Efficacy and Safety of CLIFE1 Gel in Benign Anorectal Surgery

Hemorrhoids Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02961855
• Other study ID #: CLIFE-01FV
• Status: Completed
• Phase: Phase 4
• First received: September 27, 2016
• Last updated: November 14, 2016
• Start date: January 2011
• Est. completion date: December 2013

Study information

• Verified date: November 2016
• Source: Hospital de Viladecans
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: December 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fissure in Ano
• Fissure;Anal
• Fistula
• Fistula;Rectal
• Hemorrhoids
• Rectal Fistula

Intervention

Drug:
• anesthesics plus antiinflammatory, CLIFE1
anesthesics plus antiinflammatory, CLIFE1 topical gel containing lidocaine plus diclofenac anesthesics plus antiinflammatory
• local anesthesics, CLIFE2
local anesthesics, CLIFE2 topical gel containing lidocaine local anesthesics

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hospital de Viladecans

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mean level of pain, as assessed by visual analog scale (VAS)		3 days post-surgery	No
Secondary	Mean level of pain (VAS) at day 3 post-surgery		6 days post-surgery	No
Secondary	Level of pain (VAS), assessed by Andersen scale		6 days post-surgery	No
Secondary	Pain relief	Question about pain relief in comparison with the last application (scores from 0 to 4).	6 days post-surgery	No
Secondary	analgesics use		6 days post-surgery	No
Secondary	patient satisfaction	Satisfaction questionnaire about the efficacy of treatment (6 levels)	6 days post-surgery	No
Secondary	demographic and clinical characteristics-1	sex	baseline	No
Secondary	demographic and clinical characteristics-2	age	baseline	No
Secondary	safety evaluation as assessed by recording fo adverse events	recording of adverse events	6 days post-surgery	Yes