospital discharge following oncological surgery in patients aged 65 or older.

NCT ID: NCT06184724 Not yet recruiting - Surgery Clinical Trials

Implementation Pilot of Preoperative CGA Before Major Surgery

Start date: April 2026
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to test whether a new implementation package can help older adults prepare for major surgery. The main question it aims to answer is: Can the implementation package help give more people access to this resource? Participants will be in two groups: older adults who are planning a major surgery and their medical and surgical healthcare providers. The results will be compared to a historic baseline.

NCT ID: NCT06174701 Not yet recruiting - Surgery Clinical Trials

PST in Surgery: Feasibility and Acceptability Pilot

Start date: February 1, 2024
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to test problem solving therapy (PST) in older adults who are undergoing major surgery. The main question it aims to answer is: • What is the feasibility and acceptability of delivering PST to older surgical patients with depressive symptoms or report lacking social support in the pre-operative and post-operative setting?

NCT ID: NCT06161207 Not yet recruiting - Surgery Clinical Trials

3D-4K-ICG Laparoscopic Gastrectomy for Gastric Cancer

3D-4K-ICG
Start date: January 1, 2024
Phase: Phase 3
Study type: Interventional

Patients with locally advanced gastric adenocarcinoma (CT2-4a N-/+ M0) were selected as study subjects to investigate the safety, efficacy, and feasibility of ICG near-infrared imaging tracing in 3D plus ultra high resolution laparoscopic gastrectomy with lymph node dissection for gastric cancer.

NCT ID: NCT06154460 Not yet recruiting - Surgery Clinical Trials

The Effects of Different Surgical Stabilization Methods in Recurrent Anterior Shoulder Instability

SSM-SI
Start date: December 18, 2023
Phase:
Study type: Observational

Shoulder instability is the inability to retain the humeral head in the glenoid fossa. The incidence of instability is 8.2 to 23.9 per 100,000 person-years with an estimated prevalence of 1.7%. The most common shoulder instability with a rate of 98% is anterior dislocation, in which the humeral head is displaced anterior to the glenoid. Conservative and surgical treatments of instability are available. There are many controversial issues related to these methods in the literature. For example; an atrophy and functional loss in the infraspinatus after reimplissage, atrophy and loss of proprioception in the muscles around the shoulder after capsular repair, and loss of proprioception after the laterjet procedure have been reported.Therefore, the aim of this study was to compare different surgical stabilization methods in terms of pain, proprioceptive sensation, functional status and muscle activation in recurrent anterior shoulder instability, which is very common in adults.