Colon CancerNCT05424939
Management of Obstructive Colon Tumors in Istanbul
An observational study of Colon Cancer and Tumor Obstruction, run by Istanbul Medipol University Hospital at 2 sites in Turkey (Türkiye).
Trial summary
The aim of this study is to evaluate the outcome of obstructive colon cancer surgery in terms of days-to-starting adjuvant therapy and quality of life. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colon Cancer, Tumor Obstruction, Emergencies
- What is being tested?
- Colectomy, Stoma procedures and By-pass/laparotomy/laparoscopy/biopsy
- Type of treatment
- Surgery or procedure
- How many people
- 500 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 1 Jun 2022to 31 May 2024
- Phase
- Observational
- 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
Study population: Adults who underwent surgery with a clinical and radiological diagnosis of obstructive colon tumors at any stage will be included in the study.
Who may be able to join
- Acute intestinal obstruction due to colon cancer either preoperatively or intraoperatively detected
- Clinical findings of obstruction (Abdominal distention and pain, nausea or vomiting, and absence of bowel movements) confirmed by abdominal x-ray or CT
Who cannot join
- Benign diseases
- Emergency surgery due to bleeding, perforation and other non-obstructive situations
- Recurrent colon tumors
- Rectal cancer
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites, 2 recruiting
- Recruiting
Medipol University Bahcelievler Hospital
Istanbul, 34196
Osman Civil, MD, +905058334286, dr.ocivil@hotmail.com
Naciye Cigdem Arslan, MD
- Recruiting
Medipol Mega Hospital
Istanbul, 34214
Mustafa Oncel, MD, +905324247750, mustafa.oncel@medipol.edu.tr
Nuri Okkabaz, MD
About this study
Official title: Management of Obstructive Colon Tumors in Istanbul: Multicenter Prospective Observational Cohort
The aim of this study is to evaluate the outcome of obstructive colon cancer surgery in terms of days-to-starting adjuvant therapy and quality of life.
- Conditions
- Colon Cancer, Tumor Obstruction, Emergencies, Quality of Life
- Being tested
- Colectomy, Stoma procedures, By-pass/laparotomy/laparoscopy/biopsy
- Medical subject headings
- Colonic Neoplasms, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ColectomyProcedure or surgery
Colon resection
Stoma proceduresProcedure or surgery
Any type of colostomy or ileostomy with or without bowel resection
By-pass/laparotomy/laparoscopy/biopsyProcedure or surgery
Any palliative surgery without bowel resection
What is being measured
The primary outcome is the main question the study is designed to answer.
Time-to-starting chemotherapy
Surgical procedures will be compared in terms of days-to-first chemotherapy
Measured: 1 year
Secondary outcomes (3)
Mortality
90-day mortality
Measured: 3 months
Morbidity
90-day morbidity
Measured: 3 months
Colorectal cancer-specific quality of life (EORTC QLQ - CR29) at 1 year
The European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire-Colorectal Cancer (EORTC QLQ-CR29) scale will be recorded preoperatively and at 12 months. Surgical procedures will be compared in terms of improvement in EORTC QLQ-CR29 scores.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2022
- Study start1 Jun 2022
- Primary completion31 May 2024 (estimated)
- Study completion31 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Osman Civil, MD, Study director, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05424939
- Sponsor's protocol ID
- E-10840098-772.02-1214
- Status last verified
- Jun 2022
- First submitted
- 11 May 2022
- Last updated
- 21 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Obstructive Colon Tumors in Istanbul: Multicenter Prospective Observational Cohort
- ClinicalTrials.gov ID
- NCT05424939
- Acronym / sponsor ID
- E-10840098-772.02-1214
- Conditions
- Colon Cancer, Tumor Obstruction, Emergencies, Quality of Life
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 31 May 2024 (estimated)
- Study completion
- 31 May 2024 (estimated)
- First posted
- 21 Jun 2022 (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 aim of this study is to evaluate the outcome of obstructive colon cancer surgery in terms of days-to-starting adjuvant therapy and quality of life.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults who underwent surgery with a clinical and radiological diagnosis of obstructive colon tumors at any stage will be included in the study.
Key inclusion criteria (2 listed)
- Acute intestinal obstruction due to colon cancer either preoperatively or intraoperatively detected
- Clinical findings of obstruction (Abdominal distention and pain, nausea or vomiting, and absence of bowel movements) confirmed by abdominal x-ray or CT
Key exclusion criteria (4 listed)
- Benign diseases
- Emergency surgery due to bleeding, perforation and other non-obstructive situations
- Recurrent colon tumors
- Rectal cancer
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 |
|---|---|---|
| ColectomyColon resection | Procedure or surgery | – |
| Stoma proceduresAny type of colostomy or ileostomy with or without bowel resection | Procedure or surgery | – |
| By-pass/laparotomy/laparoscopy/biopsyAny palliative surgery without bowel resection | Procedure or surgery | – |
Primary outcome
Time-to-starting chemotherapy
Time frame: 1 year
Surgical procedures will be compared in terms of days-to-first chemotherapy
3 secondary outcomes
Mortality
Time frame: 3 months
Morbidity
Time frame: 3 months
Colorectal cancer-specific quality of life (EORTC QLQ - CR29) at 1 year
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2022.
- Individual participant dataSharing planned: Undecided
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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.
Osman Civil, MD study director
Medipol University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colon Cancer and Tumor Obstruction, run by Istanbul Medipol University Hospital at 2 sites in Turkey (Türkiye).
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 4 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: status not confirmed, as of the sponsor's last update on 21 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Naciye Cigdem Arslan, MD (+90 531 389 09 75, cigdemarslan@hotmail.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time-to-starting chemotherapy (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Jun 2022.