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Prophylatic Effect Preoperative Antibiotics With Mechanical Bowel Preparation in SSIs: A Propensity Analysis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04258098
Recruitment Status : Completed
First Posted : February 6, 2020
Last Update Posted : February 6, 2020
Sponsor:
Information provided by (Responsible Party):
Hongbo Wei, Third Affiliated Hospital, Sun Yat-Sen University

Brief Summary:
Surgical site infections (SSIs) are a major postoperative complication after colorectal surgery. Current study aims to evaluate prophylactic function of oral antibiotic intake (OA) in combination with mechanical bowel preparation (MBP) relative to MBP alone with respect to postoperative SSIs incidence. A retrospective analysis of eligible patients was to conducted using the databases of the Gastrointestinal Surgery Centre, Third Affiliated Hospital of Sun Yat-sen University from 2011 to 2017. Data pertaining to postoperative hospital stay length, expenses, SSIs incidence, anastomotic fistula incidence, and rates of other complications wloud be extracted and compared. A propensity analysis was conducted to minimize bias associated with demographic characteristics.

Condition or disease Intervention/treatment
Surgical Site Infection Colorectal Cancer Drug: Oral antibiotics ( Streptomycin ,metronidazole )

Detailed Description:

Surgical site infections (SSIs) are a major postoperative complication after abdominal surgery, especially in the colorectal field. With a reported incidence of over 20%, SSIs significantly increase the length of stay (LOS), readmission rate, expenses, and mortality . Therefore, the identification of an effective method of reducing SSIs incidence is critically important.

Colonic bacterial florae are considered to be the major cause of SSIs after elective colorectal procedures, but the most effective means of decreasing this bacterial load remains under debate. Pre-operative mechanical bowel preparation (MBP) was first utilized by surgeons, as it can theoretically remove stool content and associated bacterial load within the bowel and surgical field, thus reducing risk of SSIs. More recently, as antibiotics have come to be widely utilized, the pre-operative administration of un-absorbed oral antibiotics (OA) in combination with MBP was widely conducted.

Multiple trials have been performed to explore the best bowel preparation strategies, but their results remain controversial. Since 2005, several RCTs and meta-analyses have demonstrated MBP alone was not associated with a reduced incidence of SSIs related to patients that did not undergo MBP, whereas MBP patients exhibited paradoxical increases in postoperative ileus, anastomotic leakage, and other complications. Recently, the merit of OA and MBP has been re-discovered in several related retrospective studies which demonstrated a significant decrease in the rate of SSIs.However, as information in these trials was exacted from national databases without any detailed matching between patient groups, the existence of bias in these trials may affect the validity of their results. Furthermore, none of these studies assessed the relative prophylactic effects of the novel MBP mode in right or left-side colorectal surgery.

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Study Type : Observational
Actual Enrollment : 806 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: Preoperative Mechanical Bowel Preparation With Oral Antibiotics Reduces Surgical Site Infection After Elective Colorectal Surgery for Malignancies: a Propensity Matching Analysis
Actual Study Start Date : January 1, 2011
Actual Primary Completion Date : December 31, 2017
Actual Study Completion Date : May 12, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

Group/Cohort Intervention/treatment
OA+MBP group
Either polyethylene glycol or magnesium sulphate was adopted as laxative one day before surgery. Clyster was conducted on surgery morning. Streptomycin 1g plus metronidazole 0.2g was prescribed 3 times a day for 3 days before surgery in the OA+MBP group patients.
Drug: Oral antibiotics ( Streptomycin ,metronidazole )
Either polyethylene glycol or magnesium sulphate was adopted as laxative one day before surgery. Clyster was conducted on surgery morning. Streptomycin 1g plus metronidazole 0.2g was prescribed 3 times a day for 3 days before surgery in the OA+MBP group patients.

MBP group
Either polyethylene glycol or magnesium sulphate was adopted as laxative one day before surgery. Clyster was conducted on surgery morning. No oral antibiotics was administered to the patients.



Primary Outcome Measures :
  1. SSIs incidence [ Time Frame: up to 30 days postoperatively ]
    Surgical site infection incidence


Secondary Outcome Measures :
  1. length of hospital stays [ Time Frame: up to 3 months posteroperatively ]
    length of hospital stays after colorectal surgeries



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Eligible patients were identified by searching the database of the Gastrointestinal Surgery Centre, Third Affiliated Hospital of Sun Yat-sen University from 2011 to 2017.
Criteria

Inclusion Criteria:

  1. Patient underwent elective colorectal resection to treat a malignancy;
  2. Patient baseline characteristics and operative information were available;
  3. MBP (mechanical bowel preparation) was performed before surgery, with or without OA (oral antibiotics).

Exclusion Criteria:

  1. Emergency surgery;
  2. MBP was not conducted due to ileus or patient refusal;
  3. Enough data was not available;
  4. Colorectal resection was performed due to benign disease;
  5. The procedure was accompanied by other procedures that had the potential to contaminate the incision, such as cholecystectomy or appendectomy;
  6. Patients underwent neoadjuvant radiotherapy before surgery.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Hongbo Wei, Prof., Third Affiliated Hospital, Sun Yat-Sen University
ClinicalTrials.gov Identifier: NCT04258098    
Other Study ID Numbers: OAMBP-02
2018023 ( Other Identifier: Sun Yat-sen University 5010 clinical program )
First Posted: February 6, 2020    Key Record Dates
Last Update Posted: February 6, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infection
Surgical Wound Infection
Wound Infection
Postoperative Complications
Pathologic Processes
Anti-Bacterial Agents
Metronidazole
Streptomycin
Antibiotics, Antitubercular
Magnesium Sulfate
Laxatives
Anti-Infective Agents
Antitubercular Agents
Antiprotozoal Agents
Antiparasitic Agents
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics
Central Nervous System Depressants
Anti-Arrhythmia Agents
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Tocolytic Agents
Reproductive Control Agents
Gastrointestinal Agents