NCT03856671

Prophylatic Effect Preoperative Antibiotics With Mechanical Bowel Preparation in SSIs

Completed NA Last updated 5 April 2023

What this trial tests

NA trial testing Neomycin,metronidazole in Surgical Site Infection in 309 participants. Completed in 31 March 2023.

Timeline

17 January 2019

Primary endpoint
30 December 2022

31 March 2023

Quick facts

Lead sponsor	Third Affiliated Hospital, Sun Yat-Sen University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	309
Start date	17 January 2019
Primary completion	30 December 2022
Estimated completion	31 March 2023
Sites	1 location across China

Drugs / interventions tested

• Neomycin,metronidazole — full drug profile →

Conditions studied

• Surgical Site Infection — all drugs for Surgical Site Infection →
• Postoperative Complications — all drugs for Postoperative Complications →
• Bowel Preparation — all drugs for Bowel Preparation →
• Oral Antibiotics — all drugs for Oral Antibiotics →

Sponsor

Third Affiliated Hospital, Sun Yat-Sen University

Who can join

18 and older, any sex, with Surgical Site Infection or Postoperative Complications. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own 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. 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.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. Preoperative combined mechanical and oral antibiotic bowel preparation for preventing complications in elective colorectal surgery.
   Willis MA, Toews I, Soltau SL, Kalff JC, et al · · 2023 · cited 46× · PMID 36748942 · DOI 10.1002/14651858.cd014909.pub2
2. Preoperative mechanical bowel preparation with oral antibiotics reduces surgical site infection after elective colorectal surgery for malignancies: results of a propensity matching analysis.
   Lei P, Ruan Y, Yang X, Wu J, et al · · 2020 · cited 12× · PMID 32046725 · DOI 10.1186/s12957-020-1804-4
3. Bidirectional effects of intestinal microbiota and antibiotics: a new strategy for colorectal cancer treatment and prevention.
   Zhang W, Zhang J, Liu T, Xing J, et al · · 2022 · cited 10× · PMID 35661254 · DOI 10.1007/s00432-022-04081-3
4. Region-specific protection effect of preoperative oral antibiotics combined with mechanical bowel preparation before laparoscopic colorectal resection: a prospective randomized controlled trial.
   Lei P, Jia G, Yang X, Ruan Y, et al · · 2023 · cited 8× · PMID 37702427 · DOI 10.1097/js9.0000000000000569
5. Antimicrobial approach of abdominal post-surgical infections.
   Fiore M, Corrente A, Di Franco S, Alfieri A, et al · · 2023 · cited 6× · PMID 38222012 · DOI 10.4240/wjgs.v15.i12.2674
6. Risk factors analysis for surgical site infection following elective colorectal resection: a retrospective regression analysis.
   Lei PR, Liao JW, Ruan Y, Yang XF, et al · · 2020 · cited 6× · PMID 31996547 · DOI 10.1097/cm9.0000000000000670