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

Last updated: November 16, 2023
Sponsor: N.N. Petrov National Medical Research Center of Oncology
Overall Status: Active - Recruiting

Phase

N/A

Condition

Digestive System Neoplasms

Colon Cancer

Rectal Disorders

Treatment

Full bowel preparation

Mechanical bowel preparation only

Clinical Study ID

NCT04592289
COL-3
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • Medical or psychiatric conditions that compromise the patient's ability to giveinformed 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 Design

Total Participants: 622
Treatment Group(s): 2
Primary Treatment: Full bowel preparation
Phase:
Study Start date:
October 30, 2020
Estimated Completion Date:
August 31, 2024

Study 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.

Connect with a study center

  • GBUZ Moscow Clinical Scientific Center named after Loginov MHD

    Moscow,
    Russian Federation

    Active - Recruiting

  • I.M. Sechenov First Moscow State Medical University, Clinic of Oncology, Radiotherapy and Reconstructive Surgery

    Moscow,
    Russian Federation

    Active - Recruiting

  • Lomonosov Moscow State University Medical Research and Educational Center

    Moscow,
    Russian Federation

    Active - Recruiting

  • Ryazan State Clinical Hospital

    Ryazan,
    Russian Federation

    Active - Recruiting

  • Scientific-Research institute of Oncology named after N.N. Petrov

    Saint Petersburg, 197758
    Russian Federation

    Active - Recruiting

  • Tomsk Regional Oncology Hospital

    Tomsk,
    Russian Federation

    Active - Recruiting

  • Volgograd State Medical University, Ministry of Health of Russia

    Volgograd,
    Russian Federation

    Active - Recruiting

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.