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2008-01
2012-03
2012-03
120
NCT04002128
Osijek University Hospital
Osijek University Hospital
INTERVENTIONAL
Tracheal Colonization and Outcome After Major Abdominal Cancer Surgery
The goals of this study were to investigate whether two anesthesia regimens, with and without N2O, and bacterial colonization influence respiratory complications after major abdominal surgery for cancer.
A study was approved by institutional ethics committee. All patients were informed on the study protocol by attending anesthesiologist on the day of the surgery and written informed consent was obtained. Patients with clinically or radiologically confirmed acute respiratory infections or those using antibiotics due to the respiratory infections a week prior to the surgery were not included in the study. Following risk factors were recorded in all patients: age, sex, weight loss in the last 6 months, comorbidities and operative time. Comorbidities were rated using ASA status and Charlson comorbidity index by 3 independent observers. Charlson comorbidity index was calculated after pathological examination. An advanced malignant disease was considered if tumor had infiltrated other organs or surrounding tissues, or when positive lymph nodes or metastases were confirmed. A group of 120 colorectal, gastric, or pancreatic cancer patients scheduled for surgery in the single centre were included in the prospective randomized study regardless of their ASA physical status. Nasopharyngeal smears were obtained in the preoperative area and tracheal aspirates were obtained in the operating room at the end of the surgery with a sterile suction catheter in a closed system. Postoperative Hgb; CRP and lung auscultation were done in all patients on the second and fourth postoperative day. Outcome measures registered were: * Postoperative pneumonia * Productive and difficult cough * Dysphonia * Congestive heart failure * postoperative complications, including hypertensive crisis, thromboembolic and infective complications were summarized one year after surgical treatment was finished & one year survival
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2019-06-24 | N/A | 2024-04-22 |
2019-06-26 | N/A | 2024-04-23 |
2019-06-28 | N/A | 2019-06 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Screening
Allocation:
Randomized
Interventional Model:
Parallel
Masking:
Triple
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| PLACEBO_COMPARATOR: Group air Group air was mechanically ventilated using 35% oxygen in 65% air during the whole surgical procedure. Thiopental sodium was used for induction of anesthesia, muscle relaxation was maintained with vecuronium. General anesthesia with sevoflurane was maint | OTHER: Tracheal aspirates and nasal smears were taken in all the patients. Laparotomies were performed in all patients.
|
| ACTIVE_COMPARATOR: Group nitrous oxyde (N2O) Group N2O was mechanically ventilated using 35 % oxygen and 65 % of nitrous oxyde during the surgical procedure. Nitrous oxyde may increase cuff pressure during the general endotracheal anesthesia and result in the respiratory symptoms like sore throat, | OTHER: Tracheal aspirates and nasal smears were taken in all the patients. Laparotomies were performed in all patients.
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Number of the patients with postoperative pneumonia | Number of patients who reported the presence of cough, dyspnea and/or abnormal findings on lung examination, and two of following: fever, leukocytosis or high CRP, and positive chest radiograms. | Postoperative day 4 |
| Number of the patients with productive cough and difficult expectoration | patients without auscultatory findings who self reported that they have productive sputum and painful expectoration without laboratory and RTG findings suggestive for pneumonia | Postoperative day 4 |
| Number of the patients with hoarseness | The patients who self-reported hoarseness and changed voice | Postoperative day 4 |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| One year survival and complications | All the other postoperative complications, including in-hospital hypertensive crisis, thromboembolic and infective complications were summarized one year after surgical treatment was finished. | One postoperative year |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
