Colorectal Cancer Clinical Trial
Official title:
Emergency Surgery Versus Colorectal Stents for the Management of Malignant Colonic Obstructions: a Prospective Cohort Study
NCT number | NCT04449822 |
Other study ID # | 07122017 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | January 5, 2017 |
Est. completion date | March 5, 2022 |
Verified date | April 2022 |
Source | Tbilisi State Medical University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The study evaluates and compares effect of emergency surgery and colonic stents for treatment of malignant colonic obstructions.
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. |
Country | Name | City | State |
---|---|---|---|
Georgia | Tbilisi State Medical University | Tbilisi | Yes |
Lead Sponsor | Collaborator |
---|---|
Zaza Demetrashvili |
Georgia,
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
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 |
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