Clinical trial · Interventional
Trial of Antibiotic Prophylaxis in Elective Laparoscopic Colorectal Surgery: Oral and Systemic Versus Systemic Antibiotics
Randomized Controlled Trial of Antibiotic Prophylaxis in Elective Laparoscopic Colorectal Surgery: Oral and Systemic Versus Systemic Antibiotics
NCT00508690CI-TRIAL-00008048completedPhase 3ClinicalTrials.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)
The purpose of this study is to determine optimal prophylactic antibiotics administration method in elective laparoscopic colorectal 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 |
|---|---|---|---|
| Colorectal Neoplasms | Colorectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cefmetazole | Drug | — | UNRESOLVED |
| kanamycin/metronidazole | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- IV
- description
- Intravenous dose of 1g cefmetazole just before surgery and additional doses every 3hs during surgery
- interventionNames
- Drug: cefmetazole
- type
- ACTIVE_COMPARATOR
- label
- Oral/IV
- description
- 2 doses of oral kanamycin(1g)/ metronidazole(750mg) administration on the day before surgery with intravenous dose of 1g cefmetazole just before surgery and additional doses every 3hs during surgery
- interventionNames
- Drug: kanamycin/metronidazole
Primary outcomes (1)
- measure
- Incidence and classification of surgical site infection (SSI)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: * Colorectal tumor(cancer, adenoma and suspected cases) with planned elective laparoscopic colorectal resection Exclusion Criteria: * ECOG Performance Status \>=2 * Age\<20 * Any organ dysfunction * Ileus * Preoperative infectious disease * Antibiotic administration before surgery * Steroid administration before surgery * Neo-adjuvant radiation and/or chemo therapy * Severe diabetes mellitus * Pregnancy/lactational woman * Severe allergy
References
Publications (0)
Data not yet available
No reference posted for this study.