Wounds and InjuriesPhase 4ORALEV2NCT04161599
Preoperative Oral Antibiotics With vs Without Mechanical Bowel Preparation to Reduce Surgical Site Infections Following Colonic Resection: an International Randomized Controlled Trial.
A Phase 4 study testing Cefuroxime (750mg) I.V, Colonic Surgery and Cefuroxime 750mg oral in people with Wounds and Injuries and Surgery--Complications, run by Hospital Universitari Vall d'Hebron Research Institute at 10 sites in 6 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wounds and Injuries, Surgery--Complications
- What is being tested?
- Cefuroxime (750mg) I.V, Colonic Surgery and Cefuroxime 750mg oral
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 968 participants
- Where
- 10 sitesin 6 countries
- Study dates
- 1 Mar 2022to Jul 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
10 sites in 6 countries.
10 sites in 6 countries
Spain5 sites, 5 recruiting
- Recruiting
Hospital General Universitario Vall d´Hebron
Barcelona, Barcelona, Spain, 08035
Eloy Espín Basany, MD PhD, 934 893 000 ext. 6587, eespin@mac.com
María Martínez Lopez, MD, m.martinez.21@vhebron.net
- Recruiting
Hospital de Bellvitge
Barcelona, Hospitalet de Llobregat, Barcelona, Spain, 08907
Sebastiano Biondo, MD PhD, 932 607 500
- Recruiting
Hospital Universitario Cruces
Cruces
José María García González
- Recruiting
Hospital Universitario Lucus Augusti
Lugo
Manuel Muinelo
- Recruiting
Hospital Universitario Ramón y Cajal
Madrid
Juan Ocaña Jiménez, jocajim@gmail.com
China1 site, 1 recruiting
- Recruiting
Jinling Hospital
Nanjing
Huajian Ren, rhj1288@hotmail.com
Greece1 site, 1 recruiting
- Recruiting
General University Hospital of Patras
Pátrai
Francesck Mulita
Italy1 site, 1 recruiting
- Recruiting
Humanitas Research Hospital
Rozzano
Antonino Spinelli
Annalisa Maroli
Russia1 site, 1 recruiting
- Recruiting
Tomsk Oncological Hospital
Tomsk
Eugeniy Drozdov
United Kingdom1 site, 1 recruiting
- Not yet recruiting
Royal Marsden Hospital, Imperial College of London
London
Christos Kontovounisios
About this study
Official title: Oral + Parenteral Antibiotic Prophylaxis Before Colonic Surgery With vs Without Mechanical Bowel Preparation: a Prospective, Multicentric, Randomised, Controlled Trial.
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.
Read the 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
- Conditions
- Wounds and Injuries, Surgery--Complications
- Being tested
- Cefuroxime (750mg) I.V, Colonic Surgery, Cefuroxime 750mg oral, Metronidazole 250 MG Oral Tablet [Flagyl], Metronidazole 1 g Intravenous
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cefuroxime (750mg) I.VDrug
Extra dosage
Colonic SurgeryProcedure or surgery
Colonic Surgery
Cefuroxime 750mg oralDrug
Oral prophylaxis
Metronidazole 250 MG Oral Tablet [Flagyl]Drug
Oral prophylaxis
Metronidazole 1 g IntravenousDrug
IV prophylaxis
Cefuroxime 1,5 g IntravenousDrug
IV prophylaxis
Sodium picosulfate, light magnesium oxide, anhydrous citric acid 10 mg/3.5 g/10.97 g OralDrug
Laxative for bowel cleansing
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 30 days
Secondary outcomes (19)
Local complications
Hematoma, seroma, evisceration
This is a Clinical measure. This morbidity problems are reported independently as a YES/NO variable
Measured: 30 days after surgery
Impaired healing
This is a Clinical measure always supported by image tests. This morbidity problems are reported independently as a YES/NO variable
Measured: 30 days after surgery
Occlusive problems
Intestinal occlusion, Anastomotic stenosis, Postoperative ileus
Measured: 30 days from surgery
Nephro-urinary complications
Acute urinary retention, Acute renal failure, cystitis, pyelonephritis ...
