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

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

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.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer
• Intervention / Treatment: Procedure: Self-Expandable Metallic Stent Placement

Detailed 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

• Study Type: Observational
• Enrollment (Actual): 65

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients come to emergency department and diagnosed as left sided obstructive colorectal cancer

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group A - Emergency Surgery Group; Patients underwent emergency surgery directly after coming to emergency department due to left sided obstructive colorectal cancer
Group B - Stent Group; Left sided obstructive colorectal cancer patients underwent elective surgery following decompression via self-expandable metallic stent placement.	Procedure: Self-Expandable Metallic Stent Placement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival	The survival time of patient after being diagnosed as colorectal cancer after coming to emergency department	3 years
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality	Death of patient in postoperative first three months	90 days
Serious complications	Postoperative complications of patients that have a Clavien-Dindo Score greater than or equal to 3	90 days
Minimally invasive surgery	Patients that found a chance for fully minimally invasive surgery for resection of colorectal cancer	90 days
End colostomy rate	Patients that have a end colostomy at the end of surgical resection of colorectal cancer	90 days

Collaborators and Investigators

• Sponsor: Yasir Musa Kesgin, MD
• Investigators: Study Chair: Ahmet Sürek, Bakırköy Dr. Sadi Konuk Training and Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2016
• Primary Completion (Actual): February 20, 2024
• Study Completion (Actual): February 20, 2024

Study Registration Dates

• First Submitted: May 25, 2024
• First Submitted That Met QC Criteria: May 25, 2024
• First Posted (Actual): May 31, 2024

Study Record Updates

• Last Update Posted (Actual): August 20, 2024
• Last Update Submitted That Met QC Criteria: August 19, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Obstruction, Bridge To Surgery
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: StentSurv

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The datasets generated and analysed during the current study are not publicly available due to institutional policies but are available from the contact person on reasonable request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No