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Surgery clinical trials

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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 - Gastric Cancer 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.

NCT ID: NCT06146270 Not yet recruiting - Surgery Clinical Trials

Russian Registry of Surgical OutcomeS

RuSOS
Start date: March 1, 2024
Phase:
Study type: Observational

Identification of risk factors that cause a high probability of an unfavorable outcome in the postoperative period is an urgent problem. The creation of national databases (registries) makes it possible to maximally cover a certain patient population by identifying its characteristic risk predictors. As literature data show, existing registries differ in the criteria for inclusion in the study, in the characteristics of the populations studied, and there is often no common view on the classification of postoperative outcomes. Goal of a study is a creation of a Russian national calculator for the risk of postoperative complications and mortality. Two-level observational retrospective-prospective study was planned. Setting: National multicenter study of surgical inpatients. Patients: Adult patients undergoing elective and emergency surgery. Types of interventions: in obstetrics, in gynecology, on the breast, in urology and kidneys, in endocrine surgery, in maxillofacial surgery, in orthopedics and traumatology, on the lower floor of the abdominal cavity, on the liver and biliary tract, on the upper floor of the abdominal cavity cavities, in thoracic surgery, in vascular surgery, in neurosurgery, in cardiac surgery, in other areas (with mandatory specification). The study was organized by the Federation of Anesthesiologists and Reanimatologists of Russia. Primary (30-day mortality, 30-day complications) and secondary (hospital mortality, hospital complications, length of stay in anesthesiology, resuscitation and intensive care departments, length of hospital stay, multiple organ failure (2 or more points on the SOFA scale (Sequential)) Organ Failure Assessment), 90-day mortality, 90-day complications, intensive care after-effects syndrome, readmission, 1-year mortality) outcomes were determined. The required sample size and statistical analysis methods are described. The planned duration of the study is 2024-2028.

NCT ID: NCT06145516 Not yet recruiting - Surgery Clinical Trials

Promoting Sleep to Alleviate Pain - Arthroplasty

PROSAP-A
Start date: January 2024
Phase: N/A
Study type: Interventional

PROSAP-A is a perioperative randomized, controlled trial with a 12-month follow-up period after total knee arthroplasty (TKA) or total hip arthroplasty (THA), aiming to investigate both acute and long-term postoperative effects of preoperative sleep-promotion. Participants with clinically significant insomnia symptoms will be randomized to a brief, hybrid version of cognitive behavioral therapy for insomnia (CBT-I) or sleep education therapy, administered over a 4-week period, prior to surgery. The primary objectives are to evaluate effects of preoperative sleep-promotion on acute and long-term postoperative pain control. Secondary objectives include evaluation of postoperative sleep, recovery, mental health, cognitive function and alterations in blood biomarkers.

NCT ID: NCT06142604 Not yet recruiting - Atrial Fibrillation Clinical Trials

Single Dose Flecainide for Early Sinus Rhythm Conversion of Perioperative Atrial Fibrillation After Noncardiac Surgery

FLIP-AF
Start date: July 1, 2024
Phase: Phase 4
Study type: Interventional

Investigator-initiated pilot study of single dose oral flecainide versus no flecainide for the early conversion of perioperative atrial fibrillation to sinus rhythm after noncardiac surgery.

NCT ID: NCT06133413 Not yet recruiting - Surgery Clinical Trials

Connected Scales to Optimize the Maintenance of Weight Lost After Bariatric Surgery and Limit Failures and Reoperations

COMPA
Start date: May 2024
Phase: N/A
Study type: Interventional

In this research, we hypothesize that post-operative monitoring implemented with a connected scale after the 1st year (weight nadir period) post obesity surgery (i.e. sleeve and RYGB) would reduce the percentage of patients with excessive weight regain (>10% regain of lost weight) by improving the quality of follow-up and long-term results. To do this, we are carrying out a comparative study on 182 patients, controlled, randomized per patient, ratio 1/1, open, in two parallel arms. Patients will be followed for 12 months and divided into one of the following two groups: - Control group: Standard follow-up - Interventional group: Standard follow-up + weekly weighing with the "Body Comp Pro" connected scale During their follow-up period, patients in the intervention group will have to weigh themselves at least once a week using the "Body Comp Pro" connected scale. The information will be transmitted to the investigation team via a secure platform available 24 hours a day. Alerts will be generated from a weight regain > 5% of the baseline weight, allowing early management of weight regain.

NCT ID: NCT06127758 Not yet recruiting - Surgery Clinical Trials

Effect of Virtual Reality Glasses Application on Surgical Fear and Anxiety

Start date: November 2023
Phase: N/A
Study type: Interventional

Purpose and Type of Research:This study will be conducted to examine the effect of virtual reality glasses on surgical fear and anxiety in patients scheduled for cardiovascular surgery. The study is a randomized controlled experimental research. Method:The population of the research was approximately 2900 patients who underwent cardiovascular surgery in a year at Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Education Research Hospital. The sample size of the study was calculated using the G*Power software program.The study will be completed with 60 people by taking 30 people into the experimental and control groups.Data will be collected with a personal information form, surgical fear scale and state anxiety scale. Hypothesis of the Research: H1: Application of virtual reality glasses reduces surgical fear in patients planned for cardiovascular surgery. H2: Application of virtual reality glasses reduces anxiety in patients scheduled for cardiovascular surgery.

NCT ID: NCT06113614 Not yet recruiting - Surgery Clinical Trials

Effects of Photobiomodulation on Functional Recovery of Proximal Humerus Fractures

Start date: April 30, 2024
Phase: N/A
Study type: Interventional

This double-blind, randomized controlled clinical study aims to evaluate the effects of PBM on the functional recovery of participants with surgically treated PHF using special locking plates. The 42 participants will be randomized (1:1) into two groups: the Control group (standard physical therapy combined with simulated PBM) and the PBM group (standard physical therapy combined with active PBM). Participants will apply PBM at home daily for 10 minutes using a device containing 318 light-emitting diodes (LEDs), with 159 LEDs at 660 nm (28.5 mW; 12 J/cm2; 17 J per LED) and 159 LEDs at 850 nm (23 mW; 10 J/cm2; 14 J per LED). PBM and physical therapy sessions (30 minutes, twice a week) will be conducted over 12 weeks. Participants will be unaware of their group allocation and will be assessed at 24 hours, 1, 2, 4, 8, and 12 weeks after surgery by four examiners who are also blinded to each participant's allocation. The primary outcome, assessed at all time points, will be shoulder function recovery using the Quick-DASH functional scale. Secondary outcomes will include shoulder range of motion assessments with a digital goniometer, quality of life using the SF-6 questionnaire, and the occurrence of adverse effects at all time points. Spontaneous pain, pressure pain (measured with a dolorimeter), nighttime pain, and analgesic use will be evaluated at 1, 2, 4, 8, and 12 weeks. Fracture consolidation will be assessed at 4, 8, and 12 weeks through radiographic examinations, and muscle strength will be evaluated by progressive dumbbell support at 8 and 12 weeks. In addition to the scheduled assessments, participants will be contacted daily by phone.

NCT ID: NCT06080997 Not yet recruiting - Pain Clinical Trials

Patients' Expectations Before Spinal Surgery

Start date: December 1, 2023
Phase:
Study type: Observational

With this study the investigators want to perform a prospective observational cohort study at Zealand University Hospital, Koege, Denmark. The purpose of this study is twofold: 1. to investigate how expectations predict patients' pain, rehabilitation and quality of life after spinal surgery. 2. to explore the patients' expectations before, and their experiences after, spinal surgery regarding pain, rehabilitation and quality of life.