Risk Factors Associated With Morbidity and Mortality in Emergency Colorectal Cancer Resections

Sponsor
Bakirkoy Dr. Sadi Konuk Research and Training Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT06074432
Collaborator
(none)
191
1
1.2
161.5

Study Details

Study Description

Brief Summary

Study is designed to investigate the risk factors associated with morbidity and mortality in patients who underwent emergency resection because of colorectal cancer in general surgery clinic of a tertiary referral hospital.

Condition or Disease Intervention/Treatment Phase
  • Other: Emergency Colorectal Resection

Detailed Description

Patients who underwent emergency colorectal resection in a single tertiary referral center between January 2019 and December 2022 were planned to include. All patients were equal or older than 18 years and histopathologically found to have primary colorectal malignant neoplasms.

Patients were excluded from the analysis if they met any of the following criteria: patients underwent surgery without resection, patients operated with a different indication from primary colorectal cancer such as diverticulitis, ischemia, inflammatory bowel diseases or metastases of another malignancy. Patients with insufficient clinical data were also excluded.

Surgical procedures were performed by general surgeons and only some of them had a subspecialisation in colorectal surgery.

Factors such as age, sex, body mass index (BMI), ASA score, Charlson comorbidity index, smoking status and comorbidity histories, existence of perioperative blood transfusions, duration of surgery, length of hospital stay, tumor side and characteristics, presence of perforation and ascites of the cases were noted. Patients were divided into two subgroups in terms of ASA scores. ASA I and II patients were the first subgroup and ASA III and IV were the other subgroup. A tumor located distal to the midpoint of the transverse colon was accepted as left sided and the others as proximal right sided.

Nutritional risk screening (NRS 2002) scores of the patients were also included in the analyzes. NRS 2002 scores were recorded at hospital admission. Patients were divided into two subgroups as being at nutritional risk (score 3 or more) or not (score less than 3) according to the total score recorded. For the presence of morbidity, a Clavien-Dindo score of 3 and more complications were taken as basis. Mortality was defined as the death within 90 days of operation.

Risk factors for both morbidity and mortality were first evaluated using univariate analyzes. Factors detected as significantly related to morbidity and mortality in appropriate univariate analyzes were included in multivariate analyzes with logistic regression. Multivariate analyzes done for both morbidity and mortality. The effects of risk factors on morbidity and mortality were expressed as the relative risk (odds ratio) with their 95% confidence intervals. Statistical significance level was set at 0.05

Study Design

Study Type:
Observational
Actual Enrollment :
191 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Risk Factors Associated With Morbidity and Mortality in Emergency Colorectal Cancer Resections
Actual Study Start Date :
Jul 25, 2023
Actual Primary Completion Date :
Aug 10, 2023
Actual Study Completion Date :
Aug 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Emergency Colorectal Cancer Resection

Patients that underwent emergent resection because of histopathologically confirmed colorectal carcinoma

Other: Emergency Colorectal Resection
Patients underwent resection due to colorectal carcinoma in emergency surgery

Outcome Measures

Primary Outcome Measures

  1. Morbidity [Until postoperative 90 days]

    Patients developed a major complication that has a Clavien-Dindo Score ≥3

  2. Mortality [Until postoperative 90 days]

    Patients died in the postoperative period within 90 days

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Patients who underwent emergency colorectal resection between January,1 2019 and December,31 2022 were included. All patients were equal or older than 18 years and histopathologically found to have primary colorectal malignant neoplasms
Exclusion Criteria:
  • Patients operated with a different indication from primary colorectal cancer such as diverticulitis, ischemia, inflammatory bowel diseases or metastases of another malignancy

  • Patients with insufficient clinical data were also excluded.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Bakırkoy Dr.Sadi Konuk Training and Research Hospital Istanbul Turkey

Sponsors and Collaborators

  • Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Investigators

  • Study Chair: Mehmet Karabulut, University of Health Sciences, Bakirkoy Dr.Sadi Konuk Training and Research

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Turgut Donmez, Associate Professor, Bakirkoy Dr. Sadi Konuk Research and Training Hospital
ClinicalTrials.gov Identifier:
NCT06074432
Other Study ID Numbers:
  • Emer. CRC Mort Risk Factors
First Posted:
Oct 10, 2023
Last Update Posted:
Oct 10, 2023
Last Verified:
Oct 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Turgut Donmez, Associate Professor, Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 10, 2023