Management of Obstructive Colon Tumors in Istanbul

• Sponsor: Istanbul Medipol University Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05424939
• Collaborator: (none)
• Enrollment: 500
• Locations: 2
• Anticipated Duration (Months): 24
• Patients Per Site: 250
• Patients Per Site Per Month: 10.4

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Colon Cancer; Tumor Obstruction; Emergencies; Quality of Life	Procedure: Colectomy; Procedure: Stoma procedures; Procedure: By-pass/laparotomy/laparoscopy/biopsy

Study Design

• Study Type: Observational
• Anticipated Enrollment: 500 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Management of Obstructive Colon Tumors in Istanbul: Multicenter Prospective Observational Cohort
• Actual Study Start Date: Jun 1, 2022
• Anticipated Primary Completion Date: May 31, 2024
• Anticipated Study Completion Date: May 31, 2024

Outcome Measures

Primary Outcome Measures

1. Time-to-starting chemotherapy [1 year]

   Surgical procedures will be compared in terms of days-to-first chemotherapy

Secondary Outcome Measures

1. Mortality [3 months]

   90-day mortality

2. Morbidity [3 months]

   90-day morbidity

3. Colorectal cancer-specific quality of life (EORTC QLQ - CR29) at 1 year [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Medipol University Bahcelievler Hospital	Istanbul		Turkey	34196
2	Medipol Mega Hospital	Istanbul		Turkey	34214

Sponsors and Collaborators

• Istanbul Medipol University Hospital

Investigators

• Study Director: Osman Civil, MD, Medipol University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Istanbul Medipol University Hospital
• ClinicalTrials.gov Identifier: NCT05424939
• Other Study ID Numbers: E-10840098-772.02-1214
• First Posted: Jun 21, 2022
• Last Update Posted: Jun 21, 2022
• Last Verified: Jun 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Emergencies

Study Results

No Results Posted as of Jun 21, 2022