Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Tracheal Colonization and Outcome After Major Abdominal Cancer Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04002128
Recruitment Status : Completed
First Posted : June 28, 2019
Last Update Posted : July 2, 2019
Sponsor:
Collaborator:
Josip Juraj Strossmayer University of Osijek
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Colorectal Neoplasms Malignant Surgical Procedures, Operative Stomach Neoplasms Pancreatic Cancer, Adult Other: Tracheal aspirates and nasal smears were taken in all the patients. Laparotomies were performed in all patients. Not Applicable

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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 (Participant, Care Provider, Outcomes Assessor)
Masking Description: Postoperative outcomes were registered by doctor who did not know type of anesthesia delivered
Primary Purpose: Screening
Official Title: Tracheal Colonization and Outcome After Major Abdominal Cancer Surgery
Study Start Date : January 2008
Actual Primary Completion Date : March 2012
Actual Study Completion Date : March 2012

Resource links provided by the National Library of Medicine


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 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.
Nitrous oxyde and sevoflurane anesthesia may alter mucus transport in the early postoperative period. In colonized patients it may result in more respiratory complications.

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, 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.
Nitrous oxyde and sevoflurane anesthesia may alter mucus transport in the early postoperative period. In colonized patients it may result in more respiratory complications.




Primary Outcome Measures :
  1. Number of the patients with postoperative pneumonia [ Time Frame: 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.

  2. Number of the patients with productive cough and difficult expectoration [ Time Frame: 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

  3. Number of the patients with hoarseness [ Time Frame: Postoperative day 4 ]
    The patients who self-reported hoarseness and changed voice


Secondary Outcome Measures :
  1. One year survival and complications [ Time Frame: 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04002128


Sponsors and Collaborators
Osijek University Hospital
Josip Juraj Strossmayer University of Osijek
Investigators
Layout table for investigator information
Principal Investigator: Slavica Kvolik, MD, PhD Osijek University Hospital, J. Huttlera 4, 31 000 Osijek, Croatia
Publications:
Layout table for additonal information
Responsible Party: Osijek University Hospital
ClinicalTrials.gov Identifier: NCT04002128    
Other Study ID Numbers: 01
First Posted: June 28, 2019    Key Record Dates
Last Update Posted: July 2, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Upon the request all blinded individual participant data (IPD) may be available to other researchers
Supporting Materials: Clinical Study Report (CSR)
Time Frame: Upon the request
Access Criteria: Shared by principal investigator directly

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Osijek University Hospital:
tracheal colonization;
Bacteria;
Survival
Anesthesia, General;
Additional relevant MeSH terms:
Layout table for MeSH terms
Neoplasms
Colorectal Neoplasms
Stomach Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Intestinal Neoplasms
Gastrointestinal Neoplasms
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Stomach Diseases