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NCT Number: NCT06437691

Effect of Stent Placement on Short Term Survival of Left Sided Obstructive Colorectal Cancers

The aim of this observational study is to determine effect of stent placement on survival results in first three years in a patient who applied to the emergency department with obstruction due to colorectal cancer. Eligible patients divided into two groups. Group A includes patients underwent emergency surgery directly. Patients underwent elective surgery following stent placement as bridge-to-surgery. Patients underwent elective surgery following bridge-to-surgery stent placement were accepted as Group B.

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Key information

Conditions

Colorectal Cancer Bites and Stings Chemically-Induced Disorders Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Poisoning Rectal Diseases Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

Patients who applied to emergency department of a single tertiary referral center between January 2016 and December 2020 and diagnosed as left sided obstructive colorectal cancer were included in this retrospective study. 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:

  • Who underwent emergency surgery due to unsuccessful stent application intervention or stent-related complications developed,
  • Those with middle and lower rectum tumors or received neoadjuvant treatment,
  • Perforation,
  • Who underwent subtotal or total colectomy (as a result of colon ischemia in the cecum, microperforation, etc.),
  • Recurrent disease patients
  • Patients have metastasis

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All patients were equal or older than 18 years and histopathologically found to have primary colorectal malignant neoplasms and diagnosed as left sided (descending colon, sigmoid colon and upper rectum) obstructive colorectal cancer were included

Exclusion criteria

  • Who underwent emergency surgery due to unsuccessful stent placement intervention
  • Who underwent emergency surgery due to stent-related complications
  • Those with middle and lower rectum tumors
  • Those received neoadjuvant treatment,
  • Patients have perforation,
  • Who underwent subtotal or total colectomy (as a result of colon ischemia in the cecum, microperforation, etc.),
  • Who has a recurrent disease or metastasis.

Treatment and study plan

Self-Expandable Metallic Stent Placement

Procedure

Primary outcomes

  1. Overall Survival

    Time frame: 3 years

    The survival time of patient after being diagnosed as colorectal cancer after coming to emergency department

  2. Disease Free Survival

    Time frame: 3 years

    The local or systemic recurrence free time period of patient after being diagnosed as colorectal cancer after coming to emergency department

Secondary outcomes

  1. Mortality

    Time frame: 90 days

    Death of patient in postoperative first three months

  2. Serious complications

    Time frame: 90 days

    Postoperative complications of patients that have a Clavien-Dindo Score greater than or equal to 3

  3. Minimally invasive surgery

    Time frame: 90 days

    Patients that found a chance for fully minimally invasive surgery for resection of colorectal cancer

  4. End colostomy rate

    Time frame: 90 days

    Patients that have a end colostomy at the end of surgical resection of colorectal cancer

Sponsors and collaborators

Lead sponsor

Yasir Musa Kesgin, MD

Other

Registry information

Official study title

Effect of Stent Placement on Short Term Survival of Left Sided Obstructive Colorectal Cancers. Comparison of Bridge-To-Surgery Versus Emergency Surgery Approaches

Important dates

Study start
2016
Primary completion
2024
Study completion
2024
First posted
May 31, 2024
Registry last updated
Aug 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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