Prophylatic Effect Preoperative Antibiotics With Mechanical Bowel Preparation in SSIs

NCT03856671 | Completed

• 1 other identifier: OAMBP-01
• Study Type: interventional
• Target: 309
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Surgical Site Infection; oral antibiotics; mechanical bowel preparation; laparoscopic surgery

Outcome Measures

Primary Outcomes (1)

• Surgical site infection incidence

  Include the superficial, deep and organ space infection.

  30 days after surgery

Secondary Outcomes (4)

• Antibiotics associated complications

  30 days after surgery

• Length of hospital stay after surgery

  30 days after surgery

• Bowel recovery time

  7 days after surgery

• Other posteroperative complications

  30 days after surgery

Study Arms (2)

oral antibiotics+mechanical bowel preparation

EXPERIMENTAL

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.

Drug: Neomycin,metronidazole

simple mechanical bowel preparation

NO INTERVENTION

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

Interventions

Neomycin,metronidazole DRUG

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

oral antibiotics+mechanical bowel preparation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Older than 18 years old，
• Undergoing laparoscopic colorectal surgery due to malignancy.

You may not qualify if:

• 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

Sponsors & Collaborators

• Third Affiliated Hospital, Sun Yat-Sen University: lead

Study Sites (1)

The Third Affiliated Hospital of Sun Yat-Sen university

Guanzhou, Guangdong, 510000, China

Location

Related Publications (2)

• 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.

  PMID: 37702427 DERIVED

• 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.

  PMID: 36748942 DERIVED

MeSH Terms

Conditions

Surgical Wound Infection; Postoperative Complications; Colorectal Neoplasms

Interventions

Neomycin; Metronidazole

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Aminoglycosides; Glycosides; Carbohydrates; Nitroimidazoles; Nitro Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Hongbo Wei, Ph.D

  Third Affiliated Hospital, Sun Yat-Sen University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: No masking is to conducted in the current study.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 25, 2019
• First Posted: February 27, 2019
• Study Start: January 17, 2019
• Primary Completion: December 30, 2022
• Study Completion: March 31, 2023
• Last Updated: April 5, 2023

Record last verified: 2023-04

Locations

CN (1)