This is a Clinical measure supported by more specific tests if necessary. This morbidity problems are reported independently as a YES/NO variable
Measured: 30 days after surgery
Adverse events related to drugs (Harms)
Any adverse event related with the drug
•This morbidity problems are reported independently as a YES/NO variable
Measured: 30 days after surgery
Time to complete recovery
Interval between hospital admission and complete recovery ("can be discharged")
Measured: 30 days after surgery
Length of Hospital stay
Hospital stay since colorectal surgery is done
Measured: Participants will be followed for the duration of hospital stay, an expected average of 7 days
Iatrogenic problems
Injury to structures such as ureters, bowel loops artery / veins .
•This morbidity problems are reported independently as a YES/NO variable
Measured: 30 days after surgery
Bleeding problems
Hemoperitoneum, abdominal hematoma,anastomotic bleeding
•This morbidity problems are reported independently as a YES/NO variable
Measured: 30 days after surgery
Cardiac complications
Acute myocardial infarction, angor pectoris , atrial fibrillation, acute pulmonary edema
This is a Clinical measure supported by more specific tests if necessary. This morbidity problems are reported independently as a YES/NO variable Cardiologist report will be required for including this items
Measured: 30 days after surgery
Respiratory complications
Pneumonia, Atelectasia, Pulmonary embolism, ARDS
This is a Clinical measure always supported by image . This morbidity problems are reported independently as a YES/NO variable
Measured: 30 days after surgery
Neurological complications
Disorientation, cerebral vascular accident,
This is a Clinical measure. This morbidity problems are reported independently as a YES/NO variable. Neurologist report will be required beyond disorientation.
Measured: 30 days after surgery
Postoperative intestinal problems
Postoperative diarrhoea, nausea and vomiting
Measured: 30 days after surgery
Readmission
Need to be readmitted after discharge
Measured: 30 days after surgery
Reintervention
Need to be reoperated
Measured: 30 days after surgery
Perioperative Hypovolemia
Signs or symptoms of hypovolemia not related with bleeding, as assessed by the anesthetist at surgery
Measured: Intraoperative assessment
Patient satisfaction with preparation received
Patient satisfaction with the preparation receivced, assessed with a Verbal Rating Scale (VRS) from 1 (minimum satisfaction) to 10 (maximum satisfaction)
Measured: within the 30 days from surgery
Death
Patient death for any cause and patient death in relation with treatment received
Measured: 30 days after surgery
Anastomotic leak
clinical, radiological or intraoperatively detected abdominal or pelvic leak or collection
Measured: 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2019
- Study start1 Mar 2022
- Primary completionJun 2024 (estimated)
- Study completionJul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Wounds and InjuriesStudies of the same condition, open and under way.
- More trials run by Hospital Universitari Vall d'Hebron Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 968 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eloy Espín-Basany, MD PhD, Study chair, Hospital Universitario Valle de Hebron, BarcelonaGianluca Pellino, MD, PhD, Study director, Hospital Universitario Valle de Hebron, BarcelonaAlejandro Solís-Peña, MD, PhD, Study director, Hospital Universitario Valle de Hebron, Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04161599
- Sponsor's protocol ID
- 2019-004283-21
- Other IDs
- 2019
- Acronym
- ORALEV2
- Status last verified
- Apr 2022
- First submitted
- 4 Nov 2019
- Last updated
- 26 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33872448Willis 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.
PubMed 36748942Koskenvuo 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.
PubMed 32818460
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral + Parenteral Antibiotic Prophylaxis Before Colonic Surgery With vs Without Mechanical Bowel Preparation: a Prospective, Multicentric, Randomised, Controlled Trial.
