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Tracheal Colonization and Outcome After Major Abdominal Cancer Surgery

Primary Purpose

Colorectal Neoplasms Malignant, Surgical Procedures, Operative, Stomach Neoplasms

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Tracheal aspirates and nasal smears were taken in all the patients. Laparotomies were performed in all patients.
Sponsored by
Osijek University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Colorectal Neoplasms Malignant focused on measuring tracheal colonization;, Bacteria;, Survival, Anesthesia, General;

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Placebo Comparator

    Active Comparator

    Arm Label

    Group air

    Group nitrous oxyde (N2O)

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    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.
    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
    Number of the patients with hoarseness
    The patients who self-reported hoarseness and changed voice

    Secondary Outcome Measures

    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.

    Full Information

    First Posted
    June 24, 2019
    Last Updated
    June 28, 2019
    Sponsor
    Osijek University Hospital
    Collaborators
    Josip Juraj Strossmayer University of Osijek
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04002128
    Brief Title
    Tracheal Colonization and Outcome After Major Abdominal Cancer Surgery
    Official Title
    Tracheal Colonization and Outcome After Major Abdominal Cancer Surgery
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2008 (undefined)
    Primary Completion Date
    March 2012 (Actual)
    Study Completion Date
    March 2012 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Osijek University Hospital
    Collaborators
    Josip Juraj Strossmayer University of Osijek

    4. Oversight

    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
    Data Monitoring Committee
    No

    5. Study Description

    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Colorectal Neoplasms Malignant, Surgical Procedures, Operative, Stomach Neoplasms, Pancreatic Cancer, Adult
    Keywords
    tracheal colonization;, Bacteria;, Survival, Anesthesia, General;

    7. Study Design

    Primary Purpose
    Screening
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    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
    ParticipantCare ProviderOutcomes Assessor
    Masking Description
    Postoperative outcomes were registered by doctor who did not know type of anesthesia delivered
    Allocation
    Randomized
    Enrollment
    120 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Group air
    Arm Type
    Placebo Comparator
    Arm Description
    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.
    Arm Title
    Group nitrous oxyde (N2O)
    Arm Type
    Active Comparator
    Arm Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Tracheal aspirates and nasal smears were taken in all the patients. Laparotomies were performed in all patients.
    Intervention Description
    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 Measure Information:
    Title
    Number of the patients with postoperative pneumonia
    Description
    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.
    Time Frame
    Postoperative day 4
    Title
    Number of the patients with productive cough and difficult expectoration
    Description
    patients without auscultatory findings who self reported that they have productive sputum and painful expectoration without laboratory and RTG findings suggestive for pneumonia
    Time Frame
    Postoperative day 4
    Title
    Number of the patients with hoarseness
    Description
    The patients who self-reported hoarseness and changed voice
    Time Frame
    Postoperative day 4
    Secondary Outcome Measure Information:
    Title
    One year survival and complications
    Description
    All the other postoperative complications, including in-hospital hypertensive crisis, thromboembolic and infective complications were summarized one year after surgical treatment was finished.
    Time Frame
    One postoperative year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Slavica Kvolik, MD, PhD
    Organizational Affiliation
    Osijek University Hospital, J. Huttlera 4, 31 000 Osijek, Croatia
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    Upon the request all blinded individual participant data (IPD) may be available to other researchers
    IPD Sharing Time Frame
    Upon the request
    IPD Sharing Access Criteria
    Shared by principal investigator directly
    Citations:
    PubMed Identifier
    26259742
    Citation
    Evaristo-Mendez G, Rocha-Calderon CH. [Risk factors for nosocomial pneumonia in patients with abdominal surgery]. Cir Cir. 2016 Jan-Feb;84(1):21-7. doi: 10.1016/j.circir.2015.05.051. Epub 2015 Aug 8. Spanish.
    Results Reference
    background
    PubMed Identifier
    27829093
    Citation
    Fernandez-Bustamante A, Frendl G, Sprung J, Kor DJ, Subramaniam B, Martinez Ruiz R, Lee JW, Henderson WG, Moss A, Mehdiratta N, Colwell MM, Bartels K, Kolodzie K, Giquel J, Vidal Melo MF. Postoperative Pulmonary Complications, Early Mortality, and Hospital Stay Following Noncardiothoracic Surgery: A Multicenter Study by the Perioperative Research Network Investigators. JAMA Surg. 2017 Feb 1;152(2):157-166. doi: 10.1001/jamasurg.2016.4065.
    Results Reference
    background
    PubMed Identifier
    11412514
    Citation
    de Albuquerque Medeiros R, Faresin S, Jardim J. [Postoperative lung complications and mortality in patients with mild-to-moderate COPD undergoing elective general surgery]. Arch Bronconeumol. 2001 May;37(5):227-34. doi: 10.1016/s0300-2896(01)75059-4. Spanish.
    Results Reference
    background
    PubMed Identifier
    8494136
    Citation
    Payne KA, Miller DM. The Miller tracheal cuff pressure control valve. Clinical use in controlled and spontaneous ventilation. Anaesthesia. 1993 Apr;48(4):324-7. doi: 10.1111/j.1365-2044.1993.tb06954.x.
    Results Reference
    background
    PubMed Identifier
    15374551
    Citation
    Braz JR, Volney A, Navarro LH, Braz LG, Nakamura G. Does sealing endotracheal tube cuff pressure diminish the frequency of postoperative laryngotracheal complaints after nitrous oxide anesthesia? J Clin Anesth. 2004 Aug;16(5):320-5. doi: 10.1016/j.jclinane.2004.03.001.
    Results Reference
    background

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    Tracheal Colonization and Outcome After Major Abdominal Cancer Surgery

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