Efficacy and Safety of CLIFE1 Gel in Benign Anorectal Surgery

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.

Study Overview

• Status: Completed
• Conditions: Hemorrhoids; Fistula;Rectal; Fissure;Anal
• Intervention / Treatment: Drug: anesthesics plus antiinflammatory, CLIFE1; Drug: local anesthesics, CLIFE2

Detailed Description

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
• Enrollment (Actual): 120
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Clife1 gel (lidocaine plus diclofenac); Clife1 gel (lidocaine plus diclofenac) Topical gel containing lidocaine (2%) plus diclofenac (0.5%) (15 g in total) Application of the gel bid from first day post-surgery to day 3 and once daily from day 4 to day 6	Drug: anesthesics plus antiinflammatory, CLIFE1; anesthesics plus antiinflammatory, CLIFE1 topical gel containing lidocaine plus diclofenac anesthesics plus antiinflammatory; Other Names: lidocaine plus diclofenac; CLIFE1 topical gel
ACTIVE_COMPARATOR: Clife2 gel (lidocaine); Clife2 gel (lidocaine) Topical gel containing lidocaine (2%) (15 g in total) Application of the gel bid from first day post-surgery to day 3 and once daily from day 4 to day 6	Drug: local anesthesics, CLIFE2; local anesthesics, CLIFE2 topical gel containing lidocaine local anesthesics; Other Names: lidocaine; CLEFE2 topical gel

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
mean level of pain, as assessed by visual analog scale (VAS)	3 days post-surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean level of pain (VAS) at day 3 post-surgery		6 days post-surgery
Level of pain (VAS), assessed by Andersen scale		6 days post-surgery
Pain relief	Question about pain relief in comparison with the last application (scores from 0 to 4).	6 days post-surgery
analgesics use		6 days post-surgery
patient satisfaction	Satisfaction questionnaire about the efficacy of treatment (6 levels)	6 days post-surgery
demographic and clinical characteristics-1	sex	baseline
demographic and clinical characteristics-2	age	baseline
safety evaluation as assessed by recording fo adverse events	recording of adverse events	6 days post-surgery

Collaborators and Investigators

• Sponsor: Hospital de Viladecans

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (ACTUAL): January 1, 2013
• Study Completion (ACTUAL): December 1, 2013

Study Registration Dates

• First Submitted: September 27, 2016
• First Submitted That Met QC Criteria: November 8, 2016
• First Posted (ESTIMATE): November 11, 2016

Study Record Updates

• Last Update Posted (ESTIMATE): November 15, 2016
• Last Update Submitted That Met QC Criteria: November 14, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Cardiovascular Diseases; Vascular Diseases; Gastrointestinal Diseases; Intestinal Diseases; Pathological Conditions, Anatomical; Rectal Diseases; Intestinal Fistula; Digestive System Fistula; Fistula; Rectal Fistula; Hemorrhoids; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anesthetics; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Antirheumatic Agents; Cyclooxygenase Inhibitors; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine; Anti-Inflammatory Agents; Diclofenac
• Other Study ID Numbers: CLIFE-01FV

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO