Emergency Abdominal SurgeryNCT06958900
Effect of Malignancy on Morbidity and Mortality in Left-sided Emergency Colorectal Resections
An observational study of Emergency Abdominal Surgery and Colorectal Surgery, run by Kanuni Sultan Suleyman Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Patients who underwent emergency left sided colorectal resection in a single center between January 2023 and May 2024 were included. Demographics, Charlson comorbidity index, perforation, duration of surgery, primary anastomosis or end colostomy preference and benign or malign etiologies were examined. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Emergency Abdominal Surgery, Colorectal Surgery, Acute Diverticulitis
- How many people
- 76 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2024to 1 Oct 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who were 18 years old or older and underwent emergency left-sided colorectal resection due to isolated colorectal pathology
Who may be able to join
- Patients who were 18 years old or older and underwent emergency left-sided colorectal resection due to isolated colorectal pathology
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
University of Health Sciences, Kanuni Sultan Suleyman Training and Research Hospital
Istanbul, 34303
About this study
Patients who underwent emergency left sided colorectal resection in a single center between January 2023 and May 2024 were included. Demographics, Charlson comorbidity index, perforation, duration of surgery, primary anastomosis or end colostomy preference and benign or malign etiologies were examined. Morbidity was defined as Clavien Dindo grade III or higher complication. Risk factors for both morbidity and mortality were first evaluated with univariate analyzes. Then multivariable logistic regression tests were performed for both morbidity and mortality.
Read the 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)
- Keywords
- Colorectal Cancer, Emergency Surgery, Morbidity, Mortality
- Medical subject headings
- Intestinal Volvulus, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Emergency Left-Sided Colorectal Resections | Patients in a single center underwent emergency left-sided colorectal resection due to benign or malign colorectal pathology |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morbidity
Morbidity was defined as Clavien Dindo grade III or higher postoperative complication.
Measured: Postoperative 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2025
- Study start1 Sep 2024
- Primary completion1 Oct 2024
- Study completion1 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emergency Abdominal SurgeryStudies 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
- Retrospective
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasir Musa Kesgin, MD, Kanuni Sultan Suleyman Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06958900
- Sponsor's protocol ID
- 2024-166
- Status last verified
- Jan 2025
- First submitted
- 24 Jan 2025
- Last updated
- 6 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Malignancy on Morbidity and Mortality in Left-sided Emergency Colorectal Resections
- ClinicalTrials.gov ID
- NCT06958900
- Acronym / sponsor ID
- 2024-166
- Keywords
- Colorectal Cancer, Emergency Surgery, Morbidity, Mortality
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 1 Oct 2024 (actual)
- Study completion
- 1 Oct 2024 (actual)
- First posted
- 6 May 2025 (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.
Patients who underwent emergency left sided colorectal resection in a single center between January 2023 and May 2024 were included. Demographics, Charlson comorbidity index, perforation, duration of surgery, primary anastomosis or end colostomy preference and benign or malign etiologies were examined. Morbidity was defined as Clavien Dindo grade III or higher complication. Risk factors for both morbidity and mortality were first evaluated with univariate analyzes. Then multivariable logistic regression tests were performed for both morbidity and mortality.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Emergency Left-Sided Colorectal Resections | – | –Patients in a single center underwent emergency left-sided colorectal resection due to benign or malign colorectal pathology |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who were 18 years old or older and underwent emergency left-sided colorectal resection due to isolated colorectal pathology
Key inclusion criteria (1 listed)
- Patients who were 18 years old or older and underwent emergency left-sided colorectal resection due to isolated colorectal pathology
Key exclusion criteria (1 listed)
- 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
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
Morbidity
Time frame: Postoperative 30 days
Morbidity was defined as Clavien Dindo grade III or higher postoperative complication.
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 6 May 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Emergency Abdominal Surgery and Colorectal Surgery, run by Kanuni Sultan Suleyman Training 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: finished, as of the sponsor's last update on 6 May 2025. 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?
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?
Morbidity (time frame: Postoperative 30 days). It is what the study was designed to measure, not a finding.
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 6 May 2025.