Preoperative Oral Antibiotics With vs Without Mechanical Bowel Preparation to Reduce Surgical Site Infections Following Colonic Resection: an International Randomized Controlled Trial.

Summary

The ORALEV Study found that preoperative oral antibiotics can reduce the incidence of surgical site infections after colonic resection, compared with no preparation.

The role of mechanical bowel preparation in patients needing colonic surgery is yet to be elucidated.

No randomised controlled trials have assessed the impact of mechanical bowel preparation combined with oral antibiotics on the incidence of surgical site infections after colonic surgery, compared with oral antibiotics only.

Conditions

• Wounds and Injuries
• Surgery--Complications

Interventions

DRUG

Cefuroxime (750mg) I.V

Extra dosage

PROCEDURE

Colonic Surgery

Colonic Surgery

DRUG

Cefuroxime 750mg oral

Oral prophylaxis

DRUG

Metronidazole 250 MG Oral Tablet [Flagyl]

Oral prophylaxis

DRUG

Metronidazole 1 g Intravenous

IV prophylaxis

DRUG

Cefuroxime 1,5 g Intravenous

IV prophylaxis

DRUG

Sodium picosulfate, light magnesium oxide, anhydrous citric acid 10 mg/3.5 g/10.97 g Oral

Laxative for bowel cleansing

Sponsors & Collaborators

• Hospital Universitari Vall d'Hebron Research Institute

  lead OTHER

Principal Investigators

• Eloy Espín-Basany, MD PhD · Hospital Universitario Valle de Hebron, Barcelona

• Gianluca Pellino, MD, PhD · Hospital Universitario Valle de Hebron, Barcelona

• Alejandro Solís-Peña, MD, PhD · Hospital Universitario Valle de Hebron, Barcelona

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-03-01

Primary Completion

2024-06-30

Completion

2024-07-31

Countries

• China
• Greece
• Italy
• Russia
• Spain
• United Kingdom

Study Locations