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