Colorectal CancerNCT01707511
The Investigation of the EtCO₂- PaCO₂ Relation During Laparoscopic Colon Surgery
An observational study of Colorectal Cancer, run by Diskapi Teaching and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Et-C02 is used to predict PaCO2 during surgery. There are controversies regarding the value of ETCO2 to predict PaCO2. The aim of this study was to investigate the relation between Et-CO₂ and PaCO₂ measurements in patients undergoing laparoscopic colorectal surgery. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Colorectal Cancer
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jan 2012to Dec 2013
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients scheduled whom planned for elective laparoscopic colorectal resection.
Who may be able to join
- ASA I-III patients underwent laparoscopic colorectal resection
Who cannot join
- convertion to the open surgery
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Diskapi Teaching and Research Hospital
Ankara, Altindag, 06110
Dilek Yazicioglu, specialist, +903125962553
Mustafa Ozmen, assistant
About this study
Official title: Cohort Study on Patients Underwent Colorectal Surgery
Et-C02 is used to predict PaCO2 during surgery. There are controversies regarding the value of ETCO2 to predict PaCO2. The aim of this study was to investigate the relation between Et-CO₂ and PaCO₂ measurements in patients undergoing laparoscopic colorectal surgery. Patient and surgical characteristics, mechanical ventilation adjustments, and intraabdominal pressure values and the corelation between these parameters and EtCO₂ - PaCO₂ difference were also investigated.
Read the detailed description
Patient records from patients underwent colorectal surgery between 2010-2011 will be studied. It was planned to include patients undergoing laparoscopic colorectal surgery with a predetermined anaesthesia protocol.
Patients will receive a standardized general anesthetic and thoracal epidural anaesthesia. Ventilatory parameters will be adjusted to maintain ETCO2 35 mmHg, Paw 25 cmH2O.Patient age, gen-der, BMI, ASA classification, the duration of surgery, anesthesia, Trendelenburg position and pneumoperitoneum. Hemodynamic parameters, blood gas analyzes, ventilation parameters and EtCO₂ values will be recorded. We determined 6 timelines to compare the difference between PaCO₂ and EtCO₂. These timelines were the times where we could collect the most data regarding blood gas analyzes. Preoperative period: to, 10th minute after the first insuflation and trendelendburg position: t₁,the first hour after the first insuflation and trendelendburg position: t₂, 10th minute after desuflation and supine position: t₃, 10th minute after the second insuflation and trendelendburg position: t₄, and 10th minute after the second desuflation and supine position:t₅. Primary outcome measure is the difference between PaCO₂ and EtCO₂ a difference greater than 5 mmHg was assumed to be important.
- Conditions
- Colorectal Cancer
- Keywords
- Arterial carbondioxide pressure, Colon surgery, End-tidal carbondioxide, Laparoscopic Trendelenburg
- Medical subject headings
- Colorectal Neoplasms
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2012 (estimated)
- Study startJan 2012
- Primary completionMar 2012
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Diskapi Teaching and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mustafa Ozmen, Diskapi Teaching and Research Hospital
- Investigators
- Mustafa Ozmen, MD, Principal investigator, Diskapi Yildirim Beyazit Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01707511
- Sponsor's protocol ID
- Diskapianesthesia-01
- Status last verified
- Oct 2012
- First submitted
- 15 Sep 2012
- Last updated
- 16 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cohort Study on Patients Underwent Colorectal Surgery
- ClinicalTrials.gov ID
- NCT01707511
- Acronym / sponsor ID
- Diskapianesthesia-01
- Conditions
- Colorectal Cancer
- Keywords
- Arterial carbondioxide pressure, Colon surgery, End-tidal carbondioxide, Laparoscopic Trendelenburg
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Diskapi Teaching and Research HospitalUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Mar 2012 (actual)
- Study completion
- Dec 2013 (estimated)
- First posted
- 16 Oct 2012 (estimated)
- 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.
Et-C02 is used to predict PaCO2 during surgery. There are controversies regarding the value of ETCO2 to predict PaCO2. The aim of this study was to investigate the relation between Et-CO₂ and PaCO₂ measurements in patients undergoing laparoscopic colorectal surgery. Patient and surgical characteristics, mechanical ventilation adjustments, and intraabdominal pressure values and the corelation between these parameters and EtCO₂ - PaCO₂ difference were also investigated.
Detailed description
Patient records from patients underwent colorectal surgery between 2010-2011 will be studied. It was planned to include patients undergoing laparoscopic colorectal surgery with a predetermined anaesthesia protocol.
Patients will receive a standardized general anesthetic and thoracal epidural anaesthesia. Ventilatory parameters will be adjusted to maintain ETCO2 35 mmHg, Paw 25 cmH2O.Patient age, gen-der, BMI, ASA classification, the duration of surgery, anesthesia, Trendelenburg position and pneumoperitoneum. Hemodynamic parameters, blood gas analyzes, ventilation parameters and EtCO₂ values will be recorded. We determined 6 timelines to compare the difference between PaCO₂ and EtCO₂. These timelines were the times where we could collect the most data regarding blood gas analyzes. Preoperative period: to, 10th minute after the first insuflation and trendelendburg position: t₁,the first hour after the first insuflation and trendelendburg position: t₂, 10th minute after desuflation and supine position: t₃, 10th minute after the second insuflation and trendelendburg position: t₄, and 10th minute after the second desuflation and supine position:t₅. Primary outcome measure is the difference between PaCO₂ and EtCO₂ a difference greater than 5 mmHg was assumed to be important.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients scheduled whom planned for elective laparoscopic colorectal resection.
Key inclusion criteria (1 listed)
- ASA I-III patients underwent laparoscopic colorectal resection
Key exclusion criteria (1 listed)
- convertion to the open surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2012.
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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.
Mustafa Ozmen, MD principal investigator
Diskapi Yildirim Beyazit Education and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer, run by Diskapi Teaching and Research Hospital at 1 site in Turkey (Türkiye).
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 16 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
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 16 Oct 2012.