Prophylatic Effect Preoperative Antibiotics With Mechanical Bowel Preparation in SSIs

Colorectal Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03856671
• Other study ID #: OAMBP-01
• Status: Completed
• Phase: N/A
• Start date: January 17, 2019
• Est. completion date: March 31, 2023

Study information

• Verified date: April 2023
• Source: Third Affiliated Hospital, Sun Yat-Sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 309
• Est. completion date: March 31, 2023
• Est. primary completion date: December 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bowel Preparation
• Colorectal Cancer
• Oral Antibiotics
• Postoperative Complications
• Surgical Site Infection
• Surgical Wound Infection

Intervention

Drug:
• Neomycin,metronidazole
Orally intake neomycin 1g and metronidazole 0.2g four times before surgery

Locations

Country	Name	City	State
China	The Third Affiliated Hospital of Sun Yat-Sen university	Guanzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Third Affiliated Hospital, Sun Yat-Sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Surgical site infection incidence	Include the superficial, deep and organ space infection.	30 days after surgery
Secondary	Antibiotics associated complications	Allergy, antibiotics associated diarrhea	30 days after surgery
Secondary	Length of hospital stay after surgery	Length of hospital stay	30 days after surgery
Secondary	Bowel recovery time	Time interval from surgery to flatus and defecation	7 days after surgery
Secondary	Other posteroperative complications	Ilues, DVT, anastomotic fistula, hemorrhage, pulmonary infection	30 days after surgery