Emergency Surgery Versus Colorectal Stents for the Management of Malignant Colonic Obstructions
1 other identifier
interventional
40
1 country
1
Brief Summary
The study evaluates and compares effect of emergency surgery and colonic stents for treatment of malignant colonic obstructions.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable colorectal-cancer
Started Jan 2017
Longer than P75 for not_applicable colorectal-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 5, 2017
CompletedFirst Submitted
Initial submission to the registry
June 24, 2020
CompletedFirst Posted
Study publicly available on registry
June 29, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 5, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
March 5, 2022
CompletedMay 2, 2022
April 1, 2022
4.9 years
June 24, 2020
April 26, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The time of clinical relieve of obstruction
24 hours after surgery/procedure
Secondary Outcomes (5)
Stent related complications
time of hospital stay, an average 10 day.
Mortality
30 day after surgery/procedure
Blood loss
time of surgery/procedure
operation time
during surgery/procedure
Overall complications
30 day after surgery/procedure
Study Arms (2)
Emergency surgery
ACTIVE COMPARATORSurgical decompression with colostomy with or without resection and eventual re-anastomosis.
Colonic stenting
ACTIVE COMPARATORThe colonic stent placement
Interventions
Surgical decompression with colostomy with or without resection and eventual re-anastomosis.
The colonic stent placement to relieve the colonic obstruction.
Eligibility Criteria
You may qualify if:
- Patient with malignant colorectal obstructions.
- Patient's approval to participate in the study.
You may not qualify if:
- Patient's preference for either treatment method.
- Patient's refusal to participate in the study.
- Patients in the ASA group 4 and 5.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Tbilisi State Medical University
Tbilisi, Yes, 0159, Georgia
Related 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: 10.31080/ASMS.2020.05.0863
RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Zaza Demetrashvili
Tbilisi State Medical University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Associate Professor, Surgery Department
Study Record Dates
First Submitted
June 24, 2020
First Posted
June 29, 2020
Study Start
January 5, 2017
Primary Completion
December 5, 2021
Study Completion
March 5, 2022
Last Updated
May 2, 2022
Record last verified: 2022-04