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Efficacy and Safety of CLIFE1 Gel in Benign Anorectal Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02961855
Recruitment Status : Completed
First Posted : November 11, 2016
Last Update Posted : November 15, 2016
Information provided by (Responsible Party):
María José Linares Gil, Hospital de Viladecans

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Fissure;Anal Fistula;Rectal Hemorrhoids Drug: anesthesics plus antiinflammatory, CLIFE1 Drug: local anesthesics, CLIFE2 Phase 4

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Double-blinded Multicenter Randomized Clinical Trial to Evaluate the Efficacy and Safety of CLIFE1 and CLIFE2 Gels in Benign Anorectal Surgery
Study Start Date : January 2011
Actual Primary Completion Date : January 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. mean level of pain, as assessed by visual analog scale (VAS) [ Time Frame: 3 days post-surgery ]

Secondary Outcome Measures :
  1. Mean level of pain (VAS) at day 3 post-surgery [ Time Frame: 6 days post-surgery ]
  2. Level of pain (VAS), assessed by Andersen scale [ Time Frame: 6 days post-surgery ]
  3. Pain relief [ Time Frame: 6 days post-surgery ]
    Question about pain relief in comparison with the last application (scores from 0 to 4).

  4. analgesics use [ Time Frame: 6 days post-surgery ]
  5. patient satisfaction [ Time Frame: 6 days post-surgery ]
    Satisfaction questionnaire about the efficacy of treatment (6 levels)

  6. demographic and clinical characteristics-1 [ Time Frame: baseline ]

  7. demographic and clinical characteristics-2 [ Time Frame: baseline ]

  8. safety evaluation as assessed by recording fo adverse events [ Time Frame: 6 days post-surgery ]
    recording of adverse events

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Responsible Party: María José Linares Gil, Doctor, Hospital de Viladecans Identifier: NCT02961855    
Other Study ID Numbers: CLIFE-01FV
First Posted: November 11, 2016    Key Record Dates
Last Update Posted: November 15, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Rectal Fistula
Pathological Conditions, Anatomical
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Vascular Diseases
Cardiovascular Diseases
Intestinal Fistula
Digestive System Fistula
Anti-Inflammatory Agents
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Antirheumatic Agents