Colon CancerCOLRABINCT05546892
Short-term Outcomes of Full Bowel Preparation (MBP+OA) for Colon Cancer Resections Versus no Bowel Preparation
A study testing Full bowel preparation prior to colon resection for cancer and No bowel preparation in people with Colon Cancer, run by N.N. Petrov National Medical Research Center of Oncology at 1 site in Russia.
Trial summary
The purpose of the study is to determine if short-term outcomes of colon resections after full bowel preparation (mechanical bowel preparation plus oral antibiotics) are superior to colon resections with no bowel preparation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colon Cancer
- What is being tested?
- Full bowel preparation prior to colon resection for cancer and No bowel preparation
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 586 participants
- Where
- 1 siteRussia
- Study dates
- 10 Feb 2023to Sep 2025
- 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
- histologically confirmed adenocarcinoma of the colon (caecum, ascending, transverse, descending, sigmoid)
- clinical stage T1-4aN0-2M0-1 (distant metastases must be resectable)
- indications for surgical colonic resection
- ECOG status 0-2
- At least 18 years of age
- Written informed consent
Who cannot join
- Medical or psychiatric conditions that compromise the patient's ability to give informed consent or comply with the study protocol
- Pregnancy or breast feeding
- Medical contraindications for surgical treatment
- Any use of antibiotics 30 days prior to inclusion
- Functioning stoma
- Contraindications for use of MBP or OA drugs or their components
Show all 10Show fewer
- Indications for mandatory MBP (planned intraoperative colonoscopy etc)
- Indications for obstructive resection
- Acute bowel obstruction, bleeding or perforation
- Other malignancies not in remission
Trial locations and contacts
1 site in 1 country.
Russia1 site, 1 recruiting
- Recruiting
N.N. Petrov National Medical Research Center of Oncology
Saint Petersburg, 197758
Aleksei Petrov, +79214117866, alexpetrov@doctor.com
Aleksei Karachun
About this study
Official title: Short-term Outcomes of Full Bowel Preparation (MBP+OA) for Colon Resections for Cancer Versus no Bowel Preparation
The purpose of the study is to determine if short-term outcomes of colon resections after full bowel preparation (mechanical bowel preparation plus oral antibiotics) are superior to colon resections with no bowel preparation.
Read the detailed description
The design involves random allocation of eligible patients to full bowel preparation or no bowel preparation in 1:1 ratio. After that colon resection is performed in both groups.
Short-term outcomes are assessed in 30 day period after surgery. This is a superiority trial evaluating statistical superiority. Rate of anastomotic leak is anticipated to decrease from 8% (data from local registry) to 3%. For power of 80% enrolment of 586 patients is required.
The intent-to-treat principle is used for the data analysis.
- Conditions
- Colon Cancer
- Being tested
- Full bowel preparation prior to colon resection for cancer, No bowel preparation
- Keywords
- colon cancer, MBP, bowel preparation, oral antibiotics
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Full bowel preparation prior to colon resection for cancerProcedure or surgery
Mechanical bowel preparation and oral antibiotics
No bowel preparationProcedure or surgery
Omission of any bowel preparation
| Study group | Role | What they receive |
|---|---|---|
| Full bowel preparation (MBP+OA) | Experimental | Rifaximin 400 mg twice daily for three days prior to surgery
Day prior to surgery:
17.00 - 18.00 Macrogol-3350 - 100 g Natrium sulfate - 7,5 g Natrium chloride - 2,691 g Potassium chloride - 1,015 g Ascorbic acid - 4,7 g Natrii ascorbate - 5,9 g Clear fluids - 1000 ml
18.00 - 19.00 Clear fluids 500 ml
19.00 - 20.00 Macrogol-3350 - 100 g Natrium sulfate - 7,5 g Natrium chloride - 2,691 g Potassium chloride - 1,015 g Ascorbic acid - 4,7 g Natrii ascorbate - 5,9 g Clear fluids - 1000 ml
20.00 - 21.00 Clear fluids 500 ml Receives: Procedure: Full bowel preparation prior to colon resection for cancer |
| No bowel preparation | Active comparator | No bowel preparation (enema of not more then 500 ml is allowed prior or during surgery) Receives: Procedure: No bowel preparation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anastomotic leak rate
Rate of anastomotic leak in patients after colon resections
Measured: 30 days
Secondary outcomes (7)
Surgical site infection (SSI) rate
Rate of Surgical site infection
Measured: 30 days
Intraabdominal and or pelvic abscess rate
Rate of intraabdominal and or pelvic abscess
Measured: 30 days
Overall morbidity
Rate of patients with any complications after surgery
Measured: 30 days
Rate of intraoperative complications
Rate of patients with intraoperative complications
Measured: Duration of surgical procedure
Surgery duration in minutes
Time of surgical procedure
Measured: Duration of surgical procedure
Quality of bowel preparation assessed by surgeon
Assessment of bowel preparation quality by surgeon (qualitative scale)
Measured: Day of surgical procedure
Bowel preparation compliance
Rate of patients in experimental arm undergoing complete bowel preparation according to protocol
Measured: Day of surgical procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2022
- Study start10 Feb 2023
- Primary completionSep 2025 (estimated)
- Study completionSep 2025 (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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 586 participants (estimated)
Sponsor and investigators
- Lead sponsor
- N.N. Petrov National Medical Research Center of Oncology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aleksei Karachun, Study chair, N.N. Petrov National Medical Research Center of Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05546892
- Sponsor's protocol ID
- COL-2
- Acronym
- COLRABI
- Status last verified
- Mar 2023
- First submitted
- 15 Sep 2022
- Last updated
- 29 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We are not planning to share individual participant data
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-term Outcomes of Full Bowel Preparation (MBP+OA) for Colon Resections for Cancer Versus no Bowel Preparation
- ClinicalTrials.gov ID
- NCT05546892
- Acronym / sponsor ID
- COLRABI / COL-2
- Conditions
- Colon Cancer
- Keywords
- colon cancer, MBP, bowel preparation, oral antibiotics
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 586 participants (estimated)
- Lead sponsor
- N.N. Petrov National Medical Research Center of OncologyUniversity, hospital or other
- Study start
- 10 Feb 2023 (actual)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 21 Sep 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 purpose of the study is to determine if short-term outcomes of colon resections after full bowel preparation (mechanical bowel preparation plus oral antibiotics) are superior to colon resections with no bowel preparation.
