Prospective Randomized Clinical Trial on Oral and Intravenous Antibiotic Prophylaxis in Colorectal Surgery.

NCT04438655 | Completed DMC

• 1 other identifier: Università di TORINO
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

Elective colon surgery is considered a clean-contaminated procedure, with a Surgical Site Infection (SSI) rate not inferior to 10%. For many years the role of Mechanical Bowel Preparation (MBP) has been universally recognized as an effective measure to reduce colonic bacterial load and consequently SSI rate, mostly in European Countries. However, in the early 1970s has been demonstrated a further SSI risk reduction in colon surgery if oral non-absorbable antibiotics were added to MBP and for the next 30 years this became the standard of care prior to elective colon surgery, especially in the US. Nowadays, Meta-analyses have demonstrated that MBP does not impact upon postoperative morbidity or mortality, and as such it should not be prescribed routinely. Conversely, recent evidence has suggested that there may be a role for combined MBP and oral antibiotics, or oral antibiotics alone in the prevention of surgical site infection (SSI). The aim of this trial is to evaluate the efficacy of preoperative oral antibiotics prophylaxis for preventing surgical site infections in elective colorectal surgery.

Conditions

Colorectal Surgery

Outcome Measures

Primary Outcomes (1)

• Wound infection

  Incidence of surgical site infections (superficial or deep)

  up to 30 days after surgery

Secondary Outcomes (9)

• Perioperative complication

  up to 30 days after surgery

• Anastomotic dehiscence

  up to 30 days after surgery

• Post-operative ileus

  up to 30 days after surgery

• Extra-abdominal complications

  up to 30 days after surgery

• Readmission

  up to 30 days after surgery

Study Arms (2)

Oral + Parenteral prophylaxis

EXPERIMENTAL

Oral antibiotic drugs: \- Bimixin (Neomicin + Bacitracin tablet) 25000 UI + 2500 UI: h. 8-16-24 the day before surgery if the procedure takes place in the morning; h. 16-24-8 if the procedure takes place in the afternoon. Systemic antibiotic drugs: * Amoxicillin - Clavulanic Acid 2000/200 mg at induction of anesthesia, redosing with prolonged surgery. * in case of allergy to penicillin: Clindamycin 600 mg + Gentamycin 2 mg/kg.

Drug: Oral antibiotic drugs; Drug: Parenteral prophylaxis

Only parenteral prophylaxis

SHAM COMPARATOR

* Amoxicillin - Clavulanic Acid 2000/200 mg at induction of anesthesia, redosing with prolonged surgery. * in case of allergy to penicillin: Clindamycin 600 mg + Gentamycin 2 mg/kg.

Drug: Parenteral prophylaxis

Interventions

Oral antibiotic drugs DRUG

Oral antibiotic drugs: \- Bimixin (Neomicin + Bacitracin tablet) 25000 UI + 2500 UI: h. 8-16-24 the day before surgery if the procedure takes place in the morning; h. 16-24-8 if the procedure takes place in the afternoon.

Oral + Parenteral prophylaxis

Parenteral prophylaxis DRUG

Amoxicillin - Clavulanic Acid 2000/200 mg at induction of anesthesia, redosing with prolonged surgery. in case of allergy to penicillin: Clindamycin 600 mg + Gentamycin 2 mg/kg.

Only parenteral prophylaxis; Oral + Parenteral prophylaxis

Eligibility Criteria

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

You may qualify if:

• Summary: All consecutive patients undergoing colorectal resection should be included.
• Age: Age 18 years or above.
• The general health condition of the patient permits general anesthesia (ASA- classification I-III).
• Absence of allergy to the oral antibiotics employed
• Timing: Elective procedures.
• Technique: Open, laparoscopic, laparoscopic-assisted or laparoscopic converted to open.
• Returns to theatre: Each patient should only be included in the study once. Return to theatre during the same admission or follow up should be collected as a complication.
• Included procedures: Any colorectal resection (See Appendix B).
• Mechanical Bowel Preparation: Any mechanical bowel preparation (as indicated by each centre).

You may not qualify if:

• Emergency procedures
• Appendicectomy (unless procedure involves a right hemicolectomy)
• Primarily urological/gynecological or vascular procedure - e.g. ileal conduit, Hartmann's during ovarian surgery, resection during abdominal aortic aneurysm repair.
• Diagnostic laparotomy/laparoscopy without intestinal resection.
• Surgery involving multi-visceral surgery - e.g. pelvic exenteratio
• Controindication for mechanical preparation
• Allergy to used drugs (neomycin sulfate, amoxicillin-clavulanic acid)
• Patients who refuse to participate in the study
• Patients with intra-abdominal sepsis before surgery (abscess).
• Patients who received antibiotics for any reason within two weeks prior to surgery.
• Patients who do not comply strictly with the assigned prophylaxis regimen.
• Patients who cannot be followed at least 4 weeks after surgery.

Sponsors & Collaborators

• University of Turin, Italy: lead

Study Sites (1)

Università degli studi di Torino

Turin, Torino, 10126, Italy

Location

Related Publications (6)

• American College of Surgeons. National Surgical Quality Improvement Program Semi-annual report. 2009. Available at: https://acsnsqip.org/login/default.aspx.

  BACKGROUND

• Arriaga AF, Lancaster RT, Berry WR, Regenbogen SE, Lipsitz SR, Kaafarani HM, Elbardissi AW, Desai P, Ferzoco SJ, Bleday R, Breen E, Kastrinakis WV, Rubin MS, Gawande AA. The better colectomy project: association of evidence-based best-practice adherence rates to outcomes in colorectal surgery. Ann Surg. 2009 Oct;250(4):507-13. doi: 10.1097/SLA.0b013e3181b672bc.

  PMID: 19734778 BACKGROUND

• Csikesz NG, Nguyen LN, Tseng JF, Shah SA. Nationwide volume and mortality after elective surgery in cirrhotic patients. J Am Coll Surg. 2009 Jan;208(1):96-103. doi: 10.1016/j.jamcollsurg.2008.09.006. Epub 2008 Oct 31.

  PMID: 19228510 BACKGROUND

• Finlayson EV, Goodney PP, Birkmeyer JD. Hospital volume and operative mortality in cancer surgery: a national study. Arch Surg. 2003 Jul;138(7):721-5; discussion 726. doi: 10.1001/archsurg.138.7.721.

  PMID: 12860752 BACKGROUND

• Nichols RL, Broido P, Condon RE, Gorbach SL, Nyhus LM. Effect of preoperative neomycin-erythromycin intestinal preparation on the incidence of infectious complications following colon surgery. Ann Surg. 1973 Oct;178(4):453-62. doi: 10.1097/00000658-197310000-00008. No abstract available.

  PMID: 4743867 BACKGROUND

• Slim K, Vicaut E, Launay-Savary MV, Contant C, Chipponi J. Updated systematic review and meta-analysis of randomized clinical trials on the role of mechanical bowel preparation before colorectal surgery. Ann Surg. 2009 Feb;249(2):203-9. doi: 10.1097/SLA.0b013e318193425a.

  PMID: 19212171 BACKGROUND

MeSH Terms

Interventions

Anti-Infective Agents

Intervention Hierarchy (Ancestors)

Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Alberto Arezzo, Prof.

  University of Turin, Italy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: April 18, 2020
• First Posted: June 19, 2020
• Study Start: May 1, 2019
• Primary Completion: November 1, 2021
• Study Completion: November 1, 2021
• Last Updated: May 16, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)