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Trial record 8 of 59 for:    Neomycin sulfate

Prophylatic Effect Preoperative Antibiotics With Mechanical Bowel Preparation in SSIs

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ClinicalTrials.gov Identifier: NCT03856671
Recruitment Status : Recruiting
First Posted : February 27, 2019
Last Update Posted : May 20, 2019
Sponsor:
Information provided by (Responsible Party):
Hongbo Wei, 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.

Condition or disease Intervention/treatment Phase
Surgical Site Infection Postoperative Complications Bowel Preparation Oral Antibiotics Colorectal Cancer Drug: Neomycin,metronidazole Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 360 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Masking Description: No masking is to conducted in the current study.
Primary Purpose: Prevention
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
Estimated Study Start Date : May 17, 2019
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : October 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

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.



Primary Outcome Measures :
  1. Surgical site infection incidence [ Time Frame: 30 days after surgery ]
    Include the superficial, deep and organ space infection.


Secondary Outcome Measures :
  1. Antibiotics associated complications [ Time Frame: 30 days after surgery ]
    Allergy, antibiotics associated diarrhea

  2. Length of hospital stay after surgery [ Time Frame: 30 days after surgery ]
    Length of hospital stay

  3. Bowel recovery time [ Time Frame: 7 days after surgery ]
    Time interval from surgery to flatus and defecation

  4. Other posteroperative complications [ Time Frame: 30 days after surgery ]
    Ilues, DVT, anastomotic fistula, hemorrhage, pulmonary infection



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03856671


Contacts
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Contact: Purun Lei, M.D (86)20-85252228 leipurun@163.com

Locations
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China, Guangdong
The Third Affiliated Hospital of Sun Yat-Sen university Recruiting
Guanzhou, Guangdong, China, 510000
Contact: Purun Lei, M.D    (86)20-85252225    leipurun@163.com   
Sponsors and Collaborators
Third Affiliated Hospital, Sun Yat-Sen University
Investigators
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Study Director: Hongbo Wei, Ph.D Third Affiliated Hospital, Sun Yat-Sen University

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Responsible Party: Hongbo Wei, Professor, Third Affiliated Hospital, Sun Yat-Sen University
ClinicalTrials.gov Identifier: NCT03856671     History of Changes
Other Study ID Numbers: OAMBP-01
First Posted: February 27, 2019    Key Record Dates
Last Update Posted: May 20, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hongbo Wei, Third Affiliated Hospital, Sun Yat-Sen University:
Surgical Site Infection
oral antibiotics
mechanical bowel preparation
laparoscopic surgery
Additional relevant MeSH terms:
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Neomycin
Surgical Wound Infection
Postoperative Complications
Infection
Pathologic Processes
Wound Infection
Anti-Bacterial Agents
Metronidazole
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents
Antiprotozoal Agents
Antiparasitic Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action