Prophylatic Effect Preoperative Antibiotics With Mechanical Bowel Preparation in SSIs

Prophylatic Effect of Preoperative Antibiotics With Mechanical Bowel Preparation Compare With Simple Mechanical Bowel Preparation Before Laparoscopic Colorectal Surgery: a Randomized Controlled Trial

Surgical site infection (SSI) is a major postoperative complication after abdominal surgery especially in colorectal field, which significantly increases length of stay (LOS), readmission incidence and expense. Therefore, identification of the effective method to reduce SSI incidence is critically important. Combination of oral antibiotics and mechanical bowel preparation was reported with lower SSIs and LOS in some retrospecitve data analysis, however a prospective randmized controlled trial was absent. Herein, the current randomized controlled trial comparing MBP+OA with MBP alone in postoperative complications in order to guide clinical practise was conducted.

Study Overview

• Status: Completed
• Conditions: Postoperative Complications; Colorectal Cancer; Surgical Site Infection; Bowel Preparation; Oral Antibiotics
• Intervention / Treatment: Drug: Neomycin,metronidazole

Detailed Description

Surgical site infection (SSI) is a major postoperative complication after abdominal surgery especially in colorectal field, which significantly increases length of stay (LOS), readmission incidence and expense. Therefore, identification of the effective method to reduce SSI incidence is critically important. Colonic bacterial flora is the major cause of SSIs after elective colorectal procedures. For more than century, preoperative mechanical bowel preparation (MBP) has been utilized as it could theoretically decrease bacterial load within the surgical field, thus reduce risk of SSIs. Later afterwards with widely application of antibiotics, combination of oral antibiotics (OA) and MBP was conducted by surgeons to further decrease rates of SSIs. But SSIs still occurs despite of forehead mentioned methods, the best bowel preparation mode remains controversial. Since 2005, several RCTs and meta-analysises demonstrated MBP alone was not associated with reduced SSIs compared with no bowel preparation, while postoperative ileus, anastomotic leakage and other complications incidence increased paradoxically. Nevertheless, function of preoperative oral antibiotics remains debated. Recently, combination of oral antibiotics and MBP has been evaluated in several retrospective studies and demonstrated a significant decrease in the rate of SSIs. However, bias existence in these trials may affect result as information was exacted from national database without detailed matching. Herein, current randomized controlled trial comparing MBP+OA with MBP alone in postoperative complications in order to guide clinical practise was conducted.

• Study Type: Interventional
• Enrollment (Actual): 309
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guanzhou, Guangdong, China, 510000
      • The Third Affiliated Hospital of Sun Yat-sen University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Older than 18 years old，
• Undergoing laparoscopic colorectal surgery due to malignancy.

Exclusion Criteria:

• No elective surgery
• Intra-abdominal infection
• Combination of other infectious surgery such as appendectomy, cholecystomy
• Sever comobidity such as uncontrolled hypertention and diabetes mellitus
• Peritoneal implantation and matastasis
• Radiotherapy history.
• Colorectal surgery due to benign lesions
• Allergic to antibiotics or PEG
• Preoperative dermatosis may interfere wound healing
• Long time application of corticosteroid
• Autoimmune disease may affect wound healing
• Patients refuse to enroll

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: oral antibiotics+mechanical bowel preparation; Liquid diet and polyethylene glycol with 2L water was administrated orally 1 day before surgery. A combination of neomycin 1g and metronidazole 0.2g every 6 hours was also administrated. Enteroclysis was conduted for patients on surgical morning.	Drug: Neomycin,metronidazole; Orally intake neomycin 1g and metronidazole 0.2g four times before surgery
No Intervention: simple mechanical bowel preparation; Only liquid diet and polyethylene glycol with 2L water was administrated orally 1 day before surgery. Enteroclysis was conduted for patients on surgical morning.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Surgical site infection incidence	Include the superficial, deep and organ space infection.	30 days after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Antibiotics associated complications	Allergy, antibiotics associated diarrhea	30 days after surgery
Length of hospital stay after surgery	Length of hospital stay	30 days after surgery
Bowel recovery time	Time interval from surgery to flatus and defecation	7 days after surgery
Other posteroperative complications	Ilues, DVT, anastomotic fistula, hemorrhage, pulmonary infection	30 days after surgery

Collaborators and Investigators

• Sponsor: Third Affiliated Hospital, Sun Yat-Sen University
• Investigators: Study Director: Hongbo Wei, Ph.D, Third Affiliated Hospital, Sun Yat-Sen University

Study record dates

Study Major Dates

• Study Start (Actual): January 17, 2019
• Primary Completion (Actual): December 30, 2022
• Study Completion (Actual): March 31, 2023

Study Registration Dates

• First Submitted: February 25, 2019
• First Submitted That Met QC Criteria: February 25, 2019
• First Posted (Actual): February 27, 2019

Study Record Updates

• Last Update Posted (Actual): April 5, 2023
• Last Update Submitted That Met QC Criteria: April 3, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Surgical Site Infection; oral antibiotics; mechanical bowel preparation; laparoscopic surgery
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Wound Infection; Postoperative Complications; Surgical Wound Infection; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Anti-Bacterial Agents; Protein Synthesis Inhibitors; Antiprotozoal Agents; Antiparasitic Agents; Metronidazole; Neomycin
• Other Study ID Numbers: OAMBP-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No