Management of Obstructive Colon Tumors in Istanbul

NCT05424939 | Unknown DMC

• 1 other identifier: E-10840098-772.02-1214
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 2

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.

Conditions

Colon Cancer; Tumor Obstruction; Emergencies; Quality of Life

Outcome Measures

Primary Outcomes (1)

• Time-to-starting chemotherapy

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

  1 year

Secondary Outcomes (3)

• Mortality

  3 months

• Morbidity

  3 months

• Colorectal cancer-specific quality of life (EORTC QLQ - CR29) at 1 year

  1 year

Interventions

Colectomy PROCEDURE

Colon resection

Stoma procedures PROCEDURE

Any type of colostomy or ileostomy with or without bowel resection

By-pass/laparotomy/laparoscopy/biopsy PROCEDURE

Any palliative surgery without bowel resection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Istanbul Medipol University Hospital: lead

Study Sites (2)

Medipol University Bahcelievler Hospital

Istanbul, 34196, Turkey (Türkiye)

RECRUITING

Medipol Mega Hospital

Istanbul, 34214, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Colonic Neoplasms; Emergencies

Interventions

Colectomy

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Surgical Procedures, Colorectal; Digestive System Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Osman Civil, MD

  Medipol University

  STUDY DIRECTOR

Central Study Contacts

Naciye Cigdem Arslan, MD

CONTACT

+90 531 389 09 75; cigdemarslan@hotmail.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2022
• First Posted: June 21, 2022
• Study Start: June 1, 2022
• Primary Completion: May 31, 2024
• Study Completion: May 31, 2024
• Last Updated: June 21, 2022

Record last verified: 2022-06

Locations

TU (2)