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Surgery clinical trials

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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: NCT06120426 Recruiting - Surgery Clinical Trials

En Bloc Resection Versus Separation Surgery Combined With Radiotherapy for the Treatment of Spinal Oligometastatic Tumor.

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

The purpose of this clinical trial is to explore the impact of En bloc surgery and separation surgery combined with radiation therapy on the prognosis and survival of patients with spinal oligometastatic cancer, describe the clinical results, and optimize future treatment goals

NCT ID: NCT06120114 Completed - Surgery Clinical Trials

Laparoscopic High-Ligation Repair of Indirect Inguinal Hernias in Adults

Start date: June 20, 2015
Phase: N/A
Study type: Interventional

Inguinal hernia surgery has undergone significant and extensive transformation, including the advent of tissue-based repairs and later, tension-free repairs with the acceptance of prosthetic mesh. However, there is still significant pain associated with the use of mesh, as well as the risk of potential injury to neurovascular structures. In the pediatric population, non-mesh laparoscopic high-ligation repair of indirect inguinal hernias is one of the most common procedures performed. High-ligation of indirect inguinal hernias in the adolescent population is also effective, with a low recurrence rate and low incidence of chronic symptoms, but this technique is uncommonly used by adult hernia surgeons due to concern for recurrence.The purpose of this study is to conduct a pilot trial to examine the efficacy of high-ligation repair of indirect inguinal hernias in adult patients. Our hypothesis is that the laparoscopic, non-mesh repair technique is an effective method of repairing indirect inguinal hernias, with an acceptable recurrence rate and decreased postoperative pain. This pilot trial will allow the design of a randomized clinical trial comparing the efficacy of this technique to other standard repair techniques.

NCT ID: NCT06115759 Recruiting - Clinical trials for Cardiovascular Diseases

RCT on T-REX Twente Regimen Effects on Quality of Life and Mobilisation for Cardiac Surgery Patients After Sternotomy

T-REX Twente
Start date: May 21, 2024
Phase: N/A
Study type: Interventional

The goal of this study is whether the T-REX Twente precautions have a positive impact on the quality of life (MAcNew QLMI), level of physical activity, and reduction of fear of movement in heart patients after a total median sternotomy compared to the (current) standard precautions? Do these precautions also have no adverse effects on pain, wound healing, and/or postoperative complications? Participants will be instructed by the physiotherapist to both groups immediately postoperatively and are constantly repeated by the involved disciplines during the hospital stay. The control group is not allowed to lift, push, or pull for the first 6 weeks. There is little to no evidence for the current strict precautions currently implemented in the department. The intervention group receives the new T-REX Twente precautions, allowing for more independent activities through the use of the tube model (keeping elbows close to the sides). All patients receive three questionnaires (MacNew QLMI, Numeric Pain Rating Scale, and Tampa Scale for Kinesiophobia) preoperatively, on the 4th day postoperatively, on the first day of cardiac rehabilitation, and at the end of cardiac rehabilitation, taking approximately 10 minutes each time. Additionally, during the clinical admission immediately postoperatively, two AX3 accelerometers are placed on the patient, one lateroproximal on the right upper arm and one anterodistal on the right upper leg. Researchers will compare heart patients after a total median sternotomy with T-REX Twente precautions (intervention group) to the (current) standard precautions (control group).

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: NCT06103136 Recruiting - Surgery Clinical Trials

Maestro 1.0 Post-Market Registry

Start date: September 29, 2023
Phase:
Study type: Observational [Patient Registry]

The objective of the study is to observe the real-life usage of the Maestro Platform for surgical assistance in laparoscopic surgery.

NCT ID: NCT06101732 Completed - Breast Cancer Clinical Trials

LIMBO : Breast Reconstruction by Lipomodeling Alone or With Flap: Evaluation in Franche-Comté

LIMBO
Start date: May 5, 2022
Phase:
Study type: Observational

The Limbo study is a retrospective descriptive study which aims to establish the current state of breast reconstruction surgery at the Besançon University Hospital and Hôpital Nord Franche-Comté, between October 2017 and December 2021.

