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
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Participants |
Condition or disease: Surgical Site Infection, Postoperative Complications, Bowel Preparation, Oral Antibiotics, Colorectal Cancer Inclusion criteria
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.
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Outcomes |
Primary outcome
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]
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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: ‐ |