Tracheal Colonization and Outcome After Major Abdominal Cancer Surgery

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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Tracheal Colonization and Outcome After Major Abdominal Cancer Surgery

Conditions
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Colorectal Neoplasms Malignant, Surgical Procedures, Operative, Stomach Neoplasms, Pancreatic Cancer, Adult

Intervention / Treatment
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* Other: Tracheal aspirates and nasal smears were taken in all the patients. Laparotomies were performed in all patients.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients diagnosis of gastric cancer, or colorectal cancer or pancreatic cancer Scheduled for major abdominal surgery with organ resections Written informed consent Nasopharyngeal smears taken in the preoperative area Tracheal aspirates taken at the end of the surgical procedure Exclusion Criteria: Patients unable to understand study protocol and patients who refused study participation at any time patients with clinically or radiologically confirmed acute respiratory infections at admission antibiotic therapy due to the respiratory infections a week prior to the surgery

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: To investigate whether productive cough, dyspnea and hoarseness were different between two groups of patients. Group Air received sevoflurane anesthesia with 35% O2 in air, and Group N2O received sevoflurane anesthesia with 35% O2 in N2O
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Group air<br>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 maintained during the surgical procedure. Intraoperative analgesia was achieved with fentanyl boluses. | Other: Tracheal aspirates and nasal smears were taken in all the patients. Laparotomies were performed in all patients.<br>* Nitrous oxyde and sevoflurane anesthesia may alter mucus transport in the early postoperative period. In colonized patients it may result in more respiratory complications.<br>|
| Active Comparator: Group nitrous oxyde (N2O)<br>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, hoarseness and postoperative cough. Thiopental sodium was used for induction of anesthesia, muscle relaxation was maintained with vecuronium. General anesthesia with sevoflurane was maintained during the surgical procedure. Intraoperative analgesia was achieved with fentanyl boluses. | Other: Tracheal aspirates and nasal smears were taken in all the patients. Laparotomies were performed in all patients.<br>* Nitrous oxyde and sevoflurane anesthesia may alter mucus transport in the early postoperative period. In colonized patients it may result in more respiratory complications.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tracheal colonization;, Bacteria;, Survival, Anesthesia, General;