Clinical trial NCT04161599: Preoperative Oral Antibiotics With vs Without Mechanical Bowel Preparation to Reduce Surgical Site Infections Following Colonic Resection: an International Randomized Controlled Trial.
Official title: Oral + Parenteral Antibiotic Prophylaxis Before Colonic Surgery With vs Without Mechanical Bowel Preparation: a Prospective, Multicentric, Randomised, Controlled Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Wounds and Injuries
Surgery--Complications
Lead sponsor: Hospital Universitari Vall d'Hebron Research Institute
Sponsor class: OTHER
First posted: 2019-11-13
Enrollment: 968
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Detailed description: International, multicentre, pragmatic, parallel-group, randomised controlled trial.

Routine antibiotics for the intravenous and oral prophylaxis of colorectal surgery will be used.

Experimental group: Patients undergoing elective colonic surgery that involves colonic resection.

The antibiotic prophylaxis in this group will be composed of:

An oral antibiotic pattern of ciprofloxacin (750mg / 12h, 2 doses) and metronidazole (250mg / 8h, 3 doses) the day before surgery, plus mechanical bowel preparation with Sodium picosulfate, light magnesium oxide, and anhydrous citric acid (10 mg - 3.5 g - 10.97 g per dose/ 2 doses the day before surgery) + An intravenous antibiotics pattern of cefuroxime 1,5 g and metronidazole 1 g at anesthetic induction.

Control group: Patients undergoing elective colonic surgery that involves colonic resection.

The antibiotic prophylaxis in this group will be composed of:

An oral antibiotic pattern of ciprofloxacin (750mg / 12h, 2 doses) and metronidazole (250mg / 8h, 3 doses)

+ An intravenous antibiotic pattern of cefuroxime 1,5 g and metronidazole 1 gr at anesthetic induction.

In both groups a second intravenous dose of cefuroxime (750mg) will be administered if the intraoperative time prolongs for more than three hours or if there is an intraoperative bleeding over 1000cc.

There will not be a placebo treatment. Subject compliance will be evaluated according to the usual practice in surgical care field

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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
* Patients with ascites or rhabdomyolysis

Primary outcomes:
measure: Rate of Wound infection
timeFrame: 30 days
Secondary outcomes:
measure: Local complications
timeFrame: 30 days after surgery
measure: Impaired healing
timeFrame: 30 days after surgery
measure: Occlusive problems
timeFrame: 30 days from surgery
measure: Nephro-urinary complications
timeFrame: 30 days after surgery
measure: Adverse events related to drugs (Harms)
timeFrame: 30 days after surgery
measure: Time to complete recovery
timeFrame: 30 days after surgery
measure: Length of Hospital stay
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 7 days
measure: Iatrogenic problems
timeFrame: 30 days after surgery
measure: Bleeding problems
timeFrame: 30 days after surgery
measure: Cardiac complications
timeFrame: 30 days after surgery
measure: Respiratory complications
timeFrame: 30 days after surgery
measure: Neurological complications
timeFrame: 30 days after surgery
measure: Postoperative intestinal problems
timeFrame: 30 days after surgery
measure: Readmission
timeFrame: 30 days after surgery
measure: Reintervention
timeFrame: 30 days after surgery
measure: Perioperative Hypovolemia
timeFrame: Intraoperative assessment
measure: Patient satisfaction with preparation received
timeFrame: within the 30 days from surgery
measure: Death
timeFrame: 30 days after surgery
measure: Anastomotic leak
timeFrame: 30 days after surgery
Other outcomes:
measure: Complications at 60 days of follow up
timeFrame: 60 days after surgery
measure: Complications at 5 years of follow up
timeFrame: 5 years after surgery
Locations:
city: Nanjing
country: China
facility: Jinling Hospital
city: Patra
country: Greece
facility: General University Hospital of Patras
city: Rozzano
country: Italy
facility: Humanitas Research Hospital
city: Tomsk
country: Russian Federation
facility: Tomsk Oncological Hospital
city: Barcelona
country: Spain
facility: Hospital General Universitario Vall d´Hebron
state: Barcelona, Spain
city: Barcelona
country: Spain
facility: Hospital de Bellvitge
state: Hospitalet De Llobregat, Barcelona, Spain
city: Cruces
country: Spain
facility: Hospital Universitario Cruces
city: Lugo
country: Spain
facility: Hospital Universitario Lucus Augusti
city: Madrid
country: Spain
facility: Hospital Universitario Ramón y Cajal
city: London
country: United Kingdom
facility: Royal Marsden Hospital, Imperial College of London
Study officials:
affiliation: Hospital Universitario Valle de Hebron, Barcelona
name: Eloy Espín-Basany, MD PhD
role: STUDY_CHAIR
affiliation: Hospital Universitario Valle de Hebron, Barcelona
name: Gianluca Pellino, MD, PhD
role: STUDY_DIRECTOR
affiliation: Hospital Universitario Valle de Hebron, Barcelona
name: Alejandro Solís-Peña, MD, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.