Back to resultsEmergency Surgery Versus Colorectal Stents for the Management of Malignant Colonic Obstructions
Primary Purpose
Colorectal Cancer
Status
Completed
Phase
Not Applicable
Locations
Georgia
Study Type
Interventional
Intervention
Emergency surgery
Colonic stenting
Sponsored by
About this trial
This is an interventional treatment trial for Colorectal Cancer focused on measuring Hartmann's procedure, colostomy, colonic stenting.
Eligibility Criteria
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.
Sites / Locations
- Tbilisi State Medical University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Emergency surgery
Colonic stenting
Arm Description
Surgical decompression with colostomy with or without resection and eventual re-anastomosis.
The colonic stent placement
Outcomes
Primary Outcome Measures
The time of clinical relieve of obstruction
Secondary Outcome Measures
Stent related complications
perforation, migration, stent obstruction
Mortality
30-day mortality
Blood loss
Blood loss during emergency surgery or during colonic stenting.
operation time
duration of surgery/procedure
Overall complications
complications which developed in postoperative period
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04449822
Brief Title
Emergency Surgery Versus Colorectal Stents for the Management of Malignant Colonic Obstructions
Official Title
Emergency Surgery Versus Colorectal Stents for the Management of Malignant Colonic Obstructions: a Prospective Cohort Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
January 5, 2017 (Actual)
Primary Completion Date
December 5, 2021 (Actual)
Study Completion Date
March 5, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Zaza Demetrashvili
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The study evaluates and compares effect of emergency surgery and colonic stents for treatment of malignant colonic obstructions.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
Hartmann's procedure, colostomy, colonic stenting.
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Emergency surgery
Arm Type
Active Comparator
Arm Description
Surgical decompression with colostomy with or without resection and eventual re-anastomosis.
Arm Title
Colonic stenting
Arm Type
Active Comparator
Arm Description
The colonic stent placement
Intervention Type
Procedure
Intervention Name(s)
Emergency surgery
Intervention Description
Surgical decompression with colostomy with or without resection and eventual re-anastomosis.
Intervention Type
Procedure
Intervention Name(s)
Colonic stenting
Intervention Description
The colonic stent placement to relieve the colonic obstruction.
Primary Outcome Measure Information:
Title
The time of clinical relieve of obstruction
Time Frame
24 hours after surgery/procedure
Secondary Outcome Measure Information:
Title
Stent related complications
Description
perforation, migration, stent obstruction
Time Frame
time of hospital stay, an average 10 day.
Title
Mortality
Description
30-day mortality
Time Frame
30 day after surgery/procedure
Title
Blood loss
Description
Blood loss during emergency surgery or during colonic stenting.
Time Frame
time of surgery/procedure
Title
operation time
Description
duration of surgery/procedure
Time Frame
during surgery/procedure
Title
Overall complications
Description
complications which developed in postoperative period
Time Frame
30 day after surgery/procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zaza Demetrashvili
Organizational Affiliation
Tbilisi State Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tbilisi State Medical University
City
Tbilisi
State/Province
Yes
ZIP/Postal Code
0159
Country
Georgia
12. IPD Sharing Statement
Citations:
Citation
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
Results Reference
result
Learn more about this trial
Emergency Surgery Versus Colorectal Stents for the Management of Malignant Colonic Obstructions
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