The Third Affiliated Hospital of Sun Yat-Sen university
Guanzhou, Guangdong, 510000, China
NCT Number: NCT03856671
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.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Not applicable
Guanzhou, Guangdong, 510000, China
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Orally intake neomycin 1g and metronidazole 0.2g four times before surgery
Time frame: 30 days after surgery
Include the superficial, deep and organ space infection.
Time frame: 30 days after surgery
Allergy, antibiotics associated diarrhea
Time frame: 30 days after surgery
Length of hospital stay
Time frame: 7 days after surgery
Time interval from surgery to flatus and defecation
Time frame: 30 days after surgery
Ilues, DVT, anastomotic fistula, hemorrhage, pulmonary infection
Third Affiliated Hospital, Sun Yat-Sen University
Other
Prophylatic Effect of Preoperative Antibiotics With Mechanical Bowel Preparation Compare With Simple Mechanical Bowel Preparation Before Laparoscopic Colorectal Surgery: a Randomized Controlled Trial
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.
Published trials that share one or more normalized conditions with this study.
NCT03598413
Atrophy, Colonic Diseases
Guildford, Surrey, United Kingdom
View Trial DetailsNCT07360691
Abdominal Wall Hernia, Hernia
Mandya, Karnataka, India
View Trial DetailsNCT06549803
Colonic Diseases, Colorectal Cancer
Seoul, Seocho, South Korea
View Trial DetailsNCT05399186
Behavior, Infections
Reykjavik, Hringbraut, Iceland
View Trial Details