Colorectal CancerNCT04449822
Emergency Surgery Versus Colorectal Stents for the Management of Malignant Colonic Obstructions
A study testing Emergency surgery and Colonic stenting in people with Colorectal Cancer, run by Zaza Demetrashvili at 1 site in Georgia.
Trial summary
The study evaluates and compares effect of emergency surgery and colonic stents for treatment of malignant colonic obstructions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Emergency surgery and Colonic stenting
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteGeorgia
- Study dates
- 5 Jan 2017to 5 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient with malignant colorectal obstructions.
- Patient's approval to participate in the study.
Who cannot join
- Patient's preference for either treatment method.
- Patient's refusal to participate in the study.
- Patients in the ASA group 4 and 5.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Emergency Surgery Versus Colorectal Stents for the Management of Malignant Colonic Obstructions: a Prospective Cohort Study
The study evaluates and compares effect of emergency surgery and colonic stents for treatment of malignant colonic obstructions.
Read the 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.
- Conditions
- Colorectal Cancer
- Being tested
- Emergency surgery, Colonic stenting
- Keywords
- Hartmann's procedure, colostomy, colonic stenting.
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emergency surgeryProcedure or surgery
Surgical decompression with colostomy with or without resection and eventual re-anastomosis.
Colonic stentingProcedure or surgery
The colonic stent placement to relieve the colonic obstruction.
| Study group | Role | What they receive |
|---|---|---|
| Emergency surgery | Active comparator | Surgical decompression with colostomy with or without resection and eventual re-anastomosis. Receives: Procedure: Emergency surgery |
| Colonic stenting | Active comparator | The colonic stent placement Receives: Procedure: Colonic stenting |
What is being measured
The primary outcome is the main question the study is designed to answer.
The time of clinical relieve of obstruction
Measured: 24 hours after surgery/procedure
Secondary outcomes (5)
Stent related complications
perforation, migration, stent obstruction
Measured: time of hospital stay, an average 10 day.
Mortality
30-day mortality
Measured: 30 day after surgery/procedure
Blood loss
Blood loss during emergency surgery or during colonic stenting.
Measured: time of surgery/procedure
operation time
duration of surgery/procedure
Measured: during surgery/procedure
Overall complications
complications which developed in postoperative period
Measured: 30 day after surgery/procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2020
- Study start5 Jan 2017
- Primary completion5 Dec 2021
- Study completion5 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zaza Demetrashvili
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zaza Demetrashvili, Tbilisi State Medical University
- Investigators
- Zaza Demetrashvili, Principal investigator, Tbilisi State Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04449822
- Sponsor's protocol ID
- 07122017
- Status last verified
- Apr 2022
- First submitted
- 24 Jun 2020
- Last updated
- 2 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Emergency Surgery Versus Colorectal Stents for the Management of Malignant Colonic Obstructions: a Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT04449822
- Acronym / sponsor ID
- 07122017
- Conditions
- Colorectal Cancer
- Keywords
- Hartmann's procedure, colostomy, colonic stenting.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Zaza DemetrashviliUniversity, hospital or other
- Study start
- 5 Jan 2017 (actual)
- Primary completion
- 5 Dec 2021 (actual)
- Study completion
- 5 Mar 2022 (actual)
- First posted
- 29 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Emergency surgery | Active comparator | Procedure: Emergency surgerySurgical decompression with colostomy with or without resection and eventual re-anastomosis. |
| Colonic stenting | Active comparator | Procedure: Colonic stentingThe colonic stent placement |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patient with malignant colorectal obstructions.
- Patient's approval to participate in the study.
Key exclusion criteria (3 listed)
- Patient's preference for either treatment method.
- Patient's refusal to participate in the study.
- Patients in the ASA group 4 and 5.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Emergency surgerySurgical decompression with colostomy with or without resection and eventual re-anastomosis. | Procedure or surgery | Emergency surgery |
| Colonic stentingThe colonic stent placement to relieve the colonic obstruction. | Procedure or surgery | Colonic stenting |
Primary outcome
The time of clinical relieve of obstruction
Time frame: 24 hours after surgery/procedure
5 secondary outcomes
Stent related complications
Time frame: time of hospital stay, an average 10 day.
Mortality
Time frame: 30 day after surgery/procedure
Blood loss
Time frame: time of surgery/procedure
operation time
Time frame: during surgery/procedure
Overall complications
Time frame: 30 day after surgery/procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2022.
- Results publicationMerabishvili 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
Related trials for Colorectal Cancer
Active, not recruitingPhase 1/2
Phase I/II Study of the Anti-Programmed Death Ligand-1 Durvalumab Antibody (MEDI4736) in Combination With Olaparib and/or Cediranib for Advanced Solid Tumors and Advanced or Recurrent Ovarian, Triple Negative Breast, Lung, Prostate and Colorectal Can...
Colorectal Neoplasms, Breast Neoplasms
RecruitingPhase 1
A Study Evaluating the Safety and Efficacy of Targeted Therapies in Subpopulations of Patients With Metastatic Colorectal Cancer (INTRINSIC)
Metastatic Colorectal Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
Not yet recruitingPhase 2
SAMe in Prevention of Oxaliplatin-associated Liver Injury
Colorectal Cancer, Liver Metastases
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zaza Demetrashvili principal investigator
Tbilisi State Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Emergency surgery and Colonic stenting in people with Colorectal Cancer, run by Zaza Demetrashvili at 1 site in Georgia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Georgia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The time of clinical relieve of obstruction (time frame: 24 hours after surgery/procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04449822, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2022; AzTrials last refreshed its copy on 8 Nov 2026.