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Efficacy and Safety of CLIFE1 Gel in Benign Anorectal Surgery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
María José Linares Gil, Hospital de Viladecans
ClinicalTrials.gov Identifier:
NCT02961855
First received: September 27, 2016
Last updated: November 14, 2016
Last verified: November 2016
  Purpose
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 Intervention Phase
Fissure;Anal Fistula;Rectal Hemorrhoids Drug: anesthesics plus antiinflammatory, CLIFE1 Drug: local anesthesics, CLIFE2 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (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

Resource links provided by NLM:


Further study details as provided by María José Linares Gil, Hospital de Viladecans:

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

Secondary Outcome Measures:
  • 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 [ Time Frame: 6 days post-surgery ]
    Question about pain relief in comparison with the last application (scores from 0 to 4).

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

  • demographic and clinical characteristics-1 [ Time Frame: baseline ]
    sex

  • demographic and clinical characteristics-2 [ Time Frame: baseline ]
    age

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


Enrollment: 120
Study Start Date: January 2011
Study Completion Date: December 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

  Eligibility

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

Responsible Party: María José Linares Gil, Doctor, Hospital de Viladecans
ClinicalTrials.gov Identifier: NCT02961855     History of Changes
Other Study ID Numbers: CLIFE-01FV
Study First Received: September 27, 2016
Last Updated: November 14, 2016
Individual Participant Data  
Plan to Share IPD: No

Additional relevant MeSH terms:
Fistula
Hemorrhoids
Fissure in Ano
Rectal Fistula
Pathological Conditions, Anatomical
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Vascular Diseases
Cardiovascular Diseases
Anus Diseases
Intestinal Fistula
Digestive System Fistula
Lidocaine
Diclofenac
Anti-Inflammatory Agents
Anesthetics, Local
Anesthetics
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

ClinicalTrials.gov processed this record on June 26, 2017