Clinical trial NCT01961739: Topical 2% Lidocaine for the Treatment of Symptomatic Hemorrhoids
Official title: Double Blinded Randomized Clinical Trial of the Efficacy of Topical 2% Lidocaine for the Treatment of Symptomatic Hemorrhoids
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Hemorrhoids
Keywords: Hemorrhoids
Lidocaine
Lead sponsor: University Hospital Dubrava
Sponsor class: OTHER
Collaborators: name: Clinical Hospital Centre Zagreb
First posted: 2013-10-11
Enrollment: 138
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to evaluate the efficacy of topical 2% lidocaine in the therapy of symptomatic hemorrhoids. Efficacy will be determined by:

1. the change from baseline in pain, itching, bleeding, swelling, discomfort, general well-being and improvement since the beginning of treatment as separate components of CORRECTS scale
2. the change in overall CORRECTS values from baseline
3. the change in degree of hemorrhoids from baseline

Detailed description: This is a double blinded randomized clinical study into the effect of topical 2% lidocaine in patients with symptomatic hemorrhoids.

Calculated sample size is 69 patients per arm, based on expected improvement of pain and healing by 30% at p\<0.05 and power goal of 95%. Taking into account a drop-out rate of 50%, total number of 69 patients in each arm is estimated as sufficient to close the study.

Patients will be randomly assigned into 2 arms, arm 1 (treatment): topical 2% lidocaine and arm 2 (control): vaseline base. Each arm will consist of 69 patients. Patients will be assigned to either treatment or control arm according to the randomization table.

* Treatment arm - topical 2% lidocaine. Topical application of 2% lidocaine in vaseline base repeated two times per day,
* Control arm - vaseline base. Topical application of pure vaseline base twice per day.

In addition to the aforementioned topical treatments, all patients will be given written instructions to perform dietary modifications and anal hygiene. All patients with bleeding hemorrhoids will be given Detralex 2 tablets twice per day.

Those patients in whom a technically successful procedure has been completed will be considered as valuable for the efficacy evaluation. A technically successful procedure is defined as the completion of treatment procedures stipulated in this protocol and consists of correct drug dose and frequency of application, adherence to written instructions for dietary modification and anal hygiene and presence at follow-up visits.

Eligibility criteria: Inclusion Criteria:

* clinically present enlarged hemorrhoids, grade 1-4 (for definition see Appendix 1)
* symptoms of pain or itching
* age 18 years or more
* willing and able to comply with the study
* geographically suitable, meaning with reliable transportation for outpatients to the testing site

Exclusion Criteria:

* actual pregnancy
* inability to provide informed consent
* any anal topical medication applied in the last 7 days
* any anal surgery (including surgical or instrumental procedures defined in the section 4.3) in the last 60 days
* known allergy to vaseline, lidocaine or Dulcolax
* other anal disorders and diseases including Crohns disease, ulcerative colitis, undefined inflammatory bowel disease, anal fissures, perianal fistulas, perianal rash or eczema, rectal prolapse, rectocele, benign or malignant anal and rectal tumor and perianal infections
* contraindication for topical anal application of vaseline or lidocaine

Primary outcomes:
measure: Change in CORRECTS scale
timeFrame: 15 days after treatment initiantion
Secondary outcomes:
measure: Percentage of adverse events
timeFrame: within 15 days after treatment initiation
Other outcomes:
Locations:
city: Zagreb
country: Croatia
facility: Clinical Hospital Centre Zagreb
city: Zagreb
country: Croatia
facility: Clinical Hospital Dubrava
Study officials:
affiliation: University Hospital Dubrava
name: Mario Kopljar, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinical Hospital Centre Zagreb
name: Tihomir Kekez
role: PRINCIPAL_INVESTIGATOR
References: