Preparation with mechanical bowel cleansing and oral antibiotics or nothing for elective colectomy

Trial Overview

Acronym	MECCLANT-C
Number	2016-000254-35
Protocol Link	https://www.emkapes.gr/pdf/MECCLANT-protocol-colon-new-cor-gouvas-brief.pdf
Public Trial Registry Link	https://www.emkapes-projects.eu/Apps/redcap/
Status	Open/recruiting
Category	Colorectal Cancer - Colonic Specific
Treatment Course	Surgery

Trial Description

The MECCLANT-C trial is a phase II prospective, randomized, two-arm, comparative, multicenter study supported by the Gastro-Intestinal Cancer Srudy Group (GIC-SG). Patients are allocated in two groups: no bowel preparation and mechanical bowel cleansing plus oral antibiotics. Primary end points: Incisional surgical site infection and Secondary end points: anastomotic leakage, 30-day mortality, 30-day morbidity, paralytic ileus, length of hospital stay, radmission rate.

Chief Investigator

Xynos Evangelos
Professor

Profile Link

Lead Centre

Gastro-Intestinal Cancer Study Group
19 Michelidaki str
Herakleion
71202
Greece

Website

Collaboration and Funding

Funding Sponsors

Additional Information

Full Research Summary

Objective:	Recently the interest on bowel preparation for colorectal surgery has been renewed as the results of several trials have shown that mechanical bowel cleansing (MBC) combined with oral antibiotics seem to reduce postoperative morbidity.
Aim:	The present study aims to compare the immediate postoperative outcomes of elective colectomy for colon cancer, after no preoperative preparation or after preoperative preparation with MBC and oral antibiotics administration.
Methods:	A phase III prospective, randomized, two arm, comparative, multicenter study. Participating centers register all data in e specifically designed database under the control of the DMC. Also randomization of patients is provided by the DMC, to which any serious adverse events or patients withdrawal from the study are reported.
Reason for International Trial:	increase recruitment

Trial Details