A Phase 4 interventional study of anesthesics plus antiinflammatory, CLIFE1 and local anesthesics, CLIFE2 in Fissure;Anal, Fistula;Rectal and Hemorrhoids, sponsored by Hospital de Viladecans. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-11-15.
Sponsored by Hospital de Viladecans · Phase 4, Interventional, and Treatment
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
221 studies on the registry are indexed under Hemorrhoids; 64 are open to participants now.
This study's enrollment of 120 is above the median of 97 across 169 interventional studies indexed under Hemorrhoids.
Browse Hemorrhoids studies →Hospital de Viladecans is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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
anesthesics plus antiinflammatory, CLIFE1 topical gel containing lidocaine plus diclofenac anesthesics plus antiinflammatory
Also known as: lidocaine plus diclofenac, CLIFE1 topical gel
local anesthesics, CLIFE2 topical gel containing lidocaine local anesthesics
Also known as: lidocaine, CLEFE2 topical gel
mean level of pain, as assessed by visual analog scale (VAS)
Time frame: 3 days post-surgery
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
Question about pain relief in comparison with the last application (scores from 0 to 4).
Time frame: 6 days post-surgery
analgesics use
Time frame: 6 days post-surgery
patient satisfaction
Satisfaction questionnaire about the efficacy of treatment (6 levels)
Time frame: 6 days post-surgery
demographic and clinical characteristics-1
sex
Time frame: baseline
demographic and clinical characteristics-2
age
Time frame: baseline
safety evaluation as assessed by recording fo adverse events
recording of adverse events
Time frame: 6 days post-surgery
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.
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Hospital de Viladecans