Short-term Outcomes of Full Bowel Preparation (MBP+OA) for Rectal Resections for Cancer Versus MBP Alone (REPCA)

November 16, 2023 updated by: N.N. Petrov National Medical Research Center of Oncology
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

622

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Russian Federation
      • Moscow, Russian Federation
        • Recruiting
        • GBUZ Moscow Clinical Scientific Center named after Loginov MHD
        • Contact:
        • Principal Investigator:
          • Oleg Knyazev
        • Sub-Investigator:
          • Georgy Saakyan
      • Moscow, Russian Federation
        • Recruiting
        • I.M. Sechenov First Moscow State Medical University, Clinic of Oncology, Radiotherapy and Reconstructive Surgery
        • Contact:
        • Principal Investigator:
          • Fedor Vetshev
        • Sub-Investigator:
          • Liliya Polishchuk
      • Moscow, Russian Federation
        • Recruiting
        • Lomonosov Moscow State University Medical Research and Educational Center
        • Contact:
        • Principal Investigator:
          • Mikhail Agapov
        • Sub-Investigator:
          • Tatiana Garmanova
      • Ryazan, Russian Federation
        • Recruiting
        • Ryazan State Clinical Hospital
        • Contact:
        • Principal Investigator:
          • Ivan Ignatov
      • Saint Petersburg, Russian Federation, 197758
        • Recruiting
        • Scientific-Research institute of Oncology named after N.N. Petrov
        • Contact:
        • Principal Investigator:
          • Aleksei Karachun
        • Sub-Investigator:
          • Aleksei Petrov
      • Tomsk, Russian Federation
        • Recruiting
        • Tomsk Regional Oncology Hospital
        • Contact:
        • Principal Investigator:
          • Evgeniy Drozdov
      • Volgograd, Russian Federation
        • Recruiting
        • Volgograd State Medical University, Ministry of Health of Russia
        • Contact:
        • Principal Investigator:
          • Victoriya Zhavoronkova
        • Sub-Investigator:
          • Mikhail Postolov

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • Indications for obstructive resection or abdominoperineal excision
  • Acute bowel obstruction, bleeding or perforation
  • Other malignancies not in remission

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Procedure: Full bowel preparation
MBP+OA
Active Comparator: 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
Procedure: Mechanical bowel preparation only
MBP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incisional surgical site infection (SSI) rate
Time Frame: 30 days
Rate of incisional SSI in patients after rectal resections
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anastomotic leak rate
Time Frame: 30 days
Rate of clinical and/or radiological anastomotic leaks
30 days
Intraabdominal and or pelvic abscess rate
Time Frame: 30 days
30 days
Overall morbidity
Time Frame: 30 days
Rate of patients with any complications after surgery
30 days
Rate of intraoperative complications
Time Frame: Duration of surgical procedure
Duration of surgical procedure
Surgery duration in minutes
Time Frame: Duration of surgical procedure
Duration of surgical procedure
Quality of bowel preparation assessed by surgeon
Time Frame: Day of surgery
Assessment of bowel preparation quality by surgeon (qualitative scale)
Day of surgery
Bowel preparation compliance
Time Frame: Day of surgery
Rate of patients in experimental arm undergoing complete bowel preparation according to protocol
Day of surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

N.N. Petrov National Medical Research Center of Oncology

Investigators

  • Study Chair: Aleksei Karachun, National Medical Research Centre of Oncology named after N.N. Petrov

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 30, 2020

Primary Completion (Estimated)

August 1, 2024

Study Completion (Estimated)

August 1, 2024

Study Registration Dates

First Submitted

October 12, 2020

First Submitted That Met QC Criteria

October 12, 2020

First Posted (Actual)

October 19, 2020

Study Record Updates

Last Update Posted (Estimated)

November 17, 2023

Last Update Submitted That Met QC Criteria

November 16, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COL-3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

We are not planning to share individual participant data

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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