Rectal CancerREPCANCT04592289
Short-term Outcomes of Full Bowel Preparation (MBP+OA) for Rectal Resections for Cancer Versus MBP Alone
A study testing Full bowel preparation and Mechanical bowel preparation only in people with Rectal Cancer, run by N.N. Petrov National Medical Research Center of Oncology at 7 sites in Russia.
Trial summary
The purpose of the study is to determine if short-term outcomes of rectal resections after full bowel preparation (mechanical bowel preparation plus oral antibiotics) are superior to rectal resections with only mechanical bowel preparation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- Full bowel preparation and Mechanical bowel preparation only
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 622 participants
- Where
- 7 sitesRussia
- Study dates
- 30 Oct 2020to Aug 2024
- 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 rectum or rectosigmoid junction
- clinical stage T1-4aN0-2M0-1 (distant metastases must be resectable)
- indications for surgical rectal 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 9Show fewer
- Indications for obstructive resection or abdominoperineal excision
- Acute bowel obstruction, bleeding or perforation
- Other malignancies not in remission
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Russia7 sites, 7 recruiting
- Recruiting
GBUZ Moscow Clinical Scientific Center named after Loginov MHD
Moscow
Georgy Saakyan, +79629532211, G.saakian@mknc.ru
Oleg Knyazev
- Recruiting
I.M. Sechenov First Moscow State Medical University, Clinic of Oncology, Radiotherapy and Reconstructive Surgery
Moscow
Liliya Polishchuk, +79166349069, polishchuk13@gmail.com
Fedor Vetshev
- Recruiting
Lomonosov Moscow State University Medical Research and Educational Center
Moscow
Tatiana Garmanova, +79773429249, Tatianagarmanova@gmail.com
Mikhail Agapov
- Recruiting
Ryazan State Clinical Hospital
Ryazan
Ivan Ignatov, +79065440152, ignatov.mac93@mail.ru
Ivan Ignatov
- Recruiting
Scientific-Research institute of Oncology named after N.N. Petrov
Saint Petersburg, 197758
Aleksei Petrov, +79214117866, alexpetrov@doctor.com
Aleksei Karachun
- Recruiting
Tomsk Regional Oncology Hospital
Tomsk
Evgeniy Drozdov, +79234186405, e.s.drozdov@tomonco.ru
Evgeniy Drozdov
- Recruiting
Volgograd State Medical University, Ministry of Health of Russia
Volgograd
Mikhail Postolov, +79093845833, 1postolov1@mail.ru
Victoriya Zhavoronkova
About this study
The purpose of the study is to determine if short-term outcomes of rectal resections after full bowel preparation (mechanical bowel preparation plus oral antibiotics) are superior to rectal resections with only mechanical bowel preparation.
Read the detailed description
The design involves random allocation of eligible patients to full bowel preparation or only mechanical bowel preparation in 1:1 ratio. After that rectal 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 surgical site infection is anticipated to decrease from 12% (data from local registry) to 6%. For power of 80% enrolment of 622 patients is required.
The intent-to-treat principle is used for the data analysis.
- Conditions
- Rectal Cancer
- Being tested
- Full bowel preparation, Mechanical bowel preparation only
- Keywords
- rectal cancer, bowel preparation, MBP, Oral antibiotics
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Full bowel preparationProcedure or surgery
MBP+OA
Mechanical bowel preparation onlyProcedure or surgery
MBP
| 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 Sodium sulfate - 7,5 g Sodium chloride - 2,691 g Potassium chloride - 1,015 g Ascorbic acid - 4,7 g Sodium ascorbate - 5,9 g Clear fluids - 1000 ml
18.00 - 19.00 Clear fluids 500 ml
19.00 - 20.00 17.00 - 18.00 Macrogol-3350 - 100 g Sodium sulfate - 7,5 g Sodium chloride - 2,691 g Potassium chloride - 1,015 g Ascorbic acid - 4,7 g Sodium ascorbate - 5,9 g Clear fluids - 1000 ml
20.00 - 21.00 Clear fluids 500 ml Receives: Procedure: Full bowel preparation |
| Mechanical bowel preparation only | Active comparator | Day prior to surgery:
17.00 - 18.00 Macrogol-3350 - 100 g Sodium sulfate - 7,5 g Sodium chloride - 2,691 g Potassium chloride - 1,015 g Ascorbic acid - 4,7 g Sodium ascorbate - 5,9 g Clear fluids - 1000 ml
18.00 - 19.00 Clear fluids 500 ml
19.00 - 20.00 Macrogol-3350 - 100 g Sodium sulfate - 7,5 g Sodium chloride - 2,691 g Potassium chloride - 1,015 g Ascorbic acid - 4,7 g Sodium ascorbate - 5,9 g Clear fluids - 1000 ml
20.00 - 21.00 Clear fluids 500 ml Receives: Procedure: Mechanical bowel preparation only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incisional surgical site infection (SSI) rate
Rate of incisional SSI in patients after rectal resections
Measured: 30 days
Secondary outcomes (7)
Anastomotic leak rate
Rate of clinical and/or radiological anastomotic leaks
Measured: 30 days
Intraabdominal and or pelvic abscess rate
Measured: 30 days
Overall morbidity
Rate of patients with any complications after surgery
Measured: 30 days
