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?
- No. There is no cost to participate. Study-related care and treatment are provided at no charge.
- How long does the trial last?
- This trial is estimated to last approximately 6 years and 6 months.
- Will I get the real drug or a placebo?
- It depends on the trial design. Some Parkinson's trials are placebo controlled, meaning a portion of participants get an inactive comparison while others get the experimental treatment. Some use crossover designs so everyone eventually receives the active treatment at some point. Observational trials do not use a placebo at all because they are not testing a new treatment. The consent form for any specific trial spells out the design and your odds of being assigned to placebo before you enroll.
- How often will I need to visit the study site?
- Visit frequency varies by trial. Many Parkinson's studies require an in person visit every 4 to 12 weeks during the active treatment phase, with shorter or longer gaps depending on the design. The site coordinator can give you the full visit schedule before you sign anything, so you know what the time commitment looks like.
- 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.
- Will travel or parking be reimbursed?
- Many trials reimburse for parking, mileage, and sometimes lodging if the site is far from your home. Reimbursement policies vary by sponsor and site. When you contact the trial team, ask specifically what is covered and how reimbursement is processed.
- 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.