NCT05546892

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
586

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 15, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 21, 2022

Completed
5 months until next milestone

Study Start

First participant enrolled

February 10, 2023

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2025

Completed
Last Updated

March 29, 2023

Status Verified

March 1, 2023

Enrollment Period

2.6 years

First QC Date

September 15, 2022

Last Update Submit

March 28, 2023

Conditions

Colon Cancer

Keywords

colon cancerMBPbowel preparationoral antibiotics

Outcome Measures

Primary Outcomes (1)

  • Anastomotic leak rate

    Rate of anastomotic leak in patients after colon resections

    30 days

Secondary Outcomes (7)

  • Surgical site infection (SSI) rate

    30 days

  • Intraabdominal and or pelvic abscess rate

    30 days

  • Overall morbidity

    30 days

  • Rate of intraoperative complications

    Duration of surgical procedure

  • Surgery duration in minutes

    Duration of surgical procedure

  • +2 more secondary outcomes

Study Arms (2)

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

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)

Procedure: No bowel preparation

Interventions

Full bowel preparation prior to colon resection for cancerPROCEDURE

Mechanical bowel preparation and oral antibiotics

Full bowel preparation (MBP+OA)
No bowel preparationPROCEDURE

Omission of any bowel preparation

No bowel preparation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • Functioning stoma
  • Contraindications for use of MBP or OA drugs or their components
  • Indications for mandatory MBP (planned intraoperative colonoscopy etc)
  • Indications for obstructive resection
  • Acute bowel obstruction, bleeding or perforation
  • Other malignancies not in remission

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

N.N. Petrov National Medical Research Center of Oncology

Saint Petersburg, 197758, Russia

RECRUITING

MeSH Terms

Conditions

Colonic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal Diseases

Study Officials

  • Aleksei Karachun

    N.N. Petrov National Medical Research Center of Oncology

    STUDY CHAIR

Central Study Contacts

Aleksei Karachun

CONTACT

+79219462123dr.a.karachun@gmail.com

Aleksei Petrov

CONTACT

+79214117866alexpetrov@doctor.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 15, 2022

First Posted

September 21, 2022

Study Start

February 10, 2023

Primary Completion

September 1, 2025

Study Completion

September 1, 2025

Last Updated

March 29, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

We are not planning to share individual participant data

Locations

RU(1)