Preparation with mechanical bowel cleansing or oral antibiotics and mechanical bowel preparation for elective resection of rectum

Trial Overview

Acronym	MECCLANT-R
Number	2016-001404-32
Protocol Link	https://www.emkapes.gr/pdf/MECCLANT-protocol-rectum-new-cor-gouvas-brief.pdf
Public Trial Registry Link	https://www.emkapes-projects.eu/Apps/redcap/
Status	Open/recruiting
Category	Colorectal Cancer - Rectal Specific
Treatment Course	Surgery

Trial Description

The MECLLANT-R trial is a phase III prospective, randomized, two arm, comparative, multicenter study that aims to compare the immediate postoperative outcomes of elective rectal resections, after preoperative mechanical bowel cleansing (MBC) with or without preoperative oral antibiotics (OA) administration.

Chief Investigator

Xynos Evangelos
Professor

Profile Link

Lead Centre

Metropolitan Hospital
9 Eth Makariou & 1 El Venizelou
N Faliro
18547
Greece

Website

Collaboration and Funding

Funding Sponsors

Additional Information

Full Research Summary

Objective:	Recently, the interest in bowel preparation for colorectal surgery has been renewed, as when MBC combined with oral antibiotics seems to reduce postoperative morbidity, by preventing both anastomotic leakage and SSI, according to several clinical trials and reviews and meta-analyses. Most of the studies showing benefit for oral antibiotics bowel preparation i) are either retrospective or analyses of large databases; ii) analyze cases with varying pathology iii) are heterogeneous as regards the exact antibiotic regime iv) do not report on the exact regime for mechanical bowel preparation; v) do not analyze according to procedure and site of anastomosis vi) mostly exclude cases with anastomosis and diverting stoma; and vii) do not report on the possible impact of enhanced recovery programmes (ERP) if they were implemented.
Aim:	The present study aims to compare the immediate postoperative outcomes of elective rectal resections, after preoperative MBC with or without preoperative oral antibiotics (OA) administration.
Methods:	This is a phase III prospective, randomized, two arm, comparative, multicenter study. Participating centers register all data in a specifically designed database under the control of the DMC. Also, patients’ randomization is provided by the DMC through the online data caprturing system (REDCAP), to which serious adverse events and patients withdrawal from the study are reported.
Reason for International Trial:	Recruiting the needed number of patients.

Trial Details