Oral Antibiotic Prophylaxis in Colorectal Surgery
ABCR
Mechanical Bowel Preparation and Oral Antibiotic Prophylaxis vs. Mechanical Bowel Preparation in Colorectal Surgery With i.v. Antibiotic Prophylaxis
1 other identifier
observational
100
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Dec 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 16, 2018
CompletedFirst Posted
Study publicly available on registry
November 30, 2018
CompletedStudy Start
First participant enrolled
December 17, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2020
CompletedJanuary 7, 2020
January 1, 2020
1.4 years
October 16, 2018
January 6, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Surgical Site Infections
Any kind of surgical site infection in the postoperative course.
30 days (exact 30 days after the Operation date)
Secondary Outcomes (1)
Anastomotic Leak
30 days (exact 30 days after the Operation date)
Study Arms (2)
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.
Interventions
The patients receive Paromomycin and Metronidazole the day prior to colorectal surgery after mechanical bowel preparation
Eligibility Criteria
All Patients wich receive elective colorectal surgery.
You may qualify if:
- all colorectal resections
You may not qualify if:
- allergy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Universitätsklinikum Leipzig - AöR
Leipzig, Saxony, 04103, Germany
Related Publications (1)
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.
PMID: 33895874DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Boris Jansen-Winkeln, PD Dr.
University of Leipzig
Central Study Contacts
Ines Gockel, Prof. Dr.
CONTACT
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Target Duration
- 30 Days
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Consultant Colorectal Surgery
Study Record Dates
First Submitted
October 16, 2018
First Posted
November 30, 2018
Study Start
December 17, 2018
Primary Completion
May 1, 2020
Study Completion
December 1, 2020
Last Updated
January 7, 2020
Record last verified: 2020-01