NCT04002128

Tracheal Colonization and Outcome After Major Abdominal Cancer Surgery

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Osijek University Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

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

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

Conditions

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

Interventions

Type	Name	Description
OTHER	Tracheal aspirates and nasal smears were taken in all the patients. Laparotomies were performed in all patients.	Nitrous oxyde and sevoflurane anesthesia may alter mucus transport in the early postoperative period. In colonized patients it may result in more respiratory complications.

Timeline

• Start date: 2008-01-01
• Primary completion: 2012-03-01
• Completion: 2012-03-01
• First posted: 2019-06-28
• Last updated: 2024-04-23