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NCT05424939 Clinical Trial

Management of Obstructive Colon Tumors in Istanbul

Quality of Life Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05424939
Other study ID # E-10840098-772.02-1214
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date June 1, 2022
Est. completion date May 31, 2024

Study information
Verified date June 2022
Source Istanbul Medipol University Hospital
Contact Naciye Cigdem Arslan, MD
Phone +90 531 389 09 75
Email cigdemarslan@hotmail.it
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 500
Est. completion date May 31, 2024
Est. primary completion date May 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Colectomy
Colon resection
• Stoma procedures
Any type of colostomy or ileostomy with or without bowel resection
• By-pass/laparotomy/laparoscopy/biopsy
Any palliative surgery without bowel resection

Locations
Country Name City State
Turkey Medipol Mega Hospital Istanbul
Turkey Medipol University Bahcelievler Hospital Istanbul

Sponsors (1)
Lead Sponsor Collaborator
Istanbul Medipol University Hospital

Country where clinical trial is conducted

Turkey, 

Outcome
Type Measure Description Time frame Safety issue
Primary Time-to-starting chemotherapy Surgical procedures will be compared in terms of days-to-first chemotherapy 1 year
Secondary Mortality 90-day mortality 3 months
Secondary Morbidity 90-day morbidity 3 months
Secondary 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
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