Comparison of two preoperative antibiotic profilaxis to prevent surgical complications, infections in colonic surgery

SOAP Antibiotic prophylaxis trial Systemic versus combined systemic and Oral Antibiotic Prophylaxis in elective colorectal surgery - SOAP trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-005614-30-HU

Enrollment

450

Registered

2016-05-12

Start date

2016-07-07

Completion date

Unknown

Last updated

2019-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

In colorectal surgery wildely used bowel prep and systemic antibiotic prophylaxis. New data suggest that infective complications can be lowered if beside this regimen oral antibiotic profilaxis is applied.

Interventions

Trade Name: Nivemycin Product Name: Nivemycin Pharmaceutical Form: Tablet Trade Name: Klion Product Name: Klion Pharmac

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Voluntary participation agreement to the trial. 2. Indication for colorectal resection (benign/malignant disease, diverticulosis, colitis, IBD) 3. No contraindication for colorectal resection, and the survival expectation is more than 30 days 4. Age over 18 5. Preserved consciousness Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 200 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 250

Exclusion criteria

Exclusion criteria: 1. Refusing the participation in the trial 2. Previous intrabdominal sepsis/abscess 6 month before surgery 3. Urgent surgery 4. No resection and anastomosis at the procedure 5. Antibiotic treatment 14 days prior to surgery 6. Chronic steroid medication or immun compromised state 7. Allergy on any medicines of the trial 8. Gravidity, lactation 9. Protocol violence 10. Bowel preparation was unsuccesfull

Design outcomes

Primary

Measure	Time frame
Main Objective: This trial is designed to assess the benefit of oraly administred antibiotic prophylaxis beside bowelprep and venous antibiotic prophylaxis versus bowelprep and systemic antibiotic prophylaxis alone. The scope are postoperative and infective complications. ;Secondary Objective: Secondary objectives are anastomotic insufficiency, 30 day rehospitalization, 30 dax mortality and the relaitionship between CRP (C-reactive protein) and the infective complications. ;Primary end point(s): The primary end point of the trial are wound infections and postoperativ ileus. ;Timepoint(s) of evaluation of this end point: 30 days	—

Measure

Time frame

Main Objective: This trial is designed to assess the benefit of oraly administred antibiotic prophylaxis beside bowelprep and venous antibiotic prophylaxis versus bowelprep and systemic antibiotic prophylaxis alone. The scope are postoperative and infective complications. ;Secondary Objective: Secondary objectives are anastomotic insufficiency, 30 day rehospitalization, 30 dax mortality and the relaitionship between CRP (C-reactive protein) and the infective complications. ;Primary end point(s): The primary end point of the trial are wound infections and postoperativ ileus. ;Timepoint(s) of evaluation of this end point: 30 days

—

Secondary

Measure	Time frame
Secondary end point(s): Secondary endpoints are anastomotic insifficiency, 30 day rehospitalization, 30 day mortality and the relationship between CRP and infective complications.;Timepoint(s) of evaluation of this end point: 30 days	—

Countries

Hungary

Contacts

Public ContactSurgical and Oncosurgical Ward

Uzsoki Utcai Kórház

papgez@gmail.com36146737003794

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026