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NCT Number: NCT03856671

Prophylatic Effect Preoperative Antibiotics With Mechanical Bowel Preparation in SSIs

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Neomycin,metronidazole

Drug

Orally intake neomycin 1g and metronidazole 0.2g four times before surgery

Primary outcomes

  1. Surgical site infection incidence

    Time frame: 30 days after surgery

    Include the superficial, deep and organ space infection.

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Third Affiliated Hospital, Sun Yat-Sen University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2022
Study completion
2023
First posted
Feb 27, 2019
Registry last updated
Apr 5, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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