Mechanical Bowel Preparation With or Without Oral Antibiotics for Colorectal Cancer Surgery

NCT ID: NCT03563586

Last Updated: 2020-09-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 210 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-01
• Study Completion Date: 2021-06-01

Brief Summary

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

Detailed Description

The aim of the study is to investigate whether the addition of oral antibiotics to Mechanical Bowel Preparation (MBP) prior to colorectal cancer surgical procedures reduce the superfical and deep surgical site (SSI) infectious complications. The study is prospective and is designed in a randomized single-blinded controlled fashion. It is taking place at one academic surgical unit of Athens Medical School, located at a tertiary referal institution. Patients scheduled to undergo an elective surgical resection for colon or rectal cancer will be allocated to either formal MBP the day before surgery or a combined MBP with administration of oral antibiotics. Exclusion criteria are the following: emergency surgery, obstructive or perforated cancer, patients intolerance to bowel preparation regimen and allergies to orally administered antibiotics.

Intervention arms: Patients will be randomised into two groups, concealed from the treating surgeon.

Group A:

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 MBP (2 vials sodium phospate 45ml at 1:00 and 7:00 pm)

Group B:

MBP (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.

Outcome measures: The primary end point is surgical site infection (SSI), including (i) superficial wound infection, (ii) deep wound infection, and (iii) intrabdominal infection (contaminated fluid or pus collection) within 30 days of the procedure (decrease 3% in the rate) Secondary measures: Anastomotic leaks, other surgical and non-surgical compliactions, hospital length of stay, readmission rate, patients' preparation tolerance, preparation regimens side-effects, time to beginning of adjuvant treatment for colorectal cancer.

Sample Size: It is estimated that 105 patients per treatment arm are needed.

Conditions

Antibiotic; Bowel Cancer; Colorectal Cancer; Surgical Site Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Bowel Preparation plus antibiotics

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)

Group Type: ACTIVE_COMPARATOR

Bowel Preparation plus antibiotics

Intervention Type: OTHER

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

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

Group Type: OTHER

Bowel Preparation

Intervention Type: OTHER

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

Interventions

Bowel Preparation plus antibiotics

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)

Intervention Type: OTHER

Bowel Preparation

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Scheduled colorectal cancer surgery

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National and Kapodistrian University of Athens

OTHER

Sponsor Role: lead

Responsible Party

George Theodoropoulos

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

George Theodoropoulos

Role: PRINCIPAL_INVESTIGATOR

National and Kapodistrian University of Athens

Locations

NKUAthens

Athens, , Greece

Site Status: RECRUITING

Countries

Greece

Central Contacts

George Theodoropoulos

Role: CONTACT

georgetheocrs@live.com

+306945463593

Georgia Georgiou

Role: CONTACT

georgia_cy@hotmail.com

+306945292510

Facility Contacts

George Theodoropoulos

Role: primary

6945463593

References

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.

Reference Type: DERIVED

PMID: 38398474 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 36748942 (View on PubMed)

Other Identifiers

56/14-3-2018

Identifier Type: -

Identifier Source: org_study_id