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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04449822
Enrollment
40
Registered
2020-06-29
Start date
2017-01-05
Completion date
2022-03-05
Last updated
2022-05-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer

Keywords

Hartmann's procedure, colostomy, colonic stenting.

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.

Interventions

PROCEDUREEmergency surgery

Surgical decompression with colostomy with or without resection and eventual re-anastomosis.

PROCEDUREColonic stenting

The colonic stent placement to relieve the colonic obstruction.

Sponsors

Zaza Demetrashvili
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
The time of clinical relieve of obstruction24 hours after surgery/procedure

Secondary

MeasureTime frameDescription
Stent related complicationstime of hospital stay, an average 10 day.perforation, migration, stent obstruction
Mortality30 day after surgery/procedure30-day mortality
Blood losstime of surgery/procedureBlood loss during emergency surgery or during colonic stenting.
operation timeduring surgery/procedureduration of surgery/procedure
Overall complications30 day after surgery/procedurecomplications which developed in postoperative period

Countries

Georgia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026