Oral Antibiotic Prophylaxis in Colorectal Surgery

NCT ID: NCT03759886

Last Updated: 2020-01-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-12-17

Study Completion Date

2020-12-01

Brief Summary

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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.

Detailed Description

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Conditions

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Surgical Site Infection Anastomotic Leak

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Paromomycin Sulfate Powder

Intervention Type DRUG

The patients receive Paromomycin and Metronidazole the day prior to colorectal surgery after mechanical bowel preparation

iv Antibiotics

The patients get mechanical bowel preparation and perioperative i.v. antibiotic prophylaxis with Ertepanem 1g i.v.

No interventions assigned to this group

Interventions

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Paromomycin Sulfate Powder

The patients receive Paromomycin and Metronidazole the day prior to colorectal surgery after mechanical bowel preparation

Intervention Type DRUG

Other Intervention Names

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Metronidazole

Eligibility Criteria

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Inclusion Criteria

* all colorectal resections

Exclusion Criteria

* allergy
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Leipzig

OTHER

Sponsor Role lead

Responsible Party

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Dr. Boris Jansen-Winkeln

Consultant Colorectal Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Boris Jansen-Winkeln, PD Dr.

Role: PRINCIPAL_INVESTIGATOR

University of Leipzig

Locations

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Universitätsklinikum Leipzig - AöR

Leipzig, Saxony, Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Boris Jansen-Winkeln, PD Dr.

Role: CONTACT

+49-314-97 ext. 17200

Ines Gockel, Prof. Dr.

Role: CONTACT

References

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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.

Reference Type DERIVED
PMID: 33895874 (View on PubMed)

Other Identifiers

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ABCR

Identifier Type: -

Identifier Source: org_study_id

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