NCT02961855

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Hospital de Viladecans · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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

Conditions

• Fissure;Anal
• Fistula;Rectal
• Hemorrhoids

Interventions

Type	Name	Description
DRUG	anesthesics plus antiinflammatory, CLIFE1	anesthesics plus antiinflammatory, CLIFE1 topical gel containing lidocaine plus diclofenac anesthesics plus antiinflammatory
DRUG	local anesthesics, CLIFE2	local anesthesics, CLIFE2 topical gel containing lidocaine local anesthesics

Timeline

• Start date: 2011-01-01
• Primary completion: 2013-01-01
• Completion: 2013-12-01
• First posted: 2016-11-11
• Last updated: 2016-11-15