Rate of intraoperative complications
Measured: Duration of surgical procedure
Surgery duration in minutes
Measured: Duration of surgical procedure
Quality of bowel preparation assessed by surgeon
Assessment of bowel preparation quality by surgeon (qualitative scale)
Measured: Day of surgery
Bowel preparation compliance
Rate of patients in experimental arm undergoing complete bowel preparation according to protocol
Measured: Day of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start30 Oct 2020
- Primary completionAug 2024 (estimated)
- Study completionAug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal 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
- 622 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, National Medical Research Centre of Oncology named after N.N. Petrov
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04592289
- Sponsor's protocol ID
- COL-3
- Acronym
- REPCA
- Status last verified
- Nov 2023
- First submitted
- 12 Oct 2020
- Last updated
- 18 Nov 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 18 Nov 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 Rectal Resections for Cancer Versus MBP Alone
- ClinicalTrials.gov ID
- NCT04592289
- Acronym / sponsor ID
- REPCA / COL-3
- Conditions
- Rectal Cancer
- Keywords
- rectal cancer, bowel preparation, MBP, Oral antibiotics
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 622 participants (estimated)
- Lead sponsor
- N.N. Petrov National Medical Research Center of OncologyUniversity, hospital or other
- Study start
- 30 Oct 2020 (actual)
- Primary completion
- Aug 2024 (estimated)
- Study completion
- Aug 2024 (estimated)
- First posted
- 19 Oct 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 purpose of the study is to determine if short-term outcomes of rectal resections after full bowel preparation (mechanical bowel preparation plus oral antibiotics) are superior to rectal resections with only mechanical bowel preparation.
Detailed description
The design involves random allocation of eligible patients to full bowel preparation or only mechanical bowel preparation in 1:1 ratio. After that rectal 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 surgical site infection is anticipated to decrease from 12% (data from local registry) to 6%. For power of 80% enrolment of 622 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 preparationRifaximin 400 mg twice daily for three days prior to surgery Day prior to surgery: 17.00 - 18.00 Macrogol-3350 - 100 g Sodium sulfate - 7,5 g Sodium chloride - 2,691 g Potassium chloride - 1,015 g Ascorbic acid - 4,7 g Sodium ascorbate - 5,9 g Clear fluids - 1000 ml 18.00 - 19.00 Clear fluids 500 ml 19.00 - 20.00 17.00 - 18.00 Macrogol-3350 - 100 g Sodium sulfate - 7,5 g Sodium chloride - 2,691 g Potassium chloride - 1,015 g Ascorbic acid - 4,7 g Sodium ascorbate - 5,9 g Clear fluids - 1000 ml 20.00 - 21.00 Clear fluids 500 ml |
| Mechanical bowel preparation only | Active comparator | Procedure: Mechanical bowel preparation onlyDay prior to surgery: 17.00 - 18.00 Macrogol-3350 - 100 g Sodium sulfate - 7,5 g Sodium chloride - 2,691 g Potassium chloride - 1,015 g Ascorbic acid - 4,7 g Sodium ascorbate - 5,9 g Clear fluids - 1000 ml 18.00 - 19.00 Clear fluids 500 ml 19.00 - 20.00 Macrogol-3350 - 100 g Sodium sulfate - 7,5 g Sodium chloride - 2,691 g Potassium chloride - 1,015 g Ascorbic acid - 4,7 g Sodium ascorbate - 5,9 g Clear fluids - 1000 ml 20.00 - 21.00 Clear fluids 500 ml |
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 rectum or rectosigmoid junction
- clinical stage T1-4aN0-2M0-1 (distant metastases must be resectable)
- indications for surgical rectal resection
- ECOG status 0-2
- At least 18 years of age
Key exclusion criteria (9 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 preparationMBP+OA | Procedure or surgery | Full bowel preparation (MBP+OA) |
| Mechanical bowel preparation onlyMBP | Procedure or surgery | Mechanical bowel preparation only |
Primary outcome
Incisional surgical site infection (SSI) rate
Time frame: 30 days
Rate of incisional SSI in patients after rectal resections
7 secondary outcomes
Anastomotic leak 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 surgery
Bowel preparation compliance
Time frame: Day of surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 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
National Medical Research Centre of Oncology named after N.N. Petrov
7 sites 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 and Mechanical bowel preparation only in people with Rectal Cancer, run by N.N. Petrov National Medical Research Center of Oncology at 7 sites 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 9 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 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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?
Incisional surgical site infection (SSI) 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 18 Nov 2023.