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Efficacy and Safety of CLIFE1 Gel in Benign Anorectal Surgery

NCT ID: NCT02961855

Last Updated: 2016-11-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2013-12-31

Brief Summary

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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

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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

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Fissure;Anal Fistula;Rectal Hemorrhoids

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Clife1 gel (lidocaine plus diclofenac)

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

Group Type EXPERIMENTAL

anesthesics plus antiinflammatory, CLIFE1

Intervention Type DRUG

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

Clife2 gel (lidocaine)

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

Group Type ACTIVE_COMPARATOR

local anesthesics, CLIFE2

Intervention Type DRUG

local anesthesics, CLIFE2 topical gel containing lidocaine local anesthesics

Interventions

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anesthesics plus antiinflammatory, CLIFE1

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

Intervention Type DRUG

local anesthesics, CLIFE2

local anesthesics, CLIFE2 topical gel containing lidocaine local anesthesics

Intervention Type DRUG

Other Intervention Names

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lidocaine plus diclofenac CLIFE1 topical gel lidocaine CLEFE2 topical gel

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital de Viladecans

OTHER

Sponsor Role lead

Responsible Party

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María José Linares Gil

Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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CLIFE-01FV

Identifier Type: -

Identifier Source: org_study_id