- ClinicalTrials.gov ID
- NCT04161599
- Acronym / sponsor ID
- ORALEV2 / 2019-004283-21
- Conditions
- Wounds and Injuries, Surgery--Complications
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 968 participants (estimated)
- Lead sponsor
- Hospital Universitari Vall d'Hebron Research InstituteUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Jul 2024 (estimated)
- First posted
- 13 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral + Parenteral prophylaxis + Mechanical Bowel Preparation | Experimental | 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 OralDrug: 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. |
| Oral + Parenteral prophylaxis | Active comparator | 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 IntravenousDrug: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cefuroxime (750mg) I.VExtra dosage | Drug | Oral + Parenteral prophylaxis, Oral + Parenteral prophylaxis + Mechanical Bowel Preparation |
| Colonic SurgeryColonic Surgery | Procedure or surgery | Oral + Parenteral prophylaxis, Oral + Parenteral prophylaxis + Mechanical Bowel Preparation |
| Cefuroxime 750mg oralOral prophylaxis | Drug | Oral + Parenteral prophylaxis, Oral + Parenteral prophylaxis + Mechanical Bowel Preparation |
| Metronidazole 250 MG Oral Tablet [Flagyl]Oral prophylaxis | Drug | Oral + Parenteral prophylaxis, Oral + Parenteral prophylaxis + Mechanical Bowel Preparation |
| Metronidazole 1 g IntravenousIV prophylaxis | Drug | Oral + Parenteral prophylaxis, Oral + Parenteral prophylaxis + Mechanical Bowel Preparation |
| Cefuroxime 1,5 g IntravenousIV prophylaxis | Drug | Oral + Parenteral prophylaxis, Oral + Parenteral prophylaxis + Mechanical Bowel Preparation |
| Sodium picosulfate, light magnesium oxide, anhydrous citric acid 10 mg/3.5 g/10.97 g OralLaxative for bowel cleansing | Drug | Oral + Parenteral prophylaxis + Mechanical Bowel Preparation |
Primary outcome
Rate of Wound infection
Time frame: 30 days
Superficial, deep, body-cavity This is a Clinical measure supported by image if necessary All the morbidity problems are reported independently
19 secondary outcomes
Local complications
Time frame: 30 days after surgery
Impaired healing
Time frame: 30 days after surgery
Occlusive problems
Time frame: 30 days from surgery
Nephro-urinary complications
Time frame: 30 days after surgery
Adverse events related to drugs (Harms)
Time frame: 30 days after surgery
Time to complete recovery
Time frame: 30 days after surgery
Length of Hospital stay
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 7 days
Iatrogenic problems
Time frame: 30 days after surgery
Bleeding problems
Time frame: 30 days after surgery
Cardiac complications
Time frame: 30 days after surgery
Respiratory complications
Time frame: 30 days after surgery
Neurological complications
Time frame: 30 days after surgery
Postoperative intestinal problems
Time frame: 30 days after surgery
Readmission
Time frame: 30 days after surgery
Reintervention
Time frame: 30 days after surgery
Perioperative Hypovolemia
Time frame: Intraoperative assessment
Patient satisfaction with preparation received
Time frame: within the 30 days from surgery
Death
Time frame: 30 days after surgery
Anastomotic leak
Time frame: 30 days after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2022.
- Results publication: PubMed 33872448Pellino 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.
- Derived from this study: PubMed 36748942Willis 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.
- Derived from this study: PubMed 32818460Koskenvuo 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.
- Individual participant dataSharing planned: No
Related trials for Wounds and Injuries
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Not yet recruiting
Safety Study of Microlyte DualGuard
Wound Closure, Wound Care
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
Recruiting
Effects of Cervicothoracic Mobilization in Patients With Supraspinatus Tendinitis
Rotator Cuff Tendonitis
Recruiting
MyHand-SCI: An Active Hand Orthosis for Spinal Cord Injury
Spinal Cord Injuries, Tetraplegia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eloy Espín-Basany, MD PhD study chair
Hospital Universitario Valle de Hebron, Barcelona
Gianluca Pellino, MD, PhD study director
Hospital Universitario Valle de Hebron, Barcelona
Alejandro Solís-Peña, MD, PhD study director
Hospital Universitario Valle de Hebron, Barcelona
10 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cefuroxime (750mg) I.V, Colonic Surgery and Cefuroxime 750mg oral in people with Wounds and Injuries and Surgery--Complications, run by Hospital Universitari Vall d'Hebron Research Institute at 10 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Spain, China, Greece, Italy, Russia and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eloy Espín-Basany, MD PhD (934 893 000 ext. 6587, eespin@vhebron.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Wound infection (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04161599, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2022.