Preoperative oral antibiotics with vs without mechanical bowel preparation to reduce surgical site infections following colonic resection: protocol for an International randomized controlled trial (ORALEV2)

2021 ◽  
Author(s):  
Gianluca Pellino ◽  
Alejandro Solís‐Peña ◽  
Miquel Kraft ◽  
Bernat Miguel Huguet ◽  
Eloy Espín‐Basany
Keyword(s):  
Randomized Controlled Trial ◽  
Bowel Preparation ◽  
Controlled Trial ◽  
Mechanical Bowel Preparation ◽  
Surgical Site Infections ◽  
Colonic Resection ◽  
Oral Antibiotics ◽  
Randomized Controlled

Randomized controlled trial of mechanical bowel preparation for laparoscopy‐assisted colectomy

2018 ◽  
Vol 12 (4) ◽  
pp. 408-411
Author(s):  
Anh T Mai‐Phan ◽  
Hai Nguyen ◽  
Tin T Nguyen ◽  
Dung A Nguyen ◽  
Truc T Thai
Keyword(s):  
Randomized Controlled Trial ◽  
Bowel Preparation ◽  
Controlled Trial ◽  
Mechanical Bowel Preparation ◽  
Randomized Controlled

scholarly journals Mechanical Bowel Preparation before Laparoscopic Hysterectomy: A Randomized Controlled Trial

2013 ◽  
Vol 20 (6) ◽  
pp. S11
Author(s):  
M.T. Siedhoff ◽  
L.H. Clark ◽  
A.D. Findley ◽  
K.A. Hobbs ◽  
E.T. Carey
Keyword(s):  
Randomized Controlled Trial ◽  
Bowel Preparation ◽  
Controlled Trial ◽  
Mechanical Bowel Preparation ◽  
Laparoscopic Hysterectomy ◽  
Randomized Controlled

scholarly journals 1: Post-operative prophylactic oral antibiotics for preventing surgical site infections in obese women undergoing cesarean deliveries: A randomized controlled trial

2017 ◽  
Vol 216 (1) ◽  
pp. S2
Author(s):  
Amy M. Valent ◽  
Carri R. Warshak ◽  
Chris DeArmond ◽  
Judy Houston ◽  
Srinidhi Reddy ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Surgical Site Infections ◽  
Obese Women ◽  
Oral Antibiotics ◽  
Randomized Controlled ◽  
Cesarean Deliveries

scholarly journals Are preoperative oral antibiotics effective in reducing the incidence of anastomotic leakage after Colorectal cancer surgery: Study protocol for a prospective, multicentre, randomized controlled study

2021 ◽  
Author(s):  
Rui Qi Gao ◽  
WeiDong Wang ◽  
PengFei Yu ◽  
ZhenChang Mo ◽  
DanSheng Dong ◽  
...  
Keyword(s):  
Anastomotic Leakage ◽  
Bowel Preparation ◽  
Mechanical Bowel Preparation ◽  
Surgical Site Infections ◽  
Colon Surgery ◽  
Ethics Committee ◽  
Oral Antibiotics ◽  
Colorectal Cancer Surgery ◽  
Randomized Controlled ◽  
Intestinal Preparation

Abstract Introduction The optimal preoperative preparation for elective colorectal cancer surgery has been debated in academic circles for decades. Previously, many expert teams have conducted studies on whether preoperative mechanical bowel preparation and preoperative oral antibiotics can effectively reduce the incidence of postoperative complications, such as surgical site infections and anastomotic leakage. Most of the results of these studies have suggested that preoperative mechanical bowel preparation for elective colon surgery has no significant effect on the occurrence of surgical site infections and anastomotic leakage. Methods/design This study will examine whether oral antibiotic bowel preparation (OABP) influences the incidence of anastomotic leakage after surgery in a prospective, multicentre, randomized controlled trial that will enrol 1500 patients who need colon surgery. The primary endpoint, incidence of anastomotic leakage, is based on 2.3% in the OABP ± mechanical bowel preparation (MBP) group in the study by Morris et al. The patients will be randomized (1:1) into two groups: the test group will be given antibiotics (both neomycin 1 g and metronidazole 1 g) the day before surgery, and the control group will not have any special intestinal preparation before surgery, including oral antibiotics or mechanical intestinal preparation. All study-related clinical data, such as general patient information, past medical history, laboratory examination, imaging results, and surgery details, will be recorded before surgery and during the time of hospitalization. The occurrence of postoperative fistulas, including anastomotic leakage, will be recorded as the main severe postoperative adverse event and will represent the primary endpoint. Ethics and dissemination Ethics and dissemination Ethics approval has been obtained from the Ethics Committee at the Chinese Ethics Committee of Registering Clinical Trials(ChiECRCT20200173). The results of this study will be disseminated at several research conferences and as published articles in peer-reviewed journals. Trial registration: ChiCTR2000035550. Registered on 13 Aug 2020.

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