Management of Obstructive Colon Tumors in Istanbul

Management of Obstructive Colon Tumors in Istanbul: Multicenter Prospective Observational Cohort

The aim of this study is to evaluate the outcome of obstructive colon cancer surgery in terms of days-to-starting adjuvant therapy and quality of life.

Study Overview

• Status: Recruiting
• Conditions: Quality of Life; Emergencies; Colon Cancer; Tumor Obstruction
• Intervention / Treatment: Procedure: Colectomy; Procedure: Stoma procedures; Procedure: By-pass/laparotomy/laparoscopy/biopsy

• Study Type: Observational
• Enrollment (Anticipated): 500

Contacts and Locations

• Study Contact: Name: Naciye Cigdem Arslan, MD; Phone Number: +90 531 389 09 75; Email: cigdemarslan@hotmail.it

Study Locations

• Turkey
  • Istanbul, Turkey, 34196
    • Recruiting
    • Medipol University Bahcelievler Hospital
    • Contact: Osman Civil, MD; Phone Number: +905058334286; Email: dr.ocivil@hotmail.com
    • Sub-Investigator: Naciye Cigdem Arslan, MD
  • Istanbul, Turkey, 34214
    • Recruiting
    • Medipol Mega Hospital
    • Contact: Mustafa Oncel, MD; Phone Number: +905324247750; Email: mustafa.oncel@medipol.edu.tr
    • Sub-Investigator: Nuri Okkabaz, MD
    • Sub-Investigator: Mustafa Haksal, MD
    • Principal Investigator: Mustafa Oncel, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adults who underwent surgery with a clinical and radiological diagnosis of obstructive colon tumors at any stage will be included in the study.

Description

Inclusion Criteria:

• Acute intestinal obstruction due to colon cancer either preoperatively or intraoperatively detected
• Clinical findings of obstruction (Abdominal distention and pain, nausea or vomiting, and absence of bowel movements) confirmed by abdominal x-ray or CT

Exclusion Criteria:

• Benign diseases
• Emergency surgery due to bleeding, perforation and other non-obstructive situations
• Recurrent colon tumors
• Rectal cancer

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time-to-starting chemotherapy	Surgical procedures will be compared in terms of days-to-first chemotherapy	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality	90-day mortality	3 months
Morbidity	90-day morbidity	3 months
Colorectal cancer-specific quality of life (EORTC QLQ - CR29) at 1 year	The European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire-Colorectal Cancer (EORTC QLQ-CR29) scale will be recorded preoperatively and at 12 months. Surgical procedures will be compared in terms of improvement in EORTC QLQ-CR29 scores.	1 year

Collaborators and Investigators

• Sponsor: Istanbul Medipol University Hospital
• Investigators: Study Director: Osman Civil, MD, Medipol University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2022
• Primary Completion (Anticipated): May 31, 2024
• Study Completion (Anticipated): May 31, 2024

Study Registration Dates

• First Submitted: May 11, 2022
• First Submitted That Met QC Criteria: June 17, 2022
• First Posted (Actual): June 21, 2022

Study Record Updates

• Last Update Posted (Actual): June 21, 2022
• Last Update Submitted That Met QC Criteria: June 17, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Emergencies
• Other Study ID Numbers: E-10840098-772.02-1214

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No