Colorectal Neoplasms MalignantNCT04002128
Tracheal Colonization and Outcome After Major Abdominal Cancer Surgery
A study testing Tracheal aspirates and nasal smears were taken in all the patients. Laparotomies were performed in all patients. in people with Colorectal Neoplasms Malignant and Surgical Procedures, Operative, run by Osijek University Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Colorectal Neoplasms Malignant, Surgical Procedures, Operative, Stomach Neoplasms
- What is being tested?
- Tracheal aspirates and nasal smears were taken in all the patients. Laparotomies were performed in all patients.
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Jan 2008to Mar 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
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.
Read the 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
- Being tested
- Tracheal aspirates and nasal smears were taken in all the patients. Laparotomies were performed in all patients.
- Keywords
- tracheal colonization;, Bacteria;, Survival, Anesthesia, General;
- Medical subject headings
- Colonic Neoplasms, Stomach Neoplasms, Pancreatic cancer, adult
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Group air | Placebo comparator | 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. Receives: Other: Tracheal aspirates and nasal smears were taken in all the patients. Laparotomies were performed in all patients. |
| Group nitrous oxyde (N2O) | Active comparator | 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. Receives: Other: Tracheal aspirates and nasal smears were taken in all the patients. Laparotomies were performed in all patients. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Postoperative day 4
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
Measured: Postoperative day 4
Number of the patients with hoarseness
The patients who self-reported hoarseness and changed voice
Measured: Postoperative day 4
Secondary outcomes (1)
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.
Measured: One postoperative year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2019
- Study startJan 2008
- Primary completionMar 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Colorectal Neoplasms MalignantStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Osijek University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Josip Juraj Strossmayer University of Osijek
- Responsible party
- Sponsor
- Investigators
- Slavica Kvolik, MD, PhD, Principal investigator, Osijek University Hospital, J. Huttlera 4, 31 000 Osijek, Croatia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04002128
- Sponsor's protocol ID
- 01
- Status last verified
- Jun 2019
- First submitted
- 24 Jun 2019
- Last updated
- 23 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Upon the request all blinded individual participant data (IPD) may be available to other researchers
Publications
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.
PubMed 26259742Fernandez-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.
PubMed 27829093de 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.
PubMed 11412514Payne 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.
PubMed 8494136Braz 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.
PubMed 15374551
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tracheal Colonization and Outcome After Major Abdominal Cancer Surgery
- ClinicalTrials.gov ID
- NCT04002128
- Acronym / sponsor ID
- 01
- Conditions
- Colorectal Neoplasms Malignant, Surgical Procedures, Operative, Stomach Neoplasms, Pancreatic Cancer, Adult
- Keywords
- tracheal colonization;, Bacteria;, Survival, Anesthesia, General;
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Osijek University HospitalUniversity, hospital or other
- Collaborators
- Josip Juraj Strossmayer University of Osijek
- Study start
- Jan 2008
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 28 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Group air | Placebo comparator | Other: Tracheal aspirates and nasal smears were taken in all the patients. Laparotomies were performed in all patients.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 nitrous oxyde (N2O) | Active comparator | Other: Tracheal aspirates and nasal smears were taken in all the patients. Laparotomies were performed in all patients.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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Group air, Group nitrous oxyde (N2O) |
Primary outcome
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.
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
Number of the patients with hoarseness
Time frame: Postoperative day 4
The patients who self-reported hoarseness and changed voice
1 secondary outcome
One year survival and complications
Time frame: One postoperative year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2024.
- Background: PubMed 26259742Evaristo-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.
- Background: PubMed 27829093Fernandez-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.
- Background: PubMed 11412514de 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.
- Background: PubMed 8494136Payne 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.
- Background: PubMed 15374551Braz 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.
- Individual participant dataSharing planned: Yes. Upon the request all blinded individual participant data (IPD) may be available to other researchers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Slavica Kvolik, MD, PhD principal investigator
Osijek University Hospital, J. Huttlera 4, 31 000 Osijek, Croatia
Questions about this trial
What is this clinical trial studying?
A study testing Tracheal aspirates and nasal smears were taken in all the patients. Laparotomies were performed in all patients. in people with Colorectal Neoplasms Malignant and Surgical Procedures, Operative, run by Osijek University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of the patients with postoperative pneumonia (time frame: Postoperative day 4). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04002128, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2024.