Parkinson's Trial NCT03945968
Improve postoperative complication risk stratification
- Trial ID
- NCT03945968
- Official Title
- The Role of Concomitant Diseases in Postoperative Complications Risk Stratification - a Prospective Observational Multi-center Cohort Study
- Goal
- Improve postoperative complication risk stratification
- Status
- RECRUITING
- Sponsor
- Russian Federation of Anesthesiologists and Reanimatologists
- Study Type
- OBSERVATIONAL
- Enrollment
- 16000 participants
- Conditions
- Coronary Heart Disease, Anemia, Bronchial Asthma, Stroke, Epilepsy, Parkinson's Disease, Heart Rhythm Disorders, Alzheimer's Disease, Neuromuscular Diseases, Diabetes, Chronic Heart Failure, Chronic Obstructive Pulmonary Disease, Chronic Kidney Diseases
Summary For Families
Trying to pin down how other long-term illnesses, including Parkinson's, change the chance of problems after abdominal surgery so doctors can better predict and plan care. Researchers are following about 16,000 adults across multiple hospitals who are having abdominal operations, recording their existing diseases, ASA anesthesia risk class, and any postoperative complications; it is a prospective observational study, so no new drugs or devices are given, just systematic data collection to improve risk models. Adults 18 and older undergoing abdominal surgery with ASA class 1 to 3 can join, while people who cannot have the needed factors assessed or who have acute events like massive bleeding, aspiration, severe bronchospasm, anaphylaxis, or malignant hyperthermia are excluded.
Locations
- The First City Clinical Hospital. n.a. E. E. Volosevich, Arkhangelsk, Russia
- Astrakhan State Medical University, Astrakhan, Russia
- Chelyabinsk Regional Clinical Center of Oncology and Nuclear Medicine, Chelyabinsk, Russia
- South-Ural State Medical University, Chelyabinsk, Russia
- Chita state medical Academy of the Ministry of health of the Russian Federation, Chita, Russia
- Kazan State Medical University, Kazan', Russia
- Republic Clinical Hospital Ministry of Health care of the Republic of Tatarstan, Kazan', Russia
- Research Institute for Complex Issues of Cardiovascular Diseases, Kemerovo, Russia
- Regional clinical hospital №2, Krasnodar, Russia
- Kuban State Medical University, Krasnodar, Russia
- Research Institute Regional Clinical Hospital named after S.V. Ochapovsky, Krasnodar, Russia
- Krasnoyarsk State Medical University named after Prof. V.F.Voino-Yasenetsky, Krasnoyarsk, Russia
- Burnasyan federal medical biophysical center of federal medical biological agency, Moscow, Russia
- City clinical hospital named after S.S. Yudin, Moscow, Russia
- City clinical hospital №1 named after N.I. Pirogov, Moscow, Russia
- City Clinical Hospital. n.a. F.I. Inozemtseva, Moscow, Russia
- FGBU "Central clinical hospital with polyclinic" of the President administration of the Russian Federation, Moscow, Russia
- Moscow cancer research Institute named after P. A. Herzen, Moscow, Russia
- Moscow City Oncological Hospital № 62, Moscow, Russia
- Moscow regional research clinical Institute named after M. F. Vladimirsky, Moscow, Russia
And 18 more locations.
Frequently Asked Questions
- What is this trial testing?
- This trial is studying an experimental treatment. Trying to pin down how other long-term illnesses, including Parkinson's, change the chance of problems after abdominal surgery so doctors can better predict and plan care. Researchers are following about 16,000 adults across multiple hospitals who are having abdominal operations, recording their existing diseases, ASA anesthesia risk class, and any postoperative complications; it is a prospective observational study, so no new drugs or devices are given, just systematic data collection to improve risk models. Adults 18 and older undergoing abdominal surgery with ASA class 1 to 3 can join, while people who cannot have the needed factors assessed or who have acute events like massive bleeding, aspiration, severe bronchospasm, anaphylaxis, or malignant hyperthermia are excluded.
- Who can participate?
- Participants must be at least 18 Years.
- Where is this trial located?
- This trial is recruiting at 38 locations.
- Does it cost anything to join?
- You are never charged a fee to join a legitimate clinical trial, and the study treatment and study-specific tests are provided by the trial sponsor at no charge. In the US, routine care you would receive anyway can still be billed to you or your insurance; coverage rules differ by country, and trials in the UK and Canada usually run through public health systems. Travel, parking, and time are real costs, and some trials reimburse them while others do not. Before enrolling, ask the study coordinator to explain in writing what is and is not covered.
- How long does the trial last?
- This trial is estimated to last approximately 6 years and 6 months.
- Can I leave the trial if I change my mind?
- Yes. You can withdraw from any clinical trial at any time, for any reason, without affecting your standard medical care. Trials are voluntary by law. The team may ask if you are willing to do a brief exit visit so they can collect safety information, but you are not obligated.
- Can my spouse or care partner come with me to visits?
- In most cases yes, and it is often encouraged. Care partners can help with notes, questions, and getting home safely after a long visit. Some study assessments do need to happen one on one, but care partners are usually welcome for the rest of the appointment.
- Will I get a placebo in this trial?
- This is an observational study, so there is no placebo and no experimental treatment is assigned. Researchers observe and collect information while you continue your usual care.
- What procedures are involved in this trial?
- Based on the protocol, this trial involves: Surgical procedure (invasive); Intravenous infusion (minimally invasive); Questionnaires & surveys (non-invasive). Confirm the full schedule with the study coordinator.