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Completed

NCT Number: NCT04002128

Tracheal Colonization and Outcome After Major Abdominal Cancer Surgery

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.

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Key information

Conditions

Colorectal Neoplasms Malignant Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Pancreatic Cancer, Adult Stomach Diseases Stomach Neoplasms Surgical Procedures, Operative

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tracheal aspirates and nasal smears were taken in all the patients. Laparotomies were performed in all patients.

Other

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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Osijek University Hospital

Other

Collaborators

  • Josip Juraj Strossmayer University of Osijek

Registry information

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
Jun 28, 2019
Registry last updated
Apr 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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