Prophylatic Effect Preoperative Antibiotics With Mechanical Bowel Preparation in SSIs

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Surgical Site Infection, Postoperative Complications, Bowel Preparation, Oral Antibiotics, Colorectal Cancer

Intervention / Treatment
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* Drug: Neomycin,metronidazole


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: oral antibiotics+mechanical bowel preparation<br>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<br>* Orally intake neomycin 1g and metronidazole 0.2g four times before surgery<br>|
| No Intervention: simple mechanical bowel preparation<br>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?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Surgical Site Infection, oral antibiotics, mechanical bowel preparation, laparoscopic surgery