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Effectiveness of Metronidazole in Pain Control Posthemorrhoidectomy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
CLOTILDE FUENTES OROZCO, Instituto Mexicano del Seguro Social
ClinicalTrials.gov Identifier:
NCT02328144
First received: December 22, 2014
Last updated: December 26, 2014
Last verified: December 2014
  Purpose

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


Condition Intervention Phase
Hemorrhoids Drug: Metronidazole Drug: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Effectiveness of Metronidazole Versus Homologated Placebo in Pain Control Posthemorrhoidectomy

Resource links provided by NLM:


Further study details as provided by CLOTILDE FUENTES OROZCO, Instituto Mexicano del Seguro Social:

Primary Outcome Measures:
  • Pain evolution, hours and days after surgery [ Time Frame: 6 and 12 hours, 1, 4, 7 and 14 days ]
    Pain was assessed with the visual analogue scale questionnaire


Secondary Outcome Measures:
  • Interleukin [ Time Frame: after surgery and 12 hours ]
    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 [ Time Frame: 6 and 12 hours, 1, 4, 7 and 14 days ]
    Using a questionnaire if they used analgesics, which one, dose of it and how many days

  • Surgery complications [ Time Frame: 6 and 12 hours, 1, 4, 7 and 14 days ]
    Asking directly to participants if they presented bleeding, urinary retention or another complication. Investigators measured how many participants presented complications

  • Return to normal activities [ Time Frame: 1, 4, 7 and 14 days ]
    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 [ Time Frame: 14 day ]
    Asking how they felt in last 14 days and what was their perception of the surgery


Enrollment: 44
Study Start Date: July 2013
Study Completion Date: October 2014
Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Metronidazole
22 patients received oral metronidazole 500mg 3 times for day for 7 days
Drug: Metronidazole
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
Other Name: Flagyl
Placebo Comparator: Placebo
22 patients received oral placebo 500mg 3 times for day for 7 days
Drug: Placebo
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.
Other Name: Homologated Placebo

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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Hemorrhoidal disease grade III and IV
  • Informed consent

Exclusion Criteria:

  • Pregnancy
  • Lactation
  • Other anorectal disease
  • Previous anorectal
  • hypersensibility to metronidazole
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02328144

Locations
Mexico
Western Medical Center, Mexican Institute of Social Security
Guadalajara, Jalisco, Mexico, 44340
Sponsors and Collaborators
Instituto Mexicano del Seguro Social
Investigators
Principal Investigator: Clotilde Fuentes-Orozco, PhD Instituto Mexicano del Seguro Social
  More Information

Responsible Party: CLOTILDE FUENTES OROZCO, PhD, Instituto Mexicano del Seguro Social
ClinicalTrials.gov Identifier: NCT02328144     History of Changes
Other Study ID Numbers: R-2013-1301-71
Study First Received: December 22, 2014
Last Updated: December 26, 2014

Keywords provided by CLOTILDE FUENTES OROZCO, Instituto Mexicano del Seguro Social:
Hemorrhoidectomy
Postoperative pain
Metronidazole

Additional relevant MeSH terms:
Hemorrhoids
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Vascular Diseases
Cardiovascular Diseases
Metronidazole
Anti-Infective Agents
Antiprotozoal Agents
Antiparasitic Agents

ClinicalTrials.gov processed this record on June 26, 2017