Prophylatic Effect Preoperative Antibiotics With Mechanical Bowel Preparation in SSIs

Not Applicable

Completed

• Conditions: Oral Antibiotics; Postoperative Complications; Surgical Site Infection; Colorectal Cancer; Bowel Preparation
• Interventions: Drug: Neomycin,metronidazole

• Registration Number: NCT03856671
• Lead Sponsor: Third Affiliated Hospital, Sun Yat-Sen University

Brief Summary

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.

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 Timeline

• Study Start: 2019-01-17
• Study First Submitted: 2019-02-25
• Study First Submitted QC: 2019-02-25
• Study First Posted: 2019-02-27
• Primary Completion: 2022-12-30
• Study Completion: 2023-03-31
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-03
• Last Update Posted: 2023-04-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 309

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
oral antibiotics+mechanical bowel preparation	Neomycin,metronidazole	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.

Primary Outcome Measures

Name	Time	Method
Surgical site infection incidence	30 days after surgery	Include the superficial, deep and organ space infection.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

The Third Affiliated Hospital of Sun Yat-Sen university; 🇨🇳 Guanzhou, Guangdong, China