NCT03563586

Brief Summary

Investigation of the role of adding oral antibiotics to preoperative mechanical bowel preparation before colorectal surgery for cancer.

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
210

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2018

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

Study Start

First participant enrolled

April 1, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 9, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 20, 2018

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2021

Completed
Last Updated

September 11, 2020

Status Verified

September 1, 2020

Enrollment Period

3 years

First QC Date

June 9, 2018

Last Update Submit

September 10, 2020

Conditions

AntibioticBowel CancerColorectal CancerSurgical Site Infection

Keywords

oral antibioticmechanical bowel preparationcolorectal cancersurgical site infection

Outcome Measures

Primary Outcomes (1)

  • Surgical Site Infections

    Surgical Site Infections

    30 days

Secondary Outcomes (7)

  • Anastomotic leaks

    30 days

  • Other surgical and non-surgical compliactions

    30 days

  • Hospital length of stay

    30 days

  • Readmission rate

    30 days

  • Patients' preparation tolerance

    30 days

  • +2 more secondary outcomes

Study Arms (2)

Bowel Preparation plus antibiotics

ACTIVE COMPARATOR

Preoperative oral antibiotic therapy with rifaximin 400 mg plus metronidazole 500mg the day prior to surgery at 2:00, 3:00 and 10:00 pm, with mechanical bowel preparation (2 vials sodium phospate 45ml at 1:00 and 7:00 pm)

Other: Bowel Preparation plus antibiotics

Bowel Preparation

OTHER

Preoperative mechanical bowel preparation (2 vials sodium phospate 45ml at 1:00 and 7:00 pm)

Other: Bowel Preparation

Interventions

Bowel Preparation plus antibioticsOTHER

Preoperative oral antibiotic therapy with rifaximin 400 mg plus metronidazole 500mg the day prior to surgery at 2:00, 3:00 and 10:00 pm, with mechanical bowel preparation (2 vials sodium phospate 45ml at 1:00 and 7:00 pm)

Bowel Preparation plus antibiotics
Bowel PreparationOTHER

Mechanical Bowel Preparation (2 vials sodium phospate 45ml at 1:00 and 7:00 pm) alone Both groups will receive iv antibiotics (cefoxitin 2 gr plus metronidazole 500gr) perioperatively and discontinuation within 24 hours

Bowel Preparation

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Scheduled colorectal cancer surgery

You may not qualify if:

  • Emergency surgery
  • Obstructive and perforated cancer
  • Intolerance to bowel preparation regimen
  • Allergies to orally administered antibiotics

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NKUAthens

Athens, 11528, Greece

RECRUITING

Related Publications (2)

  • Frountzas M, Michalopoulou V, Georgiou G, Kanata D, Matiatou M, Kimpizi D, Matthaiou G, Spiliotopoulos S, Vouros D, Toutouzas KG, Theodoropoulos GE. The Impact of Mechanical Bowel Preparation and Oral Antibiotics in Colorectal Cancer Surgery (MECCA Study): A Prospective Randomized Clinical Trial. J Clin Med. 2024 Feb 19;13(4):1162. doi: 10.3390/jcm13041162.

    PMID: 38398474DERIVED

  • Willis MA, Toews I, Soltau SL, Kalff JC, Meerpohl JJ, Vilz TO. Preoperative combined mechanical and oral antibiotic bowel preparation for preventing complications in elective colorectal surgery. Cochrane Database Syst Rev. 2023 Feb 7;2(2):CD014909. doi: 10.1002/14651858.CD014909.pub2.

    PMID: 36748942DERIVED

MeSH Terms

Conditions

Intestinal NeoplasmsColorectal NeoplasmsSurgical Wound Infection

Interventions

Anti-Bacterial AgentsCathartics

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesColonic DiseasesRectal DiseasesWound InfectionInfectionsPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anti-Infective AgentsTherapeutic UsesPharmacologic ActionsChemical Actions and UsesGastrointestinal Agents

Study Officials

  • George Theodoropoulos

    National and Kapodistrian University of Athens

    PRINCIPAL INVESTIGATOR

Central Study Contacts

George Theodoropoulos

CONTACT

+306945463593georgetheocrs@live.com

Georgia Georgiou

CONTACT

+306945292510georgia_cy@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 9, 2018

First Posted

June 20, 2018

Study Start

April 1, 2018

Primary Completion

April 1, 2021

Study Completion

June 1, 2021

Last Updated

September 11, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations

GR(1)