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. 2023 Feb 7;2023(2):CD014909. doi: 10.1002/14651858.CD014909.pub2

NCT03856671.

Study name Prophylactic Effect Preoperative Antibiotics With Mechanical Bowel Preparation in SSIs
Methods Study type: interventional
Study design
  • Allocation: randomised

  • Intervention Model: parallel assignment

  • Masking d: no masking is to be conducted in the current study

  • Primary purpose: prevention

Participants Condition or disease: Surgical Site Infection, Postoperative Complications, Bowel Preparation, Oral Antibiotics, Colorectal Cancer
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 comorbidity such as uncontrolled hypertension and diabetes mellitus

  • Peritoneal implantation and metastasis

  • 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 enrol


Target sample size: 360
Interventions Treatment arms
  • Experimental: oral antibiotics+mechanical bowel preparationLiquid 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 conducted for patients on surgical morning.

  • No Intervention: simple mechanical bowel preparation. Only liquid diet and polyethylene glycol with 2L water was administrated orally 1 day before surgery. Enteroclysis was conducted for patients on surgical morning.

Outcomes Primary outcome
  • Surgical site infection incidence [Time Frame: 30 days after surgery]


Secondary outcomes
  • Antibiotics associated complications [Time Frame: 30 days after surgery]

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

  • Bowel recovery time [Time Frame: 7 days after surgery]

  • Other postoperative complications [Time Frame: 30 days after surgery]

Starting date Date of registration: February 27, 2019
Actual Study Start Date: January 17, 2019
Estimated Primary Completion Date: June 30, 2021 (Last Update Posted: February 5, 2020)
Recruitment Status: Recruiting (Last Update Posted: February 5, 2020)
Contact information Contact person: Purun Lei
Affiliation: The Third Affiliated Hospital of Sun Yat‐Sen university
Country of origin: China
Notes Ethics approval:
Source of funding: