Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Enchanced recovery after surgery (ERAS) protocols aim to provide safer and quicker recovery postoperatively. One of the elements in ERAS protocols is that bowel is not prepared before colorectal surgery. However, several recent retrospective register studies have suggested that mechanical bowel preparation combined to oral antibiotics before colectomy reduces complications compared to no preparation at all. This trial compares these two strategies to find out whether complications can indeed be reduced by mechanically preparing the bowel with oral antibiotics.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mechanical and oral antibiotic bowel preparation | Experimental | Mechanical bowel preparation using PEG, neomycin 2g p.o. (single-dose), and metronidazole 2g p.o. (single dose) are given the day before surgery. |
|
| No bowel preparation | No Intervention | No mechanical bowel preparation or oral antibiotics. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| neomycin, metronidazole, polyethylene glycol (PEG) | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Surgical site infection (CDC criteria) | 30 days from operation |
| Measure | Description | Time Frame |
|---|---|---|
| Comprehensive Complication Index | 30 days from operation | |
| Anastomotic dehiscence | 30 days from operation | |
| Reoperations |
| Measure | Description | Time Frame |
|---|---|---|
| 5-year overall survival | 5 years from operation | |
| 5-year disease specific survival | 5 years from operation | |
| 5-year recurrence free survival |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Helsinki University Central Hospital | Helsinki | 00029 | Finland | |||
| Central Finland Central Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31402112 | Derived | Koskenvuo L, Lehtonen T, Koskensalo S, Rasilainen S, Klintrup K, Ehrlich A, Pinta T, Scheinin T, Sallinen V. Mechanical and oral antibiotic bowel preparation versus no bowel preparation for elective colectomy (MOBILE): a multicentre, randomised, parallel, single-blinded trial. Lancet. 2019 Sep 7;394(10201):840-848. doi: 10.1016/S0140-6736(19)31269-3. Epub 2019 Aug 8. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 30 days from operation |
| Readmissions | 30 days from operation |
| Length of hospital stay | During hospital stay, anticipated 2-30 days |
| Mortality | 30- and 90-days from operation |
| Adverse effects of antibiotics (diarrhea, clostridium) | 30 days from operation |
| Patients receiving adjuvant therapy divided by patients needing adjuvant therapy | 6 months from operation |
| 5 years from operation |
| Jyväskylä |
| Finland |
| Oulu University Hospital | Oulu | Finland |
| Seinäjoki Central Hospital | Seinäjoki | Finland |
| ID | Term |
|---|---|
| D009355 | Neomycin |
| D008795 | Metronidazole |
| D011092 | Polyethylene Glycols |
| ID | Term |
|---|---|
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D009593 | Nitroimidazoles |
| D009574 | Nitro Compounds |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005026 | Ethylene Glycols |
| D006018 | Glycols |
| D000438 | Alcohols |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D001697 | Biomedical and Dental Materials |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
Not provided
Not provided