Tracheal Colonization and Outcome After Major Abdominal Cancer Surgery

Not Applicable

Completed

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

• Registration Number: NCT04002128
• Lead Sponsor: Osijek University Hospital

Brief 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

Study Timeline

• Study Start: 2008-01
• Primary Completion: 2012-03
• Study Completion: 2012-03
• Status Verified: 2019-06
• Study First Submitted: 2019-06-24
• Study First Submitted QC: 2019-06-26
• Study First Posted: 2019-06-28
• Last Update Submitted: 2024-04-22
• Last Update Posted: 2024-04-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Number of the patients with productive cough and difficult expectoration	Postoperative day 4	patients without auscultatory findings who self reported that they have productive sputum and painful expectoration without laboratory and RTG findings suggestive for pneumonia
Number of the patients with postoperative pneumonia	Postoperative day 4	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.
Number of the patients with hoarseness	Postoperative day 4	The patients who self-reported hoarseness and changed voice

Secondary Outcome Measures

Name	Time	Method
One year survival and complications	One postoperative year	All the other postoperative complications, including in-hospital hypertensive crisis, thromboembolic and infective complications were summarized one year after surgical treatment was finished.