Efficacy and Safety of CLIFE1 Gel in Benign Anorectal Surgery

Hospital de Viladecans

Status and phase: Completed; Phase 4

Conditions: Fissure;Anal; Fistula;Rectal; Hemorrhoids

Treatments: Drug: anesthesics plus antiinflammatory, CLIFE1; Drug: local anesthesics, CLIFE2

Study type: Interventional

Funder types: Other

Identifiers

NCT02961855

CLIFE-01FV

Details and patient eligibility

About

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.

Full 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

Enrollment: 120 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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120 participants in 2 patient groups

Clife1 gel (lidocaine plus diclofenac)

Experimental group

Description:

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

Treatment:

Drug: anesthesics plus antiinflammatory, CLIFE1

Clife2 gel (lidocaine)

Active Comparator group

Description:

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

Treatment:

Drug: local anesthesics, CLIFE2