- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06958900
- Original Trial
Effect of Malignancy on Morbidity and Mortality in Left-sided Emergency Colorectal Resections
Study Overview
Status
Detailed Description
Patients in a single center between January 2023 and May 2024 were included in this retrospective observational study. Included patients who were 18 years old or older and underwent emergency left-sided colorectal resection due to isolated colorectal pathology. Patients with diseases originated from a colonic segment proximal to left colon, surgeries performed for combined organ pathologies for various benign and malignant causes and those undergoing reoperation caused by complication of elective abdominal surgery were excluded Data of patients obtained via the hospital software system. Demographic data, Charlson comorbidity index (CCI) score and baseline characteristics, operative and postoperative results, primary anastomosis or end colostomy preference, length of hospital stay, presence of perforation and and benign or malign etiologies were investigated. Morbidity was defined as Clavien Dindo grade III or higher complication.
Risk factors for both morbidity and mortality were first evaluated using univariate analyzes. In univariate analysis for morbidity, patients divided two subgroups as patient with morbidity and the others without morbidity. After that these two subgroups compared in terms of all variables. For univariate mortality analysis also, patients divided again according to dying in first 90 days postoperatively or not. After that these mortality and alive subgroups analysed in terms of all variables. Pearson Chi Square, Student's t-test and Mann Whitney U tests were used when appropriate. Decision for normal distribution was given according to Kolmogorov- Smirnov test. Values for normally distributed variables expressed as mean±standard deviation (SD). Categorical variables are expressed as number and percentage. The variables that not showed a normal distribution expressed as median and 25-75 interquartile range values. The effects of risk factors on morbidity and mortality were expressed as the odds ratio with their 95% confidence intervals (CI). Statistical significance level was set at 0.05. The data were compiled and analyzed using the software SPSS for Windows, version 29.0 (SPSS, Chicago, IL)
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Istanbul, Turkey, 34303
- University of Health Sciences, Kanuni Sultan Suleyman Training and Research Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients who were 18 years old or older and underwent emergency left-sided colorectal resection due to isolated colorectal pathology
Exclusion Criteria:
- Patients with diseases originated from a colonic segment proximal to left colon, surgeries performed for combined organ pathologies for various benign and malignant causes and those undergoing reoperation caused by complication of elective abdominal surgery
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
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Emergency Left-Sided Colorectal Resections
Patients in a single center underwent emergency left-sided colorectal resection due to benign or malign colorectal pathology
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Morbidity
Time Frame: Postoperative 30 days
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Morbidity was defined as Clavien Dindo grade III or higher postoperative complication.
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Postoperative 30 days
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2024-166
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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