Surgical Site InfectionABCRNCT03759886
Oral Antibiotic Prophylaxis in Colorectal Surgery
An observational study of Surgical Site Infection and Anastomotic Leak, run by University of Leipzig at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgical Site Infection, Anastomotic Leak
- What is being tested?
- Paromomycin Sulfate Powder
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- 17 Dec 2018to 1 Dec 2020
- How long will I take part?
- 30 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All Patients wich receive elective colorectal surgery.
Who may be able to join
- all colorectal resections
Who cannot join
- allergy
Trial locations and contacts
1 site in 1 country.
Boris Jansen-Winkeln, PD Dr. contact
Ines Gockel, Prof. Dr. contact
Germany1 site, 1 recruiting
- Recruiting
Universitätsklinikum Leipzig - AöR
Leipzig, Saxony, 04103
About this study
Official title: Mechanical Bowel Preparation and Oral Antibiotic Prophylaxis vs. Mechanical Bowel Preparation in Colorectal Surgery With i.v. Antibiotic Prophylaxis
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.
- Conditions
- Surgical Site Infection, Anastomotic Leak
- Being tested
- Paromomycin Sulfate Powder
- Medical subject headings
- Surgical Wound Infection, Anastomotic Leak
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paromomycin Sulfate PowderDrug
Also called Metronidazole
The patients receive Paromomycin and Metronidazole the day prior to colorectal surgery after mechanical bowel preparation
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Paromomycin Sulfate Powder | |
| iv Antibiotics | The patients get mechanical bowel preparation and perioperative i.v. antibiotic prophylaxis with Ertepanem 1g i.v. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical Site Infections
Any kind of surgical site infection in the postoperative course.
Measured: 30 days (exact 30 days after the Operation date)
Secondary outcomes (1)
Anastomotic Leak
All with objective methods proven anastomotic leakage (like contrast enema, re-operation or endoscopy)
Measured: 30 days (exact 30 days after the Operation date)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2018
- Study start17 Dec 2018
- Primary completion1 May 2020 (estimated)
- Study completion1 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Surgical Site InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- University of Leipzig
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Boris Jansen-Winkeln, University of Leipzig
- Investigators
- Boris Jansen-Winkeln, PD Dr., Principal investigator, University of Leipzig
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03759886
- Sponsor's protocol ID
- ABCR
- Acronym
- ABCR
- Status last verified
- Jan 2020
- First submitted
- 16 Oct 2018
- Last updated
- 7 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 33895874
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanical Bowel Preparation and Oral Antibiotic Prophylaxis vs. Mechanical Bowel Preparation in Colorectal Surgery With i.v. Antibiotic Prophylaxis
- ClinicalTrials.gov ID
- NCT03759886
- Acronym / sponsor ID
- ABCR / ABCR
- Conditions
- Surgical Site Infection, Anastomotic Leak
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of LeipzigUniversity, hospital or other
- Study start
- 17 Dec 2018 (actual)
- Primary completion
- 1 May 2020 (estimated)
- Study completion
- 1 Dec 2020 (estimated)
- First posted
- 30 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 30 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral Antibiotics | – | Drug: Paromomycin Sulfate PowderThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All Patients wich receive elective colorectal surgery.
Key inclusion criteria (1 listed)
- all colorectal resections
Key exclusion criteria (1 listed)
- allergy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Paromomycin Sulfate PowderAlso: MetronidazoleThe patients receive Paromomycin and Metronidazole the day prior to colorectal surgery after mechanical bowel preparation | Drug | Oral Antibiotics |
Primary outcome
Surgical Site Infections
Time frame: 30 days (exact 30 days after the Operation date)
Any kind of surgical site infection in the postoperative course.
1 secondary outcome
Anastomotic Leak
Time frame: 30 days (exact 30 days after the Operation date)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2020.
- Derived from this study: PubMed 33895874Mehdorn 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.
- Individual participant dataSharing planned: Undecided
Related trials for Surgical Site Infection
Not yet recruitingObservational study
Arterial Stiffness During Negative Pressure Wound Therapy for Abdominal Wall Wounds
Postoperative Abdominal Wall Wound Complications, Surgical Wound Infection
Not yet recruiting
Povidone-Iodine and Ozonated Distilled Water Irrigation in the Management of Maxillofacial Space Infections
Infection, Surgical Site
Not yet recruiting
Suture Choice for Ostomy Creation
Ostomy - Ileostomy or Colostomy, Stoma Complications
Not yet recruitingPhase 3
Evaluation of the Effect of Antibiotic Prophylaxis During Lumpectomy for Breast Cancer: Prospective Randomised Double-blind Noninferiority Study of Placebo vs Cefazolin
Breast Cancer, Breast Surgery
RecruitingPhase 3
Steroids for Facial Nerve Function Protection in Post-surgical Vestibular Schwannoma Patients
Vestibular Schwannoma, Facial Nerve Paralysis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Boris Jansen-Winkeln, PD Dr. contact
Ines Gockel, Prof. Dr. contact
Boris Jansen-Winkeln, PD Dr. principal investigator
University of Leipzig
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Surgical Site Infection and Anastomotic Leak, run by University of Leipzig at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Boris Jansen-Winkeln, PD Dr. (+49-314-97 ext. 17200, boris.jansen-winkeln@medizin.uni-leipzig.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgical Site Infections (time frame: 30 days (exact 30 days after the Operation date)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03759886, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2020.