Emergency Surgery Versus Colorectal Stents for the Management of Malignant Colonic Obstructions

Colorectal Cancer Clinical Trial

Official title:

Emergency Surgery Versus Colorectal Stents for the Management of Malignant Colonic Obstructions: a Prospective Cohort Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04449822
• Other study ID #: 07122017
• Status: Completed
• Phase: N/A
• Start date: January 5, 2017
• Est. completion date: March 5, 2022

Study information

• Verified date: April 2022
• Source: Tbilisi State Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study evaluates and compares effect of emergency surgery and colonic stents for treatment of malignant colonic obstructions.

Description:

Acute colonic obstruction is one of the common clinical presentations of colorectal cancer. Surgical decompression with colostomy with or without resection and eventual re-anastomosis is the treatment of choice; however, emergency surgery is associated with higher morbidity and mortality. The colonic stent insertion effectively decompressed the obstructed colon and avoid needs of emergency surgery. This method is a palliation and bridge to surgery. Colonic stents allowed surgery to be performed electively.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 5, 2022
• Est. primary completion date: December 5, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient with malignant colorectal obstructions.
• Patient's approval to participate in the study.

Exclusion Criteria:

• Patient's preference for either treatment method.
• Patient's refusal to participate in the study.
• Patients in the ASA group 4 and 5.

Related Conditions & MeSH terms

• Colorectal Cancer
• Emergencies

Intervention

Procedure:
• Emergency surgery
Surgical decompression with colostomy with or without resection and eventual re-anastomosis.
• Colonic stenting
The colonic stent placement to relieve the colonic obstruction.

Locations

Country	Name	City	State
Georgia	Tbilisi State Medical University	Tbilisi	Yes

Sponsors (1)

Lead Sponsor	Collaborator
Zaza Demetrashvili

Country where clinical trial is conducted

Georgia, 

References & Publications (1)

Merabishvili G, Agdgomelashvili I, Mosidze B, Demetrashvili Z. Emergency surgery versus colorectal stenting for the management of left-sided malignant colon obstructions:A prospective cohort study. Acta Scientific Medical Sciences 2021, 5(4):18-23. doi: 1

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The time of clinical relieve of obstruction		24 hours after surgery/procedure
Secondary	Stent related complications	perforation, migration, stent obstruction	time of hospital stay, an average 10 day.
Secondary	Mortality	30-day mortality	30 day after surgery/procedure
Secondary	Blood loss	Blood loss during emergency surgery or during colonic stenting.	time of surgery/procedure
Secondary	operation time	duration of surgery/procedure	during surgery/procedure
Secondary	Overall complications	complications which developed in postoperative period	30 day after surgery/procedure