Short-term Outcomes of Full Bowel Preparation (MBP+OA) for Rectal Resections for Cancer Versus MBP Alone
NCT ID: NCT04592289
Last Updated: 2023-11-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
622 participants
INTERVENTIONAL
2020-10-30
2024-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study of Preoperative Radiation Therapy and Capecitabine in Locally Advanced Rectal Cancer
NCT00122291
Preoperative Hyperfractionated Radiotherapy or Radiochemotherapy in Locally Advanced Rectal Cancer.
NCT01814969
Short-course Preoperative Chemoradiotherapy Followed by Delayed Operation for Locally Advanced Rectal Cancer
NCT01129700
Sphincter-preserving Surgery After Preoperative Treatment of Ultra-low Rectal Carcinoma
NCT00979680
Organ-preserving Management in Patients With Complete or Near-complete Tumour Response After Preoperative Radio(Chemo)Therapy for Rectal Cancer
NCT04095468
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Full bowel preparation (MBP+OA)
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
Full bowel preparation
MBP+OA
Mechanical bowel preparation only
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
Mechanical bowel preparation only
MBP
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Full bowel preparation
MBP+OA
Mechanical bowel preparation only
MBP
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
Exclusion Criteria
* 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
* Indications for obstructive resection or abdominoperineal excision
* Acute bowel obstruction, bleeding or perforation
* Other malignancies not in remission
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
N.N. Petrov National Medical Research Center of Oncology
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Aleksei Karachun
Role: STUDY_CHAIR
National Medical Research Centre of Oncology named after N.N. Petrov
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
GBUZ Moscow Clinical Scientific Center named after Loginov MHD
Moscow, , Russia
I.M. Sechenov First Moscow State Medical University, Clinic of Oncology, Radiotherapy and Reconstructive Surgery
Moscow, , Russia
Lomonosov Moscow State University Medical Research and Educational Center
Moscow, , Russia
Ryazan State Clinical Hospital
Ryazan, , Russia
Scientific-Research institute of Oncology named after N.N. Petrov
Saint Petersburg, , Russia
Tomsk Regional Oncology Hospital
Tomsk, , Russia
Volgograd State Medical University, Ministry of Health of Russia
Volgograd, , Russia
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
COL-3
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.