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Efficacy and Safety of CLIFE1 Gel in Benign Anorectal Surgery

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ClinicalTrials.gov Identifier: NCT02961855
Recruitment Status : Completed
First Posted : November 11, 2016
Last Update Posted : November 15, 2016
Sponsor:
Information provided by (Responsible Party):
María José Linares Gil, Hospital de Viladecans

September 27, 2016
November 11, 2016
November 15, 2016
January 2011
January 2013   (Final data collection date for primary outcome measure)
mean level of pain, as assessed by visual analog scale (VAS) [ Time Frame: 3 days post-surgery ]
Same as current
Complete list of historical versions of study NCT02961855 on ClinicalTrials.gov Archive Site
  • 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
  • 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 treament (6 levels)
  • demographic and clinical characteristics [ Time Frame: baseline ]
    sex
  • demographic and clinical characteristics [ Time Frame: baseline ]
    age
  • safety evaluation as assessed by recording fo adverse events [ Time Frame: 6 days post-surgery ]
    recording of adverse events
Not Provided
Not Provided
 
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.

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

Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Fissure;Anal
  • Fistula;Rectal
  • Hemorrhoids
  • 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
  • Drug: local anesthesics, CLIFE2
    local anesthesics, CLIFE2 topical gel containing lidocaine local anesthesics
    Other Names:
    • lidocaine
    • CLEFE2 topical gel
  • 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
    Intervention: Drug: anesthesics plus antiinflammatory, CLIFE1
  • 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
    Intervention: Drug: local anesthesics, CLIFE2
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
120
Same as current
December 2013
January 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT02961855
CLIFE-01FV
Yes
Not Provided
Plan to Share IPD: No
María José Linares Gil, Hospital de Viladecans
Hospital de Viladecans
Not Provided
Not Provided
Hospital de Viladecans
November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP