Preparation with Mechanical Bowel Cleansing or/and Oral Antibiotics or Nothing for Elective Colorectal Surgery: Two-Two-Arm Multicentre Randomised Controlled Studies (MECCLANT –C and –R Trials)
Journal Title: UNKNOWN - Year 2017, Vol 7, Issue 2
Abstract
Background: Based on sound evidence, traditional mechanical bowel preparation for elective colorectal surgery has mostly been abandoned during the last two decades. However, more recent evidence from USA large databases show that mechanical bowel preparation combined with oral antibiotics, reduces significantly surgical site infections (SSI) after elective colorectal surgery. Hypothesis-Aim: We hypothesise that administration of oral antibiotics only, and not mechanical bowel preparation, is the main factor that prevents SSI. Furthermore, we consider that rectal surgery for cancer differs from colon surgery in that the former is usually associated with defunctioning stoma, which requires an empty colon. Patients-Methods: Patients to be subjected to elective colectomy for colonic neoplasms or diverticular disease will be randomised to two arms; Arm A: no bowel preparation; Arm B: mechanical bowel preparation combined with oral antibiotics (MECCLAND –C Trial). Patients scheduled for elective low anterior resection of the rectum for rectal cancer will be randomised to two arms; Arm A: mechanical bowel preparation only; Arm B: mechanical bowel preparation combined with oral antibiotics (MECCLAND –R Trial). All patients will receive intravenous antibiotics one hour prior to first surgical incision. Enemas at the day prior to surgery are optional. Participating centres are advised to implement enhanced recovery programmes in all patients. Primary End-Points: The primary end point is surgical site infection (SSI), including (i) superficial wound infection, (ii) deep wound infection, and (iii) intrabdominal infection (contaminated fluid or pus collection). Statistical Points: Considering a SSI rate of 0.12 for Arm A vs. a SSI rate of 0.06 for Arm B, a randomization rate of 1:1 and negligible drop-off rate, the sample size of either Arm of either Trial should be 356 patients.
Authors and Affiliations
Nikolaos Gouvas
Keywords
Related Articles
- EP ID EP382375
- DOI 10.4172/2167-0870.1000300
- Views 58
- Downloads 0
Medicine Development Needs Radical Reform: Commentary
Medicines are a vital and an expensive component of health care. The present situation with regard both to the development and licensing of medicines, and to their pricing and supply are in a state that damages the provi...
Pre-Senile Cataract in Diabetic Patients: Prevalence and Early Diagnosis
Hypothesis: Since cataract is more prevalent in the diabetic population, the authors compared the findings of the gold standard Lens Opacity Classification System III (LOCSIII) with the Scheimpflug objective measures in...
Management of Pleural Effusion by Combining Talc Poudrage and Indwelling Pleural Catheter: A Retrospective Single Center Study
Objective: In 2013 we started to combine VATS poudrage with simultaneous insertion of an indwelling pleural catheter (IPC) for management of malignant pleural effusions (MPE) to achieve successful pleurodesis, avoid recu...
Nivolumab Maintenance as Monotherapy after Carboplatin Plus Nab- Paclitaxel for First-Line Treatment of Advanced Non-Small-Cell Lung Cancer: Study Protocol for Feasibility
The aim of this study is to determine the feasibility of nivolumab as maintenance therapy after first-line chemotherapy with carboplatin plus nab-paclitaxel in non-small-cell lung cancer. Since we cannot change the dose...
The ANQueSt (Asian Nurse Quality of life Study) to Compare Quality of Life and Identify Related Variables: Study Protocol for a Cross-Sectional Design
Background: Hospital-based nurses’ quality of life is affected by stress coping ability, job satisfaction, job stress, and social support. These relationships appear to be identical, even among different countries. Never...