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Completed

NCT Number: NCT02961855

Efficacy and Safety of CLIFE1 Gel 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.

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Key information

Conditions

Fissure;Anal Anus Diseases Cardiovascular Diseases Digestive System Diseases Digestive System Fistula Fissure in Ano Fistula Fistula;Rectal Gastrointestinal Diseases Hemorrhoids Intestinal Diseases Intestinal Fistula Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Rectal Diseases Rectal Fistula Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

anesthesics plus antiinflammatory, CLIFE1

Drug

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

Other names: lidocaine plus diclofenac, CLIFE1 topical gel

local anesthesics, CLIFE2

Drug

local anesthesics, CLIFE2 topical gel containing lidocaine local anesthesics

Other names: lidocaine, CLEFE2 topical gel

Primary outcomes

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

    Time frame: 3 days post-surgery

Secondary outcomes

  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

    sex

  7. demographic and clinical characteristics-2

    Time frame: baseline

    age

  8. safety evaluation as assessed by recording fo adverse events

    Time frame: 6 days post-surgery

    recording of adverse events

Sponsors and collaborators

Lead sponsor

Hospital de Viladecans

Other

Registry information

Official study title

Double-blinded Multicenter Randomized Clinical Trial to Evaluate the Efficacy and Safety of CLIFE1 and CLIFE2 Gels in Benign Anorectal Surgery

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Nov 11, 2016
Registry last updated
Nov 15, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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