Effectiveness of Metronidazole in Pain Control Posthemorrhoidectomy
1 other identifier
interventional
44
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Jul 2013
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2014
CompletedFirst Submitted
Initial submission to the registry
December 22, 2014
CompletedFirst Posted
Study publicly available on registry
December 31, 2014
CompletedDecember 31, 2014
December 1, 2014
1.1 years
December 22, 2014
December 26, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pain evolution, hours and days after surgery
Pain was assessed with the visual analogue scale questionnaire
6 and 12 hours, 1, 4, 7 and 14 days
Secondary Outcomes (5)
Interleukin
after surgery and 12 hours
Analgesics
6 and 12 hours, 1, 4, 7 and 14 days
Surgery complications
6 and 12 hours, 1, 4, 7 and 14 days
Return to normal activities
1, 4, 7 and 14 days
Satisfaction
14 day
Study Arms (2)
Metronidazole
ACTIVE COMPARATOR22 patients received oral metronidazole 500mg 3 times for day for 7 days
Placebo
PLACEBO COMPARATOR22 patients received oral placebo 500mg 3 times for day for 7 days
Interventions
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
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.
Eligibility Criteria
You may qualify if:
- Hemorrhoidal disease grade III and IV
- Informed consent
You may not qualify if:
- Pregnancy
- Lactation
- Other anorectal disease
- Previous anorectal
- hypersensibility to metronidazole
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Western Medical Center, Mexican Institute of Social Security
Guadalajara, Jalisco, 44340, Mexico
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Clotilde Fuentes-Orozco, PhD
Instituto Mexicano del Seguro Social
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD
Study Record Dates
First Submitted
December 22, 2014
First Posted
December 31, 2014
Study Start
July 1, 2013
Primary Completion
August 1, 2014
Study Completion
October 1, 2014
Last Updated
December 31, 2014
Record last verified: 2014-12