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

NCT04161599 | Unknown Phase 4 DMC

• 1 other identifier: 2019-004283-21
• Study Type: interventional
• Target: 968
• Locations: 6 countries
• Sites: 10

Brief 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

Outcome Measures

Primary Outcomes (1)

• Rate of Wound infection

  Superficial, deep, body-cavity This is a Clinical measure supported by image if necessary All the morbidity problems are reported independently

  30 days

Secondary Outcomes (19)

• Local complications

  30 days after surgery

• Impaired healing

  30 days after surgery

• Occlusive problems

  30 days from surgery

• Nephro-urinary complications

  30 days after surgery

• Adverse events related to drugs (Harms)

  30 days after surgery

Other Outcomes (2)

• Complications at 60 days of follow up

  60 days after surgery

• Complications at 5 years of follow up

  5 years after surgery

Study Arms (2)

Oral + Parenteral prophylaxis + Mechanical Bowel Preparation

EXPERIMENTAL

Drug: Extra dosage - cefuroxime (750mg) I.V Procedure: Colonic Surgery Both groups undergo colonic surgery. This section does not include rectal surgery ( see Inclusion/exclusion criteria) Drug: Cefuroxime 750mg oral An oral antibiotic pattern of ciprofloxacin (750mg / 12h, 2 doses) the day before surgery. Drug: Metronidazole 250mg oral An oral antibiotic pattern of metronidazole (250mg / 8h, 3 doses) the day before surgery. Drug: Sodium picosulfate, magnesium oxide, citric acid anhydrous 15.08 g oral An oral laxative for bowel cleansing (2 doses) the day before surgery. Drug: Metronidazole 1 g Intravenous An intravenous antibiotic pattern of metronidazole 1 g during anesthetic induction. Drug: Cefuroxime 1,5 g Intravenous An intravenous antibiotic pattern of cefuroxime 1,5 g during anesthetic induction.

Drug: Cefuroxime (750mg) I.V; Procedure: Colonic Surgery; Drug: Cefuroxime 750mg oral; Drug: Metronidazole 250 MG Oral Tablet [Flagyl]; Drug: Metronidazole 1 g Intravenous; Drug: Cefuroxime 1,5 g Intravenous; Drug: Sodium picosulfate, light magnesium oxide, anhydrous citric acid 10 mg/3.5 g/10.97 g Oral

Oral + Parenteral prophylaxis

ACTIVE COMPARATOR

Drug: Extra dosage - cefuroxime (750mg) I.V In both groups a second intravenous dose of cefuroxime (750mg) will be administered if the intraoperative time elongates more than three hours or there is an intraoperative bleeding over 1000cc Procedure: Colonic Surgery Both groups undergo colonic surgery. This section does not include rectal surgery ( see Inclusion/exclusion criteria) Drug: Cefuroxime 750mg oral An oral antibiotic pattern of ciprofloxacin (750mg / 12h, 2 doses) the day before surgery. Drug: Metronidazole 250mg oral An oral antibiotic pattern of metronidazole (250mg / 8h, 3 doses) the day before surgery. Drug: Metronidazole 1 gr Intravenous An intravenous antibiotic pattern of metronidazole 1 g during anesthetic induction. Drug: Cefuroxime 1,5 g Intravenous An intravenous antibiotic pattern of cefuroxime 1,5 g during anesthetic induction.

Drug: Cefuroxime (750mg) I.V; Procedure: Colonic Surgery; Drug: Cefuroxime 750mg oral; Drug: Metronidazole 250 MG Oral Tablet [Flagyl]; Drug: Metronidazole 1 g Intravenous; Drug: Cefuroxime 1,5 g Intravenous

Interventions

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

Laxative for bowel cleansing

Oral + Parenteral prophylaxis + Mechanical Bowel Preparation

Cefuroxime (750mg) I.V DRUG

Extra dosage

Oral + Parenteral prophylaxis; Oral + Parenteral prophylaxis + Mechanical Bowel Preparation

Colonic Surgery PROCEDURE

Colonic Surgery

Oral + Parenteral prophylaxis; Oral + Parenteral prophylaxis + Mechanical Bowel Preparation

Cefuroxime 750mg oral DRUG

Oral prophylaxis

Oral + Parenteral prophylaxis; Oral + Parenteral prophylaxis + Mechanical Bowel Preparation

Metronidazole 250 MG Oral Tablet [Flagyl] DRUG

Oral prophylaxis

Oral + Parenteral prophylaxis; Oral + Parenteral prophylaxis + Mechanical Bowel Preparation

Metronidazole 1 g Intravenous DRUG

IV prophylaxis

Oral + Parenteral prophylaxis; Oral + Parenteral prophylaxis + Mechanical Bowel Preparation

Cefuroxime 1,5 g Intravenous DRUG

IV prophylaxis

Oral + Parenteral prophylaxis; Oral + Parenteral prophylaxis + Mechanical Bowel Preparation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients of both genders, aged 18 years or above, with colonic disease without contraindications to surgical treatment, diagnosed with neoplasia or diverticular disease (diverticulosis with indication to elective surgery: stricture, chronic constipation), patients for whom a segmental or total colectomy is indicated.
• Patients who voluntarily accept to join the study and sign a dedicated written consent.
• Capability of understanding the study and take the medications prescribed.

