Emergency Surgery Versus Colorectal Stents for the Manage... | NCT04449822

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

NCT04449822

Sponsor

Zaza Demetrashvili

Status

Completed

Last Update Posted

May 2, 2022Actual

Enrollment

40Actual

Phase

Not Applicable

Conditions

Colorectal Cancer

Interventions

Emergency surgery
Colonic stenting

Countries

Georgia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 5, 2017Actual

Primary Completion Date

Dec 5, 2021Actual

Completion Date

Mar 5, 2022Actual

First Submitted Date

Jun 24, 2020

First Submission Date that Met QC Criteria

Jun 25, 2020

First Posted Date

Jun 29, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 26, 2022

Last Update Posted Date

May 2, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Zaza Demetrashvili, Associate Professor, Surgery Department, Tbilisi State Medical UniversitySponsor-Investigator

Lead Sponsor

Zaza DemetrashviliOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Emergency surgery	Active Comparator	Surgical decompression with colostomy with or without resection and eventual re-anastomosis.	Procedure: Emergency surgery
Colonic stenting	Active Comparator	The colonic stent placement	Procedure: Colonic stenting

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Emergency surgery	Procedure	Surgical decompression with colostomy with or without resection and eventual re-anastomosis.	Emergency surgery

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The time of clinical relieve of obstruction		24 hours after surgery/procedure

Secondary Outcomes

Measure	Description	Time Frame
Stent related complications	perforation, migration, stent obstruction	time of hospital stay, an average 10 day.
Mortality	30-day mortality

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Zaza Demetrashvili	Tbilisi State Medical University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Tbilisi State Medical University		Tbilisi	Yes	0159	Georgia

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
	Result	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

ID	Term
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site