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Prophylatic Effect Preoperative Antibiotics With Mechanical Bowel Preparation in SSIs

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03856671
Enrollment
309
Registered
2019-02-27
Start date
2019-01-17
Completion date
2023-03-31
Last updated
2023-04-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Surgical Site Infection, oral antibiotics, mechanical bowel preparation, laparoscopic surgery

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.

Interventions

DRUGNeomycin,metronidazole

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

Sponsors

Third Affiliated Hospital, Sun Yat-Sen University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Masking description

No masking is to conducted in the current study.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Surgical site infection incidence30 days after surgeryInclude the superficial, deep and organ space infection.

Secondary

MeasureTime frameDescription
Antibiotics associated complications30 days after surgeryAllergy, antibiotics associated diarrhea
Length of hospital stay after surgery30 days after surgeryLength of hospital stay
Bowel recovery time7 days after surgeryTime interval from surgery to flatus and defecation
Other posteroperative complications30 days after surgeryIlues, DVT, anastomotic fistula, hemorrhage, pulmonary infection

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 28, 2026