Clinical trials: Surgery-first
Minimally Invasive Surgery Basic Skills
Goal-directed MIS Simulation Training With the LTB-Curriculum Prior to First Operations on Patients: Study Protocol for a Multi-centre Randomized Controlled Validation Trial (NOVICE)
Background: Laparoscopic surgical procedures have become increasingly established in operative medicine. They require special motor, haptic, and spatial-visual skills to perform the interventions safely and effectively.
- Trial name
- NOVICE (NCT03040544)
- Testing
- LTB-Curriculum, Laparoscopic cholecystectomy
- Where
- Germany
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- University Hospital Schleswig-Holstein
Anxiety, Pain
Effectiveness of Virtual Reality in Reducing Anxiety and Pain During the First Postoperative Orthopedic Dressing Change in Pediatric Patients
The goal of this randomized clinical trial is to learn whether immersive virtual reality can reduce anxiety and pain in children and adolescents undergoing postoperative orthopedic dressing changes.
- Conditions
- Anxiety, Pain, Post Operative
- Trial name
- VR OrthoPed (NCT07729020)
- Testing
- Immersive Virtual Reality Distraction, Standard Postoperative Dressing Care
- Where
- Italy
- Volunteers
- 48 people
- Sponsor
- Gianluca Catania
Neuroblastoma
An Imaging Study of Anti-GD2-800CW in Patients With Neuroblastoma
This is a non-randomized, open label phase Ib/II dose-escalation and expansion study designed to define the recommended dose of anti-GD2-800CW in pediatric neuroblastoma patients.
- Trial name
- GLOW-FISH (NCT07399821)
- Testing
- anti-GD2-800CW
- Where
- Netherlands
- Volunteers
- 22 people
- Sponsor
- Princess Maxima Center for Pediatric Oncology
Thyroid Gland Disease, Surgery
TOETVA Feasibility and Complications - Single Center First Experience
All participants who underwent (or will undergo) a transoral endoscopic thyroidectomy via vestibular approach (TOETVA) at the investigators' center are observed for complications and feasibility of this surgery.
- Trial name
- NCT05396703
- Testing
- TOETVA
- Where
- Netherlands
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Zuyderland Medisch Centrum
Hydrocephalus
First-in-human Trial of Home Brain Pressure Measured Using Kitea ICP Sensor, Placed During Hydrocephalus Shunt Surgery.
Patients with hydrocephalus have an abnormal build-up of fluid around the brain and need a tube surgically implanted to drain that fluid. Patients and their caregivers live with the constant fear that the tube will block.
- Trial name
- HomeICP (NCT06402786)
- Testing
- Kitea ICP Sensor
- Where
- New Zealand
- Volunteers
- 21 people
- Sponsor
- University of Auckland, New Zealand
Surgically Repaired Unilateral Cleft Lip and Palate
Evaluation of Arch Dimensions of Children With Surgically Repaired Unilateral Cleft Lip and Palate
The aim of the study is to assess arch dimensions among children with surgically repaired unilateral cleft lip and palate.
- Trial name
- NCT03219021
- Volunteers
- 233 people, healthy volunteers welcome
- Sponsor
- Menna Allah Mohammed Awad
Breast Cancer
Biomarker (p53 Gene) Analysis and Combination Chemotherapy Followed by Radiation Therapy and Surgery in Treating Women With Large Operable or Locally Advanced or Inflammatory Breast Cancer
RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Currently patients with breast cancer are treated with one of several very similar combinations of drugs.
- Trial name
- NCT00017095
- Testing
- filgrastim, cyclophosphamide, docetaxel
- Where
- 39 sites in Belgium, France and 7 more
- Volunteers
- 1,856 people
- Sponsor
- European Organisation for Research and Treatment of Cancer - EORTC
Microtia
Long-Term Follow-Up Study of Unilateral Microtia Patients Implanted With AUR-201
Long-term follow-up of unilateral microtia patients implanted with AUR-201.
- Trial name
- AUR-201 (NCT06078566)
- Testing
- AUR-201
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Auregen Biotherapeutics, SA
Congenital Pulmonary Airway Malformation
The COllaborative Neonatal Network for the First CPAM Trial
The goal of this clinical trial is to compare conservative wait-and-see management to elective surgical intervention, in asymptomatic Congenital Pulmonary Airway Malformation (CPAM) children.
- Trial name
- CONNECT (NCT05701514)
- Testing
- Elective surgical resection of CPAM between 6 and 9 months of age
- Where
- 2 sites in Netherlands
- Volunteers
- 176 people
- Sponsor
- Erasmus Medical Center
Infant, Newborn, Infant, Low Birth Weight
Laparotomy vs. Drainage for Infants With Necrotizing Enterocolitis
This study will compare the effectiveness of two surgical procedures -laparotomy versus drainage - commonly used to treat necrotizing enterocolitis (NEC) or isolated intestinal perforations (IP) in extremely low birth weight…
- Conditions
- Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature
- Trial name
- NEST (NCT01029353)
- Testing
- Laparotomy, Drainage
- Where
- 22 sites in United States
- Volunteers
- 529 people
- Sponsor
- NICHD Neonatal Research Network
Hepatocellular Carcinoma
Laparoscopic Surgery Versus Radiofrequency Ablation for Recurrent HCC
Hepatocellular carcinoma (HCC) is the fifth most common and the third leading cause of death from cancer worldwide1 . Hepatectomy is still the main effective treatment for HCC accompanying with well-preserved cirrhosis when liver…
- Trial name
- NCT02535117
- Testing
- Laparoscopic Surgery(LS), RFA
- Volunteers
- 216 people
- Sponsor
- Sun Yat-sen University
Surgery
Immersive Care - Virtual Reality(VR) 360 Pediatric Surgery Preparation.
