drugset / Trial / NCT04161599
Preoperative Oral Antibiotics With vs Without Mechanical Bowel Preparation to Reduce Surgical Site Infections Following Colonic Resection: an International Randomized Controlled Trial.
RandomizedParallel-groupSingle-blindPrevention
Summary
The ORALEV Study found that preoperative oral antibiotics can reduce the incidence of surgical site infections after colonic resection, compared with no preparation. The role of mechanical bowel preparation in patients needing colonic surgery is yet to be elucidated. No randomised controlled trials have assessed the impact of mechanical bowel preparation combined with oral antibiotics on the incidence of surgical site infections after colonic surgery, compared with oral antibiotics only.
Timeline
- Start
- 2022-03-01
- Primary completion
- 2024-06
- Completion
- 2024-07
Publications
- Results Pellino G, Solis-Pena A, Kraft M, Huguet BM, Espin-Basany E. Preoperative oral antibiotics with versus without mechanical bowel preparation to reduce surgical site infections following colonic resection: Protocol for an international randomized controlled trial (ORALEV2). Colorectal Dis. 2021 Aug;23(8):2173-2181. doi: 10.1111/codi.15681. Epub 2021 May 12.
- 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.
- Koskenvuo L, Sallinen V. Preoperative oral antibiotics in colon surgery. Lancet Gastroenterol Hepatol. 2020 Sep;5(9):801-802. doi: 10.1016/S2468-1253(20)30203-X. No abstract available.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Magnesium Oxide | Small molecule | 3.5 g | Oral |
| Subject | Sodium Picosulfate | Unknown | 10 mg | Oral |
| Subject | citric acid | Unknown | 10.97 g | Oral |
| Background | Cefuroxime | Small molecule | 750 mg | Intravenous |
| Background | Cefuroxime | Small molecule | 1.5 g | Intravenous |
| Background | Metronidazole | Small molecule | 250 mg | Oral |
| Background | Metronidazole | Small molecule | 1 g | Oral |
Indications
No indication recorded.