Effectiveness of Metronidazole in Pain Control Posthemorrhoidectomy
Primary Purpose
Hemorrhoids
Status
Completed
Phase
Phase 3
Locations
Mexico
Study Type
Interventional
Intervention
Metronidazole
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Hemorrhoids focused on measuring Hemorrhoidectomy, Postoperative pain, Metronidazole
Eligibility Criteria
Inclusion Criteria:
- Hemorrhoidal disease grade III and IV
- Informed consent
Exclusion Criteria:
- Pregnancy
- Lactation
- Other anorectal disease
- Previous anorectal
- hypersensibility to metronidazole
Sites / Locations
- Western Medical Center, Mexican Institute of Social Security
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Metronidazole
Placebo
Arm Description
22 patients received oral metronidazole 500mg 3 times for day for 7 days
22 patients received oral placebo 500mg 3 times for day for 7 days
Outcomes
Primary Outcome Measures
Pain evolution, hours and days after surgery
Pain was assessed with the visual analogue scale questionnaire
Secondary Outcome Measures
Interleukin
In a blood sample, right after surgery and 12 hours later, interleukin 6 and 10 were measured by ELISA, observing if they presented alterations with the intervention, between 2 groups and between the hours the investigators took the blood sample
Analgesics
Using a questionnaire if they used analgesics, which one, dose of it and how many days
Surgery complications
Asking directly to participants if they presented bleeding, urinary retention or another complication. Investigators measured how many participants presented complications
Return to normal activities
Asking to participans when they return to normal activities (to walk normally, to cook, to bath, to wear, to work) How many days were needed to recover their normal activities
Satisfaction
Asking how they felt in last 14 days and what was their perception of the surgery
Full Information
NCT ID
NCT02328144
First Posted
December 22, 2014
Last Updated
December 26, 2014
Sponsor
Instituto Mexicano del Seguro Social
1. Study Identification
Unique Protocol Identification Number
NCT02328144
Brief Title
Effectiveness of Metronidazole in Pain Control Posthemorrhoidectomy
Official Title
Effectiveness of Metronidazole Versus Homologated Placebo in Pain Control Posthemorrhoidectomy
Study Type
Interventional
2. Study Status
Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
July 2013 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
October 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Instituto Mexicano del Seguro Social
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Hemorrhoidal disease occurs in 50% of people over 40 years old and is the most common cause of anorectal surgery. One of the complications of hemorrhoidectomy is pain, which is a difficult symptom to appreciate and assess, by its frequent and large variations in sensitivity in each patient. Many studies have been done to reduce patient postoperative pain, but there is no ideal method. The application of both oral and topical metronidazole has shown to decrease pain following hemorrhoidectomy, but its use is not standardized.
The investigators evaluated the effect of oral administration of metronidazole versus homologated placebo in pain control after hemorrhoidectomy
Detailed Description
Objective: Evaluate the effect of oral administration of metronidazole versus homologated placebo in pain control after hemorrhoidectomy.
Material and methods: Controlled clinical trial, composed of 44 patients in a randomized manner, realized at the Coloproctology, Western Medical Center, Mexican Institute of Social Security. Referred beneficiaries adults were included, of either sex, who merited elective hemorrhoidectomy for hemorrhoidal disease grades III-IV using Ferguson's technique. They were assigned to receive metronidazole (study group) or homologated (control group) and the randomization was conducted by sealed envelopes and subsequently. We collected demographic and clinical variables. Postoperative pain was assessed by visual analog scale at 6 and 12hrs, 1, 4, 7 and 14 days; additional analgesic use; complications; return to normal activity and patient satisfaction; also were measured, in a blood sample after surgery and 12 hrs later, interleukin 6 and 10.
The statistical analysis was performed according to the nature of variables, for continuous data using measures of central tendency and dispersion and for the qualitative data with frequencies and percentages
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemorrhoids
Keywords
Hemorrhoidectomy, Postoperative pain, Metronidazole
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
44 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Metronidazole
Arm Type
Active Comparator
Arm Description
22 patients received oral metronidazole 500mg 3 times for day for 7 days
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
22 patients received oral placebo 500mg 3 times for day for 7 days
Intervention Type
Drug
Intervention Name(s)
Metronidazole
Other Intervention Name(s)
Flagyl
Intervention Description
Patients were assigned to two groups, one of them received oral metronidazole (study group) and the other, homologated placebo (control group) after hemorrhoidectomy. Then, postoperative pain was assessed by visual analog scale at 6 and 12hrs, 1, 4, 7 and 14 days
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Homologated Placebo
Intervention Description
Patients were assigned to two groups, one of them received oral metronidazole (study group) and the other, homologated placebo (control group) after hemorrhoidectomy. Then, postoperative pain was assessed by visual analog scale at 6 and 12hrs, 1, 4, 7 and 14 days.
Primary Outcome Measure Information:
Title
Pain evolution, hours and days after surgery
Description
Pain was assessed with the visual analogue scale questionnaire
Time Frame
6 and 12 hours, 1, 4, 7 and 14 days
Secondary Outcome Measure Information:
Title
Interleukin
Description
In a blood sample, right after surgery and 12 hours later, interleukin 6 and 10 were measured by ELISA, observing if they presented alterations with the intervention, between 2 groups and between the hours the investigators took the blood sample
Time Frame
after surgery and 12 hours
Title
Analgesics
Description
Using a questionnaire if they used analgesics, which one, dose of it and how many days
Time Frame
6 and 12 hours, 1, 4, 7 and 14 days
Title
Surgery complications
Description
Asking directly to participants if they presented bleeding, urinary retention or another complication. Investigators measured how many participants presented complications
Time Frame
6 and 12 hours, 1, 4, 7 and 14 days
Title
Return to normal activities
Description
Asking to participans when they return to normal activities (to walk normally, to cook, to bath, to wear, to work) How many days were needed to recover their normal activities
Time Frame
1, 4, 7 and 14 days
Title
Satisfaction
Description
Asking how they felt in last 14 days and what was their perception of the surgery
Time Frame
14 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Hemorrhoidal disease grade III and IV
Informed consent
Exclusion Criteria:
Pregnancy
Lactation
Other anorectal disease
Previous anorectal
hypersensibility to metronidazole
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clotilde Fuentes-Orozco, PhD
Organizational Affiliation
Instituto Mexicano del Seguro Social
Official's Role
Principal Investigator
Facility Information:
Facility Name
Western Medical Center, Mexican Institute of Social Security
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44340
Country
Mexico
12. IPD Sharing Statement
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Effectiveness of Metronidazole in Pain Control Posthemorrhoidectomy
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