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

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06437691
• Other study ID #: StentSurv
• Status: Completed
• Start date: January 1, 2016
• Est. completion date: February 20, 2024

Study information

• Verified date: May 2024
• Source: Kanuni Sultan Suleyman Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: February 20, 2024
• Est. primary completion date: February 20, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms
• Emergencies

Intervention

Procedure:
• Self-Expandable Metallic Stent Placement

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Yasir Musa Kesgin, MD

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival	The survival time of patient after being diagnosed as colorectal cancer after coming to emergency department	3 years
Primary	Disease Free Survival	The local or systemic recurrence free time period of patient after being diagnosed as colorectal cancer after coming to emergency department	3 years
Secondary	Mortality	Death of patient in postoperative first three months	90 days
Secondary	Serious complications	Postoperative complications of patients that have a Clavien-Dindo Score greater than or equal to 3	90 days
Secondary	Minimally invasive surgery	Patients that found a chance for fully minimally invasive surgery for resection of colorectal cancer	90 days
Secondary	End colostomy rate	Patients that have a end colostomy at the end of surgical resection of colorectal cancer	90 days