What is this study trying to find out about risks after abdominal surgery?

This study aims to understand how existing health conditions affect the chance of complications after abdominal surgery. Researchers want to identify which factors increase the risk to help improve patient care. The study is sponsored by the Russian Federation of Anesthesiologists and Reanimatologists.

Who may be eligible for this abdominal surgery clinical trial?

Adults aged 18 and older who are undergoing surgery on abdominal organs and have a physical status of ASA class 1 to 3 may be eligible. The study includes all genders and excludes patients unable to assess required health factors or those with certain acute conditions. Please review eligibility criteria for more details.

Is there any cost to participate in this abdominal surgery clinical trial?

Study-related care, including all procedures and trial visits, is provided at no cost. However, personal travel expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for any travel or accommodation costs.

Actively Recruiting

Age: 18Years +

All Genders

ID03945968

The Role of Concomitant Diseases in Postoperative Complications Risk Stratification - a Prospective Observational Multi-center Cohort Study

Led by Russian Federation of Anesthesiologists and Reanimatologists · Updated on 2025-04-04

16000

Participants Needed

Research Sites

8 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are investigating how other existing health conditions affect the risk of complications after abdominal surgery. This observational study aims to understand the frequency and types of additional diseases among surgical patients and identify key factors that predict postoperative problems. The goal is to help better assess and manage risks for patients undergoing planned abdominal operations. The study collects information about patients' age, gender, physical status by the ASA scale, presence of various diseases such as heart, lung, kidney, neurological, and metabolic conditions, and treatments they receive. It also records details about the type and severity of surgery, anesthesia methods, and uses various assessment scales related to cognition, respiratory and cardiovascular risk, liver and kidney function. Data is gathered before surgery and patients are monitored until hospital discharge. Participants provide informed consent and their data is entered into a secure database. Researchers evaluate factors influencing complications within 7 days after surgery, as well as mortality within 30 days. Statistical analysis includes regression models to identify independent risk predictors. The study involves multiple centers and follows patients throughout the hospital stay, aiming to improve understanding of postoperative risks and guide preventive strategies.

CONDITIONS

Brief Title

The Role of Concomitant Diseases in Postoperative Complications Risk Stratification.

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Surgical interventions on the abdominal organs
ASA physical status class 1, 2, or 3
Adults aged 18 years or older

You will not qualify if you...

Inability to assess the factors included in the study
Acute massive blood loss
Aspiration
Bronchospasm
Anaphylactic reactions
Malignant hyperthermia

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person) for informed consent and eligibility assessment

Diagnostic Evaluation

Duration - Day of surgery

Before surgery, participants' data and relevant health factors are collected and entered into the study database.

1 visit (in-person) on the day of surgery for data collection

Surgery and Immediate Post-operative Care

Duration - Up to discharge from hospital

Participants undergo planned abdominal surgery with monitoring of anesthesia and surgical factors.

Hospital stay visits until discharge (variable duration)

Post-operative Follow-up

Duration - 30 days after surgery

Participants are monitored for postoperative complications and mortality outcomes after surgery.

Follow-up assessments up to 30 days after surgery, including data collection before hospital discharge and monitoring for complications

Trial Site Locations

Total: 38 locations

The First City Clinical Hospital. n.a. E. E. Volosevich

Arkhangelsk, Russia

Actively Recruiting

Astrakhan State Medical University

Astrakhan, Russia

Actively Recruiting

Chelyabinsk Regional Clinical Center of Oncology and Nuclear Medicine

Chelyabinsk, Russia

Actively Recruiting

South-Ural State Medical University

Chelyabinsk, Russia

Actively Recruiting

Chita state medical Academy of the Ministry of health of the Russian Federation

Chita, Russia

Actively Recruiting

Kazan State Medical University

Kazan', Russia

Actively Recruiting

Republic Clinical Hospital Ministry of Health care of the Republic of Tatarstan

Kazan', Russia

Actively Recruiting

Research Institute for Complex Issues of Cardiovascular Diseases

Kemerovo, Russia, 650002

Actively Recruiting

Regional clinical hospital №2

Krasnodar, Russia, 350012

Actively Recruiting

Kuban State Medical University

Krasnodar, Russia, 350063

Actively Recruiting

Research Institute Regional Clinical Hospital named after S.V. Ochapovsky

Krasnodar, Russia

Actively Recruiting

Krasnoyarsk State Medical University named after Prof. V.F.Voino-Yasenetsky

Krasnoyarsk, Russia, 660022

Actively Recruiting

Burnasyan federal medical biophysical center of federal medical biological agency

Moscow, Russia, 123098

Actively Recruiting

City clinical hospital named after S.S. Yudin

Moscow, Russia

Actively Recruiting

City clinical hospital №1 named after N.I. Pirogov

Moscow, Russia

Actively Recruiting

City Clinical Hospital. n.a. F.I. Inozemtseva

Moscow, Russia

Actively Recruiting

FGBU "Central clinical hospital with polyclinic" of the President administration of the Russian Federation

Moscow, Russia

Actively Recruiting

Moscow cancer research Institute named after P. A. Herzen

Moscow, Russia

Actively Recruiting

Moscow City Oncological Hospital № 62

Moscow, Russia

Actively Recruiting

Moscow regional research clinical Institute named after M. F. Vladimirsky

Moscow, Russia

Actively Recruiting

National Medical and Surgical Center named after N.I. Pirogov

Moscow, Russia

Actively Recruiting

Privolzhsky district medical center

Nizhny Novgorod, Russia

Actively Recruiting

State Novosibirsk Regional Clinical Hospital

Novosibirsk, Russia

Actively Recruiting

Orenburg Regional Clinical Hospital

Orenburg, Russia

Actively Recruiting

"Republican hospital named after V. A. Baranov"

