Back to results

Efficacy and Safety of CLIFE1 Gel in Benign Anorectal Surgery

Primary Purpose

Fissure;Anal, Fistula;Rectal, Hemorrhoids

Status

Completed

Phase

Phase 4

Locations

Study Type

Interventional

Intervention

anesthesics plus antiinflammatory, CLIFE1

local anesthesics, CLIFE2

About this trial

This is an interventional treatment trial for Fissure;Anal

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Clife1 gel (lidocaine plus diclofenac)

Clife2 gel (lidocaine)

Arm 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

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

Outcomes

Primary Outcome Measures

mean level of pain, as assessed by visual analog scale (VAS)

Secondary Outcome Measures

Mean level of pain (VAS) at day 3 post-surgery

Level of pain (VAS), assessed by Andersen scale

Pain relief

Question about pain relief in comparison with the last application (scores from 0 to 4).

analgesics use

patient satisfaction

Satisfaction questionnaire about the efficacy of treatment (6 levels)

demographic and clinical characteristics-1

sex

demographic and clinical characteristics-2

age

safety evaluation as assessed by recording fo adverse events

recording of adverse events

Full Information

NCT ID

NCT02961855

First Posted

September 27, 2016

Last Updated

November 14, 2016

Sponsor

Hospital de Viladecans

1. Study Identification

Unique Protocol Identification Number

NCT02961855

Brief Title

Efficacy and Safety of CLIFE1 Gel in Benign Anorectal Surgery

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2016

Overall Recruitment Status

Completed

Study Start Date

January 2011 (undefined)

Primary Completion Date

January 2013 (Actual)

Study Completion Date

December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Hospital de Viladecans

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Fissure;Anal, Fistula;Rectal, Hemorrhoids

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

120 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Clife1 gel (lidocaine plus diclofenac)

Arm Type

Experimental

Arm Description

Arm Title

Clife2 gel (lidocaine)

Arm Type

Active Comparator

Arm 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

Intervention Type

Drug

Intervention Name(s)

anesthesics plus antiinflammatory, CLIFE1

Other Intervention Name(s)

lidocaine plus diclofenac, CLIFE1 topical gel

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

local anesthesics, CLIFE2

Other Intervention Name(s)

lidocaine, CLEFE2 topical gel

Intervention Description

local anesthesics, CLIFE2 topical gel containing lidocaine local anesthesics

Primary Outcome Measure Information:

Title

mean level of pain, as assessed by visual analog scale (VAS)

Time Frame

3 days post-surgery

Secondary Outcome Measure Information:

Title

Mean level of pain (VAS) at day 3 post-surgery

Time Frame

6 days post-surgery

Title

Level of pain (VAS), assessed by Andersen scale

Time Frame

6 days post-surgery

Title

Pain relief

Description

Question about pain relief in comparison with the last application (scores from 0 to 4).

Time Frame

6 days post-surgery

Title

analgesics use

Time Frame

6 days post-surgery

Title

patient satisfaction

Description

Satisfaction questionnaire about the efficacy of treatment (6 levels)

Time Frame

6 days post-surgery

Title

demographic and clinical characteristics-1

Description

sex

Time Frame

baseline

Title

demographic and clinical characteristics-2

Description

age

Time Frame

baseline

Title

safety evaluation as assessed by recording fo adverse events

Description

recording of adverse events

Time Frame

6 days post-surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Efficacy and Safety of CLIFE1 Gel in Benign Anorectal Surgery

We'll reach out to this number within 24 hrs