Efficacy and Safety of CLIFE1 Gel in Benign Anorectal Surgery

Hospital de Viladecans120 enrolled

Overview

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.

120 patients were randomly assigned to two groups (60 in each group). The study was conducted in two parallel groups, with 1:1 randomization stratified by type of surgery and centre. Treatment with CLIFE 1 and CLIFE 2 was applied from day 1 to day 6 post-surgery

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

120

Conditions

Fissure;Anal Fistula;Rectal Hemorrhoids

Interventions

anesthesics plus antiinflammatory, CLIFE1DRUG

anesthesics plus antiinflammatory, CLIFE1 topical gel containing lidocaine plus diclofenac anesthesics plus antiinflammatory

local anesthesics, CLIFE2DRUG

local anesthesics, CLIFE2 topical gel containing lidocaine local anesthesics

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

mean level of pain, as assessed by visual analog scale (VAS)

Time frame: 3 days post-surgery

Secondary Outcomes

Mean level of pain (VAS) at day 3 post-surgery

Time frame: 6 days post-surgery

Level of pain (VAS), assessed by Andersen scale

Time frame: 6 days post-surgery

Pain relief

Question about pain relief in comparison with the last application (scores from 0 to 4).

Time frame: 6 days post-surgery

analgesics use

Time frame: 6 days post-surgery

patient satisfaction

Satisfaction questionnaire about the efficacy of treatment (6 levels)

Time frame: 6 days post-surgery

demographic and clinical characteristics-1

sex

Time frame: baseline

demographic and clinical characteristics-2

age

Time frame: baseline

safety evaluation as assessed by recording fo adverse events

recording of adverse events

Time frame: 6 days post-surgery

Data from ClinicalTrials.gov

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