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Effectiveness of Metronidazole in Pain Control Posthemorrhoidectomy

Information source: Instituto Mexicano del Seguro Social
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hemorrhoids

Intervention: Metronidazole (Drug); Placebo (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Instituto Mexicano del Seguro Social

Official(s) and/or principal investigator(s):
Clotilde Fuentes-Orozco, PhD, Principal Investigator, Affiliation: Instituto Mexicano del Seguro Social

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

Clinical Details

Official title: Effectiveness of Metronidazole Versus Homologated Placebo in Pain Control Posthemorrhoidectomy

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Pain evolution, hours and days after surgery

Secondary outcome:

Interleukin

Analgesics

Surgery complications

Return to normal activities

Satisfaction

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

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Hemorrhoidal disease grade III and IV

- Informed consent

Exclusion Criteria:

- Pregnancy

- Lactation

- Other anorectal disease

- Previous anorectal

- hypersensibility to metronidazole

Locations and Contacts

Western Medical Center, Mexican Institute of Social Security, Guadalajara, Jalisco 44340, Mexico
Additional Information

Starting date: July 2013
Last updated: December 26, 2014

Page last updated: August 23, 2015

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