NCT ID: NCT06101511 Recruiting - Surgery Clinical Trials

Driving Pressure During General Anesthesia for Minimally Invasive Abdominal Surgery (GENERATOR)

GENERATOR
Start date: December 11, 2023
Phase: N/A
Study type: Interventional

The purpose of this international multicenter, patient and outcome-assessor blinded randomized controlled trial is to determine whether the application of an individualized high Positive End Expiratory Pressure (PEEP) strategy with recruitment maneuvers, aiming at avoiding an increase in the driving pressure during intraoperative ventilation, protects against the development of postoperative pulmonary complications in patients undergoing minimally invasive abdominal surgery.

NCT ID: NCT06095661 Completed - Surgery Clinical Trials

Virtual Reality as a Postoperative Pain Management Adjunct in Older Adults: An Acceptability and Feasibility Study

VR
Start date: October 26, 2023
Phase: N/A
Study type: Interventional

This single-arm mixed methods study aims to determine potential differences in self-reported postoperative pain intensity levels, anxiety, and state of relaxation through immediate pre-post intervention evaluation among those aged 65 or older who receive immersive virtual reality during their hospitalization, up to three days following major elective surgery. In addition, the investigators will evaluate the feasibility and acceptability of virtual reality for use in this older adult population. This study will not evaluate the efficacy of VR. The main questions this study seeks to answer are: 1. What is the feasibility and acceptability of using immersive virtual reality to impact clinical outcomes such as pain, anxiety, and relaxation in older adults who have undergone major elective surgery? 2. What is the older adult's user experience with virtual reality during hospitalization up to the three days following major elective surgery?

NCT ID: NCT06095362 Enrolling by invitation - Surgery Clinical Trials

Thyroid Cancer and Central Lymph Node Metastases Detection Using Bevacizumab-IRDye800CW

TARGET-beva
Start date: November 29, 2021
Phase: Phase 1
Study type: Interventional

Background: Papillary thyroid cancer (PTC) patients often develop central lymph node metastases (CLNM), which pose a high risk of disease recurrence. The prophylactic central lymph node dissection (PCLND) is controversial, with proponents arguing for it to prevent local recurrence, and opponents objecting to the hypoparathyroidism and nerve damage risk. Currently, no diagnostic tool exists to identify patients who would benefit from a PCLND. Molecular Fluorescence Guided Surgery (MFGS) is a potential solution that uses fluorescent tracers to detect cancerous tissue. This study aims to investigate whether the administration of a GMP-produced near infrared (NIR) tracer, bevacizumab-IRDye800CW, targeting VEGF-A, can enable intraoperative selection of PTC/FTC/HTC patients for CLND. Objective: The primary objective of the study is to determine the optimal dose of bevacizumab-IRDye800CW for an adequate tumor-to-background ratio (TBR) in PTC/FTC/HTC lymph node metastases. The secondary objectives are to evaluate the feasibility of MFGS for PTC/FTC/HTC and nodal metastasis assessment, to correlate and validate fluorescence signals detected in vivo with ex vivo histopathology and immunohistochemistry, to evaluate the distribution of bevacizumab-IRDye800CW on a microscopic level, and to quantify the sensitivity and specificity of bevacizumab-IRDye800CW for PTC/FTC/HTC and nodal metastasis. Study Design: The TARGET-BEVA study is a non-randomized, non-blinded, prospective, single-center phase I feasibility study for patients with confirmed PTC/FTC/HTC, for which the best TBR dosage group in PTC/FTC/HTC nodal metastasis will be determined. The study will initiate with a 3 x 3 scheme: 4,5 mg, 10 mg, and 25 mg, with three patients confirmed with lymph node metastasis in each group. Dosages will be based on previous studies, with the primary objective being the detection of lymph node metastasis. After the first 9 patients, an interim analysis will be performed, after which the best dosage group will be expanded with another 7 patients. Conclusion: The study aims to identify a novel diagnostic tool that can aid clinicians in selecting patients for PCLND, enabling a reduction in overtreatment, morbidity, and costs while maintaining effectiveness with a lower recurrence rate and improved quality of life.