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

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

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

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer
• Intervention / Treatment: Procedure: Emergency surgery; Procedure: Colonic stenting

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Georgia
  • Yes
    • Tbilisi, Yes, Georgia, 0159
      • Tbilisi State Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Emergency surgery; Surgical decompression with colostomy with or without resection and eventual re-anastomosis.	Procedure: Emergency surgery; Surgical decompression with colostomy with or without resection and eventual re-anastomosis.
Active Comparator: Colonic stenting; The colonic stent placement	Procedure: Colonic stenting; The colonic stent placement to relieve the colonic obstruction.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The time of clinical relieve of obstruction	24 hours after surgery/procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stent related complications	perforation, migration, stent obstruction	time of hospital stay, an average 10 day.
Mortality	30-day mortality	30 day after surgery/procedure
Blood loss	Blood loss during emergency surgery or during colonic stenting.	time of surgery/procedure
operation time	duration of surgery/procedure	during surgery/procedure
Overall complications	complications which developed in postoperative period	30 day after surgery/procedure

Collaborators and Investigators

• Sponsor: Zaza Demetrashvili
• Investigators: Principal Investigator: Zaza Demetrashvili, Tbilisi State Medical University

Publications and helpful links

General Publications

• 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: 10.31080/ASMS.2020.05.0863

Study record dates

Study Major Dates

• Study Start (Actual): January 5, 2017
• Primary Completion (Actual): December 5, 2021
• Study Completion (Actual): March 5, 2022

Study Registration Dates

• First Submitted: June 24, 2020
• First Submitted That Met QC Criteria: June 25, 2020
• First Posted (Actual): June 29, 2020

Study Record Updates

• Last Update Posted (Actual): May 2, 2022
• Last Update Submitted That Met QC Criteria: April 26, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Hartmann's procedure, colostomy, colonic stenting.
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Emergencies
• Other Study ID Numbers: 07122017

Drug and device information, study documents

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