Clinical trial NCT03856671: Prophylatic Effect Preoperative Antibiotics With Mechanical Bowel Preparation in SSIs
Official title: Prophylatic Effect of Preoperative Antibiotics With Mechanical Bowel Preparation Compare With Simple Mechanical Bowel Preparation Before Laparoscopic Colorectal Surgery: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgical Site Infection
Postoperative Complications
Bowel Preparation
Oral Antibiotics
Colorectal Cancer
Keywords: Surgical Site Infection
oral antibiotics
mechanical bowel preparation
laparoscopic surgery
Lead sponsor: Third Affiliated Hospital, Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2019-02-27
Enrollment: 309
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Surgical site infection incidence
timeFrame: 30 days after surgery
Secondary outcomes:
measure: Antibiotics associated complications
timeFrame: 30 days after surgery
measure: Length of hospital stay after surgery
timeFrame: 30 days after surgery
measure: Bowel recovery time
timeFrame: 7 days after surgery
measure: Other posteroperative complications
timeFrame: 30 days after surgery
Other outcomes:
Locations:
city: Guanzhou
country: China
facility: The Third Affiliated Hospital of Sun Yat-Sen university
state: Guangdong
Study officials:
affiliation: Third Affiliated Hospital, Sun Yat-Sen University
name: Hongbo Wei, Ph.D
role: STUDY_DIRECTOR
References: