## Protocol Section
### Identification Module
**NCT ID:** NCT06437691

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

**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

#### Organization Study ID Info
**ID:** StentSurv
#### Organization
**Class:** OTHER
**Full Name:** Kanuni Sultan Suleyman Training and Research Hospital
### Status Module
#### Completion Date
**Date:** 2024-02-20

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31

**Type:** ESTIMATED

**Last Update Submit Date:** 2024-05-25

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2024-02-20

**Type:** ACTUAL

#### Start Date
**Date:** 2016-01-01

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-31
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-25
**Study First Submit QC Date:** 2024-05-25
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Yasir Musa Kesgin, MD

#### Responsible Party

**Investigator Affiliation:** Kanuni Sultan Suleyman Training and Research Hospital

**Investigator Full Name:** Yasir Musa Kesgin, MD

**Investigator Title:** MD

**Type:** SPONSOR_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief 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.

**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

### Conditions Module

**Conditions:**

- Colorectal Cancer

**Keywords:**

- Obstructive Colorectal Cancer, Colorectal Emergencies, Self Expandable Metallic Stents

### Design Module

#### Design Info

**Observational Model:** CASE_CONTROL

**Time Perspective:** RETROSPECTIVE

#### Enrollment Info

**Count:** 65

**Type:** ACTUAL

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Patients underwent emergency surgery directly after coming to emergency department due to left sided obstructive colorectal cancer

**Label:** Group A - Emergency Surgery Group

#### Arm Group 2

**Description:** Left sided obstructive colorectal cancer patients underwent elective surgery following decompression via self-expandable metallic stent placement.

**Intervention Names:**

- Procedure: Self-Expandable Metallic Stent Placement

**Label:** Group B - Stent Group

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Group B - Stent Group

**Name:** Self-Expandable Metallic Stent Placement

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

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

**Measure:** Overall Survival

**Time Frame:** 3 years

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

**Measure:** Disease Free Survival

**Time Frame:** 3 years

#### Secondary Outcomes

**Description:** Death of patient in postoperative first three months

**Measure:** Mortality

**Time Frame:** 90 days

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

**Measure:** Serious complications

**Time Frame:** 90 days

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

**Measure:** Minimally invasive surgery

**Time Frame:** 90 days

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

**Measure:** End colostomy rate

**Time Frame:** 90 days

### Eligibility Module

**Eligibility Criteria:** 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.

**Minimum Age:** 18 Years

**Sampling Method:** PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** Patients come to emergency department and diagnosed as left sided obstructive colorectal cancer

### Contacts Locations Module

#### Overall Officials

**Official 1:**

**Affiliation:** Bakırköy Dr. Sadi Konuk Training and Research Hospital

**Name:** Ahmet Sürek

**Role:** STUDY_CHAIR

### IPD Sharing Statement Module

**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.

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000007414

- Term: Intestinal Neoplasms

- ID: D000005770

- Term: Gastrointestinal Neoplasms

- ID: D000004067

- Term: Digestive System Neoplasms

- ID: D000009371

- Term: Neoplasms by Site

- ID: D000009369

- Term: Neoplasms

- ID: D000004066

- Term: Digestive System Diseases

- ID: D000005767

- Term: Gastrointestinal Diseases

- ID: D000003108

- Term: Colonic Diseases

- ID: D000007410

- Term: Intestinal Diseases

- ID: D000012002

- Term: Rectal Diseases

- ID: D000020969

- Term: Disease Attributes

- ID: D000010335

- Term: Pathologic Processes

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC06

- Name: Digestive System Diseases

### Condition Browse Module - Browse Leaves

- ID: M7796

- Name: Emergencies

- Relevance: HIGH

- As Found: Emergency

- ID: M17890

- Name: Colorectal Neoplasms

- Relevance: HIGH

- As Found: Colorectal Cancer

- ID: M10448

- Name: Intestinal Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M8886

- Name: Gastrointestinal Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M7256

- Name: Digestive System Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M8883

- Name: Gastrointestinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M7255

- Name: Digestive System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M6336

- Name: Colonic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M10444

- Name: Intestinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14844

- Name: Rectal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M22700

- Name: Disease Attributes

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000015179

- Term: Colorectal Neoplasms

- ID: D000004630

- Term: Emergencies

### Misc Info Module

- Version Holder: 2024-05-31
