An observational study in Colon Cancer and Anesthesia, sponsored by Ankara City Hospital Bilkent. Status unknown. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2022-04-19.
Sponsored by Ankara City Hospital Bilkent · Observational
Anesthesia management in colon cancer surgery affects the postoperative mobilization, discharge and oral intake times of the patients. Due to the side effects of opioids, their use is tried to be reduced and therefore regional anesthesia methods are preferred in suitable patients. Especially in the preoperative period, opioid use has a negative effect on the recovery processes, morbidity and mortality of the patients. Epidural analgesia, a central block method, is recommended for postoperative pain control in ERAS protocols. Opioids suppress cellular and humoral immunity. Epidural analgesia reduces both opioid consumption and surgical stress response. It has been shown that epidural analgesia maintains the immune functions of patients and is associated with a decrease in tumor recurrence. It has also been shown to reduce postoperative pain, hypercoagulability and pulmonary complications, increase exercise capacity and accelerate the return of intestinal functions to normal. In line with this information, in this study, it was aimed to investigate the differences in the postoperative period in patients managed with regional anesthesia.
In the study, it was planned to create two groups who underwent open surgery for colon cancer. The first group will be operated under general anesthesia and the second group will be operated under combined spinal-epidural anesthesia with ketofol sedation. An epidural catheter will be inserted in both groups for postoperative pain management. In the study, patients' age, gender, weight, comorbidity, ASA score, amount of local anesthetic used, postoperative VAS scores, mobilization time, time to start oral intake, nasogastric withdrawal time, drain removal time, urinary catheter withdrawal time, hospitalization time and total cost will be evaluated.
1,485 studies on the registry are indexed under Colonic Neoplasms; 362 are open to participants now.
This study's planned enrollment of 60 is below the median of 262 across 363 observational studies indexed under Colonic Neoplasms.
Browse Colonic Neoplasms studies →Ankara City Hospital Bilkent is the lead sponsor of 437 studies on the registry; 109 are open to participants now.
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Patients over 40 years of age who are scheduled for open surgery with a diagnosis of colon cancer.
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Exclusion Criteria:
Patients in this group will undergo open colon cancer surgery under general anesthesia. Epidural catheterization will be applied for postoperative analgesia.
Patients in this group will undergo open colon cancer surgery under combined spinal-epidural anesthesia with ketofol sedation. Epidural catheterization will be applied for postoperative analgesia.
Other: combined spinal-epidural anesthesia
Combined spinal and epidural anaesthesia is a regional anaesthetic technique, which combines the benefits of both spinal anaesthesia and epidural anaesthesia and analgesia. The spinal component gives a rapid onset of a predictable block. The indwelling epidural catheter gives the ability to provide long lasting analgesia and to titrate the dose given to the desired effect.
visual analog scale (VAS)
A patient is asked to indicate his/her perceived pain intensity (most commonly) along a 5 cm horizontal line (between 0 and 5 points, 0 meaning 'no pain' and 5 meaning the worst) and this rating is then measured from the left edge (=Visual Analog Scale score).
Time frame: postoperative 2nd hour.
visual analog scale (VAS)
A patient is asked to indicate his/her perceived pain intensity (most commonly) along a 5 cm horizontal line (between 0 and 5 points, 0 meaning 'no pain' and 5 meaning the worst) and this rating is then measured from the left edge (=Visual Analog Scale score).
Time frame: postoperative 4th hour.
visual analog scale (VAS)
A patient is asked to indicate his/her perceived pain intensity (most commonly) along a 5 cm horizontal line (between 0 and 5 points, 0 meaning 'no pain' and 5 meaning the worst) and this rating is then measured from the left edge (=Visual Analog Scale score).
Time frame: postoperative 8th hour.
visual analog scale (VAS)
A patient is asked to indicate his/her perceived pain intensity (most commonly) along a 5 cm horizontal line (between 0 and 5 points, 0 meaning 'no pain' and 5 meaning the worst) and this rating is then measured from the left edge (=Visual Analog Scale score).
Time frame: postoperative 12th hour.
visual analog scale (VAS)
A patient is asked to indicate his/her perceived pain intensity (most commonly) along a 5 cm horizontal line (between 0 and 5 points, 0 meaning 'no pain' and 5 meaning the worst) and this rating is then measured from the left edge (=Visual Analog Scale score).
Time frame: postoperative16th hour.
visual analog scale (VAS)
A patient is asked to indicate his/her perceived pain intensity (most commonly) along a 5 cm horizontal line (between 0 and 5 points, 0 meaning 'no pain' and 5 meaning the worst) and this rating is then measured from the left edge (=Visual Analog Scale score).
Time frame: postoperative 24th hour.
time to start oral intake
the time the patient start to consume orally after the operation
Time frame: to be observed until the start of oral intake after the operation. it will be assessed up to 720 hours.
mobilization time
the time the patient was start to walk after the operation
Time frame: to be observed until the start of walking after the operation. it will be assessed up to 720 hours.
urinary catheter withdrawal time
the time the urinary catheter was withdrawn after the operation
Time frame: to be observed until the withdrawal of urinary catheter after the operation. it will be assessed up to 720 hours.
hospitalization time
The time from the day the patient was hospitalized before the operation to the day of discharge after the operation.
Time frame: from hospitalization for the operation to the day of discharge, it will be assessed up to 30 days.
nasogastric withdrawal time
the time the nasogastric tube was withdrawn after the operation.
Time frame: to be observed until the withdrawal of nasogastric tube after the operation. it will be assessed up to 720 hours.
drain removal time
the time the abdominal drain was withdrawn after the operation.
Time frame: to be observed until the withdrawal of abdominal drain after the operation. it will be assessed up to 720 hours.
complications
all complications related with surgery or anesthesia
Time frame: to be observed for 30 days postoperatively.
blood pressure
patients' mean arterial pressure levels
Time frame: preoperatively
blood pressure
patients' mean arterial pressure levels
Time frame: perioperatively. "30 minutes" will be taken as the measurement period.
FiCO2
inspiratory carbondioxide level
Time frame: preoperatively
FiCO2
inspiratory carbondioxide level
Time frame: perioperatively. "30 minutes" will be taken as the measurement period.
sPO2
oxygene saturation
Time frame: preoperatively
sPO2
oxygene saturation
Time frame: perioperatively. "30 minutes" will be taken as the measurement period.
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This study is status unknown, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
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