Detailed description
The design involves random allocation of eligible patients to full bowel preparation or no bowel preparation in 1:1 ratio. After that colon resection is performed in both groups.
Short-term outcomes are assessed in 30 day period after surgery. This is a superiority trial evaluating statistical superiority. Rate of anastomotic leak is anticipated to decrease from 8% (data from local registry) to 3%. For power of 80% enrolment of 586 patients is required.
The intent-to-treat principle is used for the data analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Full bowel preparation (MBP+OA) | Experimental | Procedure: Full bowel preparation prior to colon resection for cancerRifaximin 400 mg twice daily for three days prior to surgery Day prior to surgery: 17.00 - 18.00 Macrogol-3350 - 100 g Natrium sulfate - 7,5 g Natrium chloride - 2,691 g Potassium chloride - 1,015 g Ascorbic acid - 4,7 g Natrii ascorbate - 5,9 g Clear fluids - 1000 ml 18.00 - 19.00 Clear fluids 500 ml 19.00 - 20.00 Macrogol-3350 - 100 g Natrium sulfate - 7,5 g Natrium chloride - 2,691 g Potassium chloride - 1,015 g Ascorbic acid - 4,7 g Natrii ascorbate - 5,9 g Clear fluids - 1000 ml 20.00 - 21.00 Clear fluids 500 ml |
| No bowel preparation | Active comparator | Procedure: No bowel preparationNo bowel preparation (enema of not more then 500 ml is allowed prior or during surgery) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- histologically confirmed adenocarcinoma of the colon (caecum, ascending, transverse, descending, sigmoid)
- clinical stage T1-4aN0-2M0-1 (distant metastases must be resectable)
- indications for surgical colonic resection
- ECOG status 0-2
- At least 18 years of age
Key exclusion criteria (10 listed)
- Medical or psychiatric conditions that compromise the patient's ability to give informed consent or comply with the study protocol
- Pregnancy or breast feeding
- Medical contraindications for surgical treatment
- Any use of antibiotics 30 days prior to inclusion
- Functioning stoma
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 |
|---|---|---|
| Full bowel preparation prior to colon resection for cancerMechanical bowel preparation and oral antibiotics | Procedure or surgery | Full bowel preparation (MBP+OA) |
| No bowel preparationOmission of any bowel preparation | Procedure or surgery | No bowel preparation |
Primary outcome
Anastomotic leak rate
Time frame: 30 days
Rate of anastomotic leak in patients after colon resections
7 secondary outcomes
Surgical site infection (SSI) rate
Time frame: 30 days
Intraabdominal and or pelvic abscess rate
Time frame: 30 days
Overall morbidity
Time frame: 30 days
Rate of intraoperative complications
Time frame: Duration of surgical procedure
Surgery duration in minutes
Time frame: Duration of surgical procedure
Quality of bowel preparation assessed by surgeon
Time frame: Day of surgical procedure
Bowel preparation compliance
Time frame: Day of surgical procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2023.
- Individual participant dataSharing planned: No. We are not planning to share individual participant data
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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.
Aleksei Karachun study chair
N.N. Petrov National Medical Research Center of Oncology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Full bowel preparation prior to colon resection for cancer and No bowel preparation in people with Colon Cancer, run by N.N. Petrov National Medical Research Center of Oncology at 1 site in Russia.
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 6 inclusion and 10 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 29 Mar 2023. 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 Russia. 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 Aleksei Karachun (+79219462123, dr.a.karachun@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anastomotic leak rate (time frame: 30 days). 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 29 Mar 2023.