Context: This study is part of the larger Immersive Care project which (in short) seeks the connection between technology and care by conducting feasibility studies with promising technological interventions tailored to care.
- Trial name
- NCT04658030
- Testing
- VR 360 video surgery preparation, Care as usual
- Where
- Belgium
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Thomas More University of Applied Sciences
Patient Safety, Resident Work Hours
Flexibility In Duty Hour Requirements for Surgical Trainees Trial - "the FIRST Trial"
Resident duty hour requirements in the U.S. are still evolving as stakeholders continue to debate how best to (re)structure postgraduate medical education.
- Trial name
- FIRST (NCT02050789)
- Testing
- flexible duty hours
- Volunteers
- 152 people
- Sponsor
- Northwestern University
Shoulder Dislocation, Sport Injury
RCT Evaluating First Time Shoulder Dislocation
The primary objective of the pilot study is to assess the feasibility of a definitive trial to determine the effect of arthroscopic soft tissue stabilization vs.
- Conditions
- Shoulder Dislocation, Sport Injury, Anterior Dislocation
- Trial name
- REDUCE (NCT05715021)
- Testing
- Bankart + Remplissage Procedure
- Where
- Canada
- Volunteers
- 100 people
- Sponsor
- McMaster University
Anterior Cruciate Ligament Rupture
Initial Graft Tension and ACL Surgery
The anterior cruciate ligament (ACL) is one of four strong ligaments connecting the bones of the knee joint. If overstretched, the ACL can tear. Reconstruction of a torn ACL is now a common surgical procedure.
- Trial name
- NCT00434837
- Testing
- Initial graft tension during ACL reconstruction surgery
- Where
- 2 sites in United States
- Volunteers
- 168 people, healthy volunteers welcome
- Sponsor
- Rhode Island Hospital
Osteosarcoma Metastatic, Pulmonary Disease
Osteosarcoma With Resectable Pulmonary Metastasis: A Retrospective Study
According to EURAMOS-1, 17% of osteosarcoma patients were considered to have metastases at diagnosis. In this selected cohort, the reported 5-year EFS from diagnosis of 28% compares well to previous results reported from…
- Conditions
- Osteosarcoma Metastatic, Pulmonary Disease, Resectable Sarcoma, Survival
- Trial name
- NCT04546243
- Testing
- resection group, radiotherapy group
- Where
- 2 sites in China
- Volunteers
- 127 people
- Sponsor
- Peking University People's Hospital
Congenital Heart Disease
Assessment of the Efficacy of the First Aspirin Dose in Children Undergoing Surgery for Congenital Heart Disease (CHD) Who Require Post-operative Antiplatelet Therapy
The use of heparin and aspirin for their respective anticoagulation and antiplatelet effects is routine in intensive care units around the country and world in children who have undergone surgery for congenital heart disease…
- Trial name
- NCT02064179
- Volunteers
- 75 people
- Sponsor
- University of Colorado, Denver
Pancreatic Cancer
Gemcitabine With or Without Combination Chemotherapy and Radiation Therapy in Treating Patients With Nonmetastatic Pancreatic Cancer That Cannot Be Removed By Surgery
RATIONALE: Drugs used in chemotherapy, such as gemcitabine, fluorouracil, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
- Trial name
- NCT00416507
- Testing
- fluorouracil, gemcitabine hydrochloride, liposomal cisplatin
- Volunteers
- 190 people
- Sponsor
- Federation Francophone de Cancerologie Digestive
Cleft Palate
Relational Development in Children With Cleft Lips and Palates: Influence of the Waiting Period Prior to the First Surgical Intervention and the Parents' Psychological Perception of the Abnormality
The treatment of patients suffering from cleft lip(s) with or without a cleft palate (CL/P) is multidisciplinary. The careful consideration of concerned families during the repetitive appointments required by these treatments…
- Trial name
- NCT00993993
- Where
- 6 sites in France
- Volunteers
- 150 people
- Sponsor
- University Hospital, Strasbourg, France
Skeletal Class III Malocclusion
Surgery-First Orthognathic Surgery in Skeletal Class III Treatment
This study evaluates the efficacy and stability of the "Surgery-First" approach (SF approach) in treating patients with skeletal Class III malocclusion, utilizing a combined retrospective and prospective data collection method.
- Trial name
- NCT07433842
- Testing
- Surgery-First Orthognathic Surgery
- Where
- Vietnam
- Volunteers
- 60 people
- Sponsor
- Hanoi Medical University