You may not qualify if:

• Patients undergoing urgent surgery or no elective admission
• Patients who refuse to participate
• Patients with rectal disease or neoplasia
• Patients with pre-existing intrabdominal sepsis (abscess, acute diverticulitis)
• Patients who received preoperative antibiotic treatment for any other reasons during the two weeks before surgery
• Patients with Crohn's disease or ulcerative colitis
• Patients unlikely to adhere to the treatment prescribed
• Patients with allergy or contraindication to the medications used in the study
• Patients who need mechanical bowel preparation
• Patients with contraindication to bowel preparation used in the study (Citrafleet®):
• Patients with kidney failure needing haemodialysis or with hypermagnesemia
• Patients with severe heart failure
• Patients with gastric or duodenal ulcer
• Patients with mechanical obstruction
• Patients with toxic megacolon

Sponsors & Collaborators

• Hospital Universitari Vall d'Hebron Research Institute: lead

Study Sites (10)

Jinling Hospital

Nanjing, China

RECRUITING

General University Hospital of Patras

Pátrai, Greece

RECRUITING

Humanitas Research Hospital

Rozzano, Italy

RECRUITING

Tomsk Oncological Hospital

Tomsk, Russia

RECRUITING

Hospital General Universitario Vall d´Hebron

Barcelona, Barcelona, Spain, 08035, Spain

RECRUITING

Hospital de Bellvitge

Barcelona, Hospitalet de Llobregat, Barcelona, Spain, 08907, Spain

RECRUITING

Hospital Universitario Cruces

Cruces, Spain

RECRUITING

Hospital Universitario Lucus Augusti

Lugo, Spain

RECRUITING

Hospital Universitario Ramón y Cajal

Madrid, Spain

RECRUITING

Royal Marsden Hospital, Imperial College of London

London, United Kingdom

NOT YET RECRUITING

Related Publications (3)

• Pellino G, Solis-Pena A, Kraft M, Huguet BM, Espin-Basany E. Preoperative oral antibiotics with versus without mechanical bowel preparation to reduce surgical site infections following colonic resection: Protocol for an international randomized controlled trial (ORALEV2). Colorectal Dis. 2021 Aug;23(8):2173-2181. doi: 10.1111/codi.15681. Epub 2021 May 12.

  PMID: 33872448 RESULT

• 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: 36748942 DERIVED

• Koskenvuo L, Sallinen V. Preoperative oral antibiotics in colon surgery. Lancet Gastroenterol Hepatol. 2020 Sep;5(9):801-802. doi: 10.1016/S2468-1253(20)30203-X. No abstract available.

  PMID: 32818460 DERIVED

MeSH Terms

Conditions

Wounds and Injuries

Interventions

Cefuroxime; Metronidazole; Tablets; picosulfate sodium; Citric Acid

Intervention Hierarchy (Ancestors)

Cephalosporins; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nitroimidazoles; Nitro Compounds; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Dosage Forms; Pharmaceutical Preparations; Citrates; Tricarboxylic Acids; Acids, Acyclic; Carboxylic Acids

Study Officials

• Eloy Espín-Basany, MD PhD

  Hospital Universitario Valle de Hebron, Barcelona

  STUDY CHAIR

• Gianluca Pellino, MD, PhD

  Hospital Universitario Valle de Hebron, Barcelona

  STUDY DIRECTOR

• Alejandro Solís-Peña, MD, PhD

  Hospital Universitario Valle de Hebron, Barcelona

  STUDY DIRECTOR

Central Study Contacts

Eloy Espín-Basany, MD PhD

CONTACT

934 893 000; eespin@vhebron.net

Gianluca Pellino, MD, PhD

CONTACT

934 893 000; gpellino@vhebron.net

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2019
• First Posted: November 13, 2019
• Study Start: March 1, 2022
• Primary Completion: June 1, 2024
• Study Completion: July 1, 2024
• Last Updated: April 26, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (5); RU (1); IT (1); GR (1); CN (1); GB (1)