Orally Administered Trimethoprim-Sulfamethoxazole and Metronidazole as Prophylaxis of Infection Following Elective Colorectal Surgery
Information source: Halmstad County Hospital
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Colorectal Surgery
Intervention: trimethoprim-sulfamethoxazole + metronidazole (Drug); cefuroxime and metronidazole (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Halmstad County Hospital Official(s) and/or principal investigator(s):
Claes Hjalmarsson, MD,PhD, Principal Investigator, Affiliation: Department of Surgery and Onkology, Community Hospital in Halmstad, 301 85 Halmstad, Sweden
Overall contact:
Claes Hjalmarsson, MD,PhD, Phone: 0046-35-131000, Email: claes.hjalmarsson@lthalland.se
Summary
The current standard Swedish infection prophylaxis in colorectal surgery is intravenously
administered cefuroxime and metronidazole. this combination is well studied. The
disadvantages of the regimen is "collateral damage" resulting from treatment with a
cephalosporine and that the combination also serves as the first line of treatment for
abdominal surgical infections.
Serval Swedish surgical departments have for some years used a combination of orally
administered trimethoprim-sulfamethoxazole and metronidazole.
The combination is economical and believed to be effective but hitherto the outcome have not
been properly researched.
The aim of this study is to compare the efficacy of these two regimens in the prevention of
infection after elective colorectal surgery.
Clinical Details
Official title: A Prospective, Randomized, Blind, Multicenter Trial Comparing Orally Administered Trimethoprim-Sulfamethoxazole With Intravenously Administered Cefuroxime and Metronidazole as Prophylaxis of Infection Following Elective Colorectal Surgery.
Study design: Prevention, Randomized, Double Blind (Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study
Primary outcome: Cutaneous-,subcutaneous and intraabdominal infectionsOther postoperative infections (such as pneumonia) Septicaemia
Secondary outcome: Non infectious wound complicationsComplications to the anastomosis Adverse reaction of given drug
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Age >= 18 years
- Planned clean/clean-contaminated colorectal resection will be performed
- Understand spoken and written swedish language
Exclusion Criteria:
- Hypersensibility to the test or control drug
- Severe liver failure
- blood dyscrasia
- ileus or gastric retention
- current visceral perforation
- current treatment with antibiotics
- current treatment with steroids
- cytotoxic or radiation therapy within 4 weeks of the planned operation
- active IBD (inflammatory bowel disease)
- incapability to swallow tablets
- other study interfering with this study
- current pregnancy
- bad regulated diabetes
- current enterocutaneous or colocutaneous fistula
Locations and Contacts
Claes Hjalmarsson, MD,PhD, Phone: 0046-35-131000, Email: claes.hjalmarsson@lthalland.se
Department of Surgery, University Hospital UMAS, Malmö 205 02, Sweden; Recruiting
Hassan Zaigham, MD, Phone: 0046-40-331000, Email: hassan.zaigham@skane.se
Ingrid Palmquist, RN, Phone: 0046-40-331000, Email: ingrid.palmquist@skane.se
Department of Surgery and oncology, Community Hospital in Halmstad, Halmstad 301 85, Sweden; Recruiting
Claes Hjalmarsson, MD,PhD, Phone: 0046-35-131000, Email: claes.hjalmarsson@lthalland.se
Jonas Karlberg, MD, Phone: 0046-35-131000, Email: jonas.karlberg@lthalland.se
Pelle Törnquist, MD, Sub-Investigator
Department of Surgery, University hospital Sahlgrenska/Östra, Gothenburg 416 85, Sweden; Recruiting
Winfried Sieler, MD, Phone: 0046-31-3434000, Email: winfrie.sieler@vgregion.se
Department of surgery, Community Hospital i Karlskrona, Karlskrona 371 85, Sweden; Recruiting
Mattias Söderholm, MD, Phone: 0046-455-731000, Email: mattias.soderholm@ltblekinge.se
Department of surgery, Skövde 541 85, Sweden; Recruiting
Björn Frisk, MD, Phone: 0046-500-431000, Email: bjorn.frisk@vgregion.se
Marina Modin, RN, Phone: 0046-500-431000, Email: marina.modin@vgregion.se
Additional Information
Starting date: September 2007
Last updated: May 19, 2008
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