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The investigators perform a case-control study to compare preparation before elective colorectal surgery. The first group is a prospective patient - registry in all patients with mechanical bowel preparation (MBP) and oral antibiotic prophylaxis the day before colorectal surgery. The second group is a historic collective of patients with MBP only and colorectal surgery. The cases were matches in American Society of Anesthesiologists (ASA) physical status classification system, BMI, operative procedure and risk factors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral Antibiotics | The patients get mechanical bowel preparation and oral antibiotic prophylaxis with 4g Paromomycin (Paromomycin Sulfate Powder) and 1 g Metronidazole p.o. and perioperative i.v. antibiotic prophylaxis with Ertepanem 1g i.v. |
| |
| iv Antibiotics | The patients get mechanical bowel preparation and perioperative i.v. antibiotic prophylaxis with Ertepanem 1g i.v. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paromomycin Sulfate Powder | Drug | The patients receive Paromomycin and Metronidazole the day prior to colorectal surgery after mechanical bowel preparation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Surgical Site Infections | Any kind of surgical site infection in the postoperative course. | 30 days (exact 30 days after the Operation date) |
| Measure | Description | Time Frame |
|---|---|---|
| Anastomotic Leak | All with objective methods proven anastomotic leakage (like contrast enema, re-operation or endoscopy) | 30 days (exact 30 days after the Operation date) |
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Inclusion Criteria:
Exclusion Criteria:
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All Patients wich receive elective colorectal surgery.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Boris Jansen-Winkeln, PD Dr. | Contact | +49-314-97 | 17200 | boris.jansen-winkeln@medizin.uni-leipzig.de |
| Ines Gockel, Prof. Dr. | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Boris Jansen-Winkeln, PD Dr. | University of Leipzig | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitätsklinikum Leipzig - AöR | Recruiting | Leipzig | Saxony | 04103 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33895874 | Derived | Mehdorn M, Lubbert C, Chaberny IF, Gockel I, Jansen-Winkeln B. Mechanical plus oral bowel preparation with paromomycin and metronidazole reduces infectious complications in elective colorectal surgery: a matched case-control study. Int J Colorectal Dis. 2021 Sep;36(9):1839-1849. doi: 10.1007/s00384-021-03931-9. Epub 2021 Apr 25. |
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| ID | Term |
|---|---|
| D013530 | Surgical Wound Infection |
| D057868 | Anastomotic Leak |
| ID | Term |
|---|---|
| D014946 | Wound Infection |
| D007239 | Infections |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D008795 | Metronidazole |
| ID | Term |
|---|---|
| D009593 | Nitroimidazoles |
| D009574 | Nitro Compounds |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
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|
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D001393 |
| Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |