Clinical trial

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

Name
OAMBP-01
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. 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.
Trial arms
Trial start
2019-01-17
Estimated PCD
2022-12-30
Trial end
2023-03-31
Status
Completed
Treatment
Neomycin,metronidazole
Orally intake neomycin 1g and metronidazole 0.2g four times before surgery
Arms:
oral antibiotics+mechanical bowel preparation
Size
309
Primary endpoint
Surgical site infection incidence
30 days after surgery
Eligibility 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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'No masking is to conducted in the current study.'}}, 'enrollmentInfo': {'count': 309, 'type': 'ACTUAL'}}
Updated at
2023-04-05

1 organization

1 product

5 indications

Indication
SSIs