Postoperative Pulmonary Complications in Major Abdominal Surgery (NCT01701908) | Clinical Trial Compass
CompletedNot Applicable
Postoperative Pulmonary Complications in Major Abdominal Surgery
Italy1,542 participantsStarted 2013-04-17
Plain-language summary
Incidence of Postoperative Pulmonary Complications (PPCs) varies from 2% to 19%, according to the population under examination and the criteria used to define pulmonary complications. There is no univocal definition of PPCs. Usually physicians associate atelectasis, respiratory insufficiency, pneumonia, bronchospasm, necessity to reintubate. Moreover the evaluation of risk factors has become difficult.
The endpoint of this study is to determine the actual incidence of respiratory postoperative complications in patients undergoing general anesthesia for major abdominal surgery (general surgery, gynecology, urology).
This is an observational, descriptive, prospective, multicentric study. Investigators are going to enroll all the patients matching the inclusion criteria and follow them until discharge (clinical phase). Then they will be followed up until one year later.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients ≥ 18 years
* Ability to provide informed consent
* Elective surgery
* Laparotomic or laparoscopic major abdominal surgery
* Major urological surgery (performed under general anesthesia)
* Major gynecological surgery (performed under general anesthesia)
Exclusion Criteria:
* Patients undergoing urgent or emergent surgery
* Patients undergoing: vascular, thoracic ,cardiac surgery, neurosurgery, obstetrics procedures and transplantation surgery
* Patients with chronic neuro-muscular junction disorders
* Immunocompromised or immunodepressed patients
* Patients with chronic or acute respiratory disease (acute respiratory infection, bronchial asthma, chronic obstructive pulmonary disease, sleep apnea syndrome)
* Patients with preoperative mechanical ventilation
* Patients with preoperative SpO2 \<90%, PaO2 \<60 mmHg (FiO2 0.21), or a PaO2/FiO2 ratio \<300, or PaCO2 \>45 mmHg.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Postoperative pulmonary complications rate
Timeframe: From surgery to hospital discharge (an average of 10 days)