Petrozavodsk, Russia

Actively Recruiting

Rostov State Medical University

Rostov-on-Don, Russia

Actively Recruiting

North-West State Medical University named after I.I.Mechnikov

Saint Petersburg, Russia

Actively Recruiting

St. Petersburg state budgetary healthcare institution " City clinical Oncology dispensary"

Saint Petersburg, Russia

Actively Recruiting

"Samara Regional Clinical Oncology Dispensary"

Samara, Russia

Actively Recruiting

Clinical Hospital named after SR. Mirotvortseva (FGBOU VO "Saratov State Medical University. n.a. V.I.Razumovsky" Ministry of Health of the Russian Federation

Saratov, Russia

Actively Recruiting

Stavropol regional clinical hospital

Stavropol, Russia

Actively Recruiting

Regional Clinical Hospital No. 1

Tyumen, Russia

Not Yet Recruiting

Regional clinical hospital №2

Vladivostok, Russia

Actively Recruiting

Emergency hospital

Volgograd, Russia

Actively Recruiting

Volgograd regional clinical hospital

Volgograd, Russia

Actively Recruiting

Yakut Republican Oncological Dispensary

Yakutsk, Russia

Actively Recruiting

Ekaterinburg City clinical hospital № 40

Yekaterinburg, Russia

Actively Recruiting

Sverdlovsk regional clinicl hospital №1

Yekaterinburg, Russia

Actively Recruiting

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Research Team

Nikita Trembach, PhD

Igor Zabolotskikh, MD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

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Frequently Asked Questions

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Published Research Related To This Trial

Global patient outcomes after elective surgery: prospective cohort study in 27 low-, middle- and high-income countries.

https://pubmed.ncbi.nlm.nih.gov/28498884

Size and distribution of the global volume of surgery in 2012.

Thomas G Weiser, Alex B Haynes, George Molina...

https://pubmed.ncbi.nlm.nih.gov/26966331

The incidence and nature of surgical adverse events in Colorado and Utah in 1992.

A A Gawande, E J Thomas, M J Zinner...

https://pubmed.ncbi.nlm.nih.gov/10418594

Adverse events in surgical patients in Australia.

A K Kable, R W Gibberd, A D Spigelman

https://pubmed.ncbi.nlm.nih.gov/12201185

The Use of Regional or Local Anesthesia for Carotid Endarterectomies May Reduce Blood Loss and Pulmonary Complications.

Obaid S Malik, Ethan Y Brovman, Richard D Urman

https://pubmed.ncbi.nlm.nih.gov/30243870

Comparison of ECOG/WHO performance status and ASA score as a measure of functional status.

Jane Young, Tim Badgery-Parker, Timothy Dobbins...

https://pubmed.ncbi.nlm.nih.gov/24996034

An evaluation of the POSSUM surgical scoring system.

M S Whiteley, D R Prytherch, B Higgins...

https://pubmed.ncbi.nlm.nih.gov/8696749

Identifying older adults at risk of harm following elective surgery: a systematic review and meta-analysis.

Jennifer Watt, Andrea C Tricco, Catherine Talbot-Hamon...

https://pubmed.ncbi.nlm.nih.gov/29325567

Anesthetic management and one-year mortality after noncardiac surgery.

Terri G Monk, Vikas Saini, B Craig Weldon...

https://pubmed.ncbi.nlm.nih.gov/15616043

Mortality and readmission of patients with heart failure, atrial fibrillation, or coronary artery disease undergoing noncardiac surgery: an analysis of 38 047 patients.

Sean van Diepen, Jeffrey A Bakal, Finlay A McAlister...

https://pubmed.ncbi.nlm.nih.gov/21709059

The Role of Concomitant Diseases in Postoperative Complications Risk Stratification - a Prospective Observational Multi-center Cohort Study

On this page

Sponsors

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

AI-Screening

AI-Powered Screening

Your Study Journey

Trial Site Locations

Research Team

How is the study designed?

Similar Trials

129Xe Gas Exchange MRI to Visualize Cardiopulmonary Function

Vascular Function in Health and Disease: Rehabilitation for ...

To Investigate the Mechanism of Novel Molecular Probe [18F]A...

Frequently Asked Questions

What is this study trying to find out about risks after abdominal surgery?

Who may be eligible for this abdominal surgery clinical trial?

Is there any cost to participate in this abdominal surgery clinical trial?

What will I be asked to do in this abdominal surgery study?

How do researchers measure complications after surgery in this study?

What happens after this abdominal surgery clinical trial ends?

Can I leave this abdominal surgery clinical trial if I change my mind?

Not the Right Trial for You?

Published Research Related To This Trial

Global patient outcomes after elective surgery: prospective cohort study in 27 low-, middle- and high-income countries.

Size and distribution of the global volume of surgery in 2012.

The incidence and nature of surgical adverse events in Colorado and Utah in 1992.

Adverse events in surgical patients in Australia.

The Use of Regional or Local Anesthesia for Carotid Endarterectomies May Reduce Blood Loss and Pulmonary Complications.

Comparison of ECOG/WHO performance status and ASA score as a measure of functional status.

An evaluation of the POSSUM surgical scoring system.

Identifying older adults at risk of harm following elective surgery: a systematic review and meta-analysis.

Anesthetic management and one-year mortality after noncardiac surgery.

Mortality and readmission of patients with heart failure, atrial fibrillation, or coronary artery disease undergoing noncardiac surgery: an analysis of 38 047 patients.

On this page

Sponsors