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Prophylatic Effect Preoperative Antibiotics With Mechanical Bowel Preparation in SSIs

Primary Purpose

Surgical Site Infection, Postoperative Complications, Bowel Preparation

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Neomycin,metronidazole
Sponsored by
Third Affiliated Hospital, Sun Yat-Sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Surgical Site Infection focused on measuring Surgical Site Infection, oral antibiotics, mechanical bowel preparation, laparoscopic surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The Third Affiliated Hospital of Sun Yat-Sen university

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

oral antibiotics+mechanical bowel preparation

simple mechanical bowel preparation

Arm Description

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.

Only liquid diet and polyethylene glycol with 2L water was administrated orally 1 day before surgery. Enteroclysis was conduted for patients on surgical morning.

Outcomes

Primary Outcome Measures

Surgical site infection incidence
Include the superficial, deep and organ space infection.

Secondary Outcome Measures

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

Full Information

First Posted
February 25, 2019
Last Updated
April 3, 2023
Sponsor
Third Affiliated Hospital, Sun Yat-Sen University
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1. Study Identification

Unique Protocol Identification Number
NCT03856671
Brief Title
Prophylatic Effect Preoperative Antibiotics With Mechanical Bowel Preparation in SSIs
Official Title
Prophylatic Effect of Preoperative Antibiotics With Mechanical Bowel Preparation Compare With Simple Mechanical Bowel Preparation Before Laparoscopic Colorectal Surgery: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
January 17, 2019 (Actual)
Primary Completion Date
December 30, 2022 (Actual)
Study Completion Date
March 31, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Third Affiliated Hospital, Sun Yat-Sen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgical Site Infection, Postoperative Complications, Bowel Preparation, Oral Antibiotics, Colorectal Cancer
Keywords
Surgical Site Infection, oral antibiotics, mechanical bowel preparation, laparoscopic surgery

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Masking Description
No masking is to conducted in the current study.
Allocation
Randomized
Enrollment
309 (Actual)

8. Arms, Groups, and Interventions

Arm Title
oral antibiotics+mechanical bowel preparation
Arm Type
Experimental
Arm Description
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.
Arm Title
simple mechanical bowel preparation
Arm Type
No Intervention
Arm Description
Only liquid diet and polyethylene glycol with 2L water was administrated orally 1 day before surgery. Enteroclysis was conduted for patients on surgical morning.
Intervention Type
Drug
Intervention Name(s)
Neomycin,metronidazole
Intervention Description
Orally intake neomycin 1g and metronidazole 0.2g four times before surgery
Primary Outcome Measure Information:
Title
Surgical site infection incidence
Description
Include the superficial, deep and organ space infection.
Time Frame
30 days after surgery
Secondary Outcome Measure Information:
Title
Antibiotics associated complications
Description
Allergy, antibiotics associated diarrhea
Time Frame
30 days after surgery
Title
Length of hospital stay after surgery
Description
Length of hospital stay
Time Frame
30 days after surgery
Title
Bowel recovery time
Description
Time interval from surgery to flatus and defecation
Time Frame
7 days after surgery
Title
Other posteroperative complications
Description
Ilues, DVT, anastomotic fistula, hemorrhage, pulmonary infection
Time Frame
30 days after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hongbo Wei, Ph.D
Organizational Affiliation
Third Affiliated Hospital, Sun Yat-Sen University
Official's Role
Study Director
Facility Information:
Facility Name
The Third Affiliated Hospital of Sun Yat-Sen university
City
Guanzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Prophylatic Effect Preoperative Antibiotics With Mechanical Bowel Preparation in SSIs

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