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

Not Applicable
Completed
Conditions
Colorectal Cancer
Registration Number
NCT04449822
Lead Sponsor
Zaza Demetrashvili
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
40
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 & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
The time of clinical relieve of obstruction24 hours after surgery/procedure
Secondary Outcome Measures
NameTimeMethod
operation timeduring surgery/procedure

duration of surgery/procedure

Stent related complicationstime of hospital stay, an average 10 day.

perforation, migration, stent obstruction

Mortality30 day after surgery/procedure

30-day mortality

Overall complications30 day after surgery/procedure

complications which developed in postoperative period

Blood losstime of surgery/procedure

Blood loss during emergency surgery or during colonic stenting.

Trial Locations

Locations (1)

Tbilisi State Medical University

🇬🇪

Tbilisi, Yes, Georgia

Tbilisi State Medical University
🇬🇪Tbilisi, Yes, Georgia

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