Prophylatic Effect Preoperative Antibiotics With Mechanical Bowel Preparation in SSIs

NCT ID: NCT03856671

Last Updated: 2023-04-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 309 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-17
• Study Completion Date: 2023-03-31

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.

Conditions

Surgical Site Infection; Postoperative Complications; Bowel Preparation; Oral Antibiotics; Colorectal Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

oral antibiotics+mechanical bowel preparation

Liquid 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 conduted for patients on surgical morning.

Group Type: EXPERIMENTAL

Neomycin,metronidazole

Intervention Type: DRUG

Orally intake neomycin 1g and metronidazole 0.2g four times before surgery

simple mechanical bowel preparation

Only liquid diet and polyethylene glycol with 2L water was administrated orally 1 day before surgery. Enteroclysis was conduted for patients on surgical morning.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Neomycin,metronidazole

Orally intake neomycin 1g and metronidazole 0.2g four times before surgery

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Third Affiliated Hospital, Sun Yat-Sen University

OTHER

Sponsor Role: lead

Responsible Party

Hongbo Wei

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hongbo Wei, Ph.D

Role: STUDY_DIRECTOR

Third Affiliated Hospital, Sun Yat-Sen University

Locations

The Third Affiliated Hospital of Sun Yat-Sen university

Guanzhou, Guangdong, China

Countries

China

References

Lei P, Jia G, Yang X, Ruan Y, Wei B, Chen T. Region-specific protection effect of preoperative oral antibiotics combined with mechanical bowel preparation before laparoscopic colorectal resection: a prospective randomized controlled trial. Int J Surg. 2023 Oct 1;109(10):3042-3051. doi: 10.1097/JS9.0000000000000569.

Reference Type: DERIVED

PMID: 37702427 (View on PubMed)

Willis MA, Toews I, Soltau SL, Kalff JC, Meerpohl JJ, Vilz TO. Preoperative combined mechanical and oral antibiotic bowel preparation for preventing complications in elective colorectal surgery. Cochrane Database Syst Rev. 2023 Feb 7;2(2):CD014909. doi: 10.1002/14651858.CD014909.pub2.

Reference Type: DERIVED

PMID: 36748942 (View on PubMed)

Other Identifiers

OAMBP-01

Identifier Type: -

Identifier Source: org_study_id