Clinical trial · Interventional
Antibiotic Prophylaxis in Rectal Cancer Surgery: Oral With Intravenous Versus Intravenous Antibiotics.
Randomized Controlled Trial of Antibiotic Prophylaxis in Rectal Cancer Surgery: Oral With Intravenous Versus Intravenous Antibiotics.
NCT03436719CI-TRIAL-00037423unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a randomized, controlled, parallel study to determine the efficiency of oral antibiotics in reduction of surgical site infection (SSI) in rectal cancer surgery.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Intravenous antibiotic | Drug | — | UNRESOLVED |
| Mechanical Bowel Preparation | Drug | — | UNRESOLVED |
| Oral antibiotic | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Oral with Intravenous
- description
- Oral metronidazole and erythromycine administration on the day before surgery with intravenous cefoperazone before surgery (30-90 min) and additional doses every third hour during surgery
- interventionNames
- Drug: Oral antibiotic
- Drug: Intravenous antibiotic
- Drug: Mechanical Bowel Preparation
- type
- ACTIVE_COMPARATOR
- label
- Intravenous
- description
- Intravenous dose cefoperazone before surgery (30-90 min) and additional doses every third hour during surgery
- interventionNames
- Drug: Intravenous antibiotic
- Drug: Mechanical Bowel Preparation
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Have a planned of resection of rectum * Have signed approved informed consent form for the study. Exclusion Criteria: * Significant simultaneous surgical procedure (e.g., liver resection of metastasis) * Bacterial infection at the time of surgery or antimicrobial therapy up to 4 weeks before surgery * Preoperative severe impairment in renal function (creatinine clearance (MDRD) \< 30 ml/min) * Allergy on the study drugs .
References
Publications (0)
Data not yet available
No reference posted for this study.