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
| 1. Gasto Intestinal Cancer - Study Group |
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. |