Hemorrhoids Clinical Trial
Official title:
Double-blinded Multicenter Randomized Clinical Trial to Evaluate the Efficacy and Safety of CLIFE1 and CLIFE2 Gels in Benign Anorectal Surgery
Double-blinded multicenter randomized clinical trial to evaluate the efficacy and safety of CLIFE2 (lidocaine, referred as treatment A) respect CLIFE1 (lidocaine plus diclofenac, referred as treatment B) in benign anorectal surgery.
Status | Completed |
Enrollment | 120 |
Est. completion date | December 2013 |
Est. primary completion date | January 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Patients undergoing benign anorectal surgery (out or inpatients), with the following diagnoses: anal fissure, fistula, hemorrhoids - Use of subarachnoid anesthesia with lidocaine Exclusion Criteria: - Allergy or Hypersensitivity to lidocaine or other local anesthesics. - Patients not accepting subarachnoid anesthesia - Patients with general anesthesia - Hypersensitivity or contraindication to acetylsalicylic acid. - History of gastrointestinal hemorrhage or perforation due to nonsteroidal anti-inflammatory drugs (NSAIDs) use - Active or relapsing peptic ulcer/gastrointestinal hemorrhage - Serious heart failure. - Active Crohn disease - Active ulcerative colitis - Moderate or sever renal failure - Severe liver disfunction - Coagulation disorders requiring treatment with anticoagulant drugs - Proctitis (due to autoimmune disease, foreign substances, sucally transmitted diseases - Treatment with: Beta blockers, calcium channel blockers (verapamil and diltiazem), anti-arrhythmics (digoxin, amiodarone), ivabradine, lithium, steroids - Pregnancy |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Hospital de Viladecans |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | mean level of pain, as assessed by visual analog scale (VAS) | 3 days post-surgery | No | |
Secondary | Mean level of pain (VAS) at day 3 post-surgery | 6 days post-surgery | No | |
Secondary | Level of pain (VAS), assessed by Andersen scale | 6 days post-surgery | No | |
Secondary | Pain relief | Question about pain relief in comparison with the last application (scores from 0 to 4). | 6 days post-surgery | No |
Secondary | analgesics use | 6 days post-surgery | No | |
Secondary | patient satisfaction | Satisfaction questionnaire about the efficacy of treatment (6 levels) | 6 days post-surgery | No |
Secondary | demographic and clinical characteristics-1 | sex | baseline | No |
Secondary | demographic and clinical characteristics-2 | age | baseline | No |
Secondary | safety evaluation as assessed by recording fo adverse events | recording of adverse events | 6 days post-surgery | Yes |
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