Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02328144
Other study ID # R-2013-1301-71
Secondary ID
Status Completed
Phase Phase 3
First received December 22, 2014
Last updated December 26, 2014
Start date July 2013
Est. completion date October 2014

Study information

Verified date December 2014
Source Instituto Mexicano del Seguro Social
Contact n/a
Is FDA regulated No
Health authority Mexico: Ministry of Health
Study type Interventional

Clinical Trial 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


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


Recruitment information / eligibility

Status Completed
Enrollment 44
Est. completion date October 2014
Est. primary completion date August 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Hemorrhoidal disease grade III and IV

- Informed consent

Exclusion Criteria:

- Pregnancy

- Lactation

- Other anorectal disease

- Previous anorectal

- hypersensibility to metronidazole

Study Design

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


Related Conditions & MeSH terms


Intervention

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
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.

Locations

Country Name City State
Mexico Western Medical Center, Mexican Institute of Social Security Guadalajara Jalisco

Sponsors (1)

Lead Sponsor Collaborator
Instituto Mexicano del Seguro Social

Country where clinical trial is conducted

Mexico, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Yes
Secondary 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 after surgery and 12 hours Yes
Secondary Analgesics Using a questionnaire if they used analgesics, which one, dose of it and how many days 6 and 12 hours, 1, 4, 7 and 14 days Yes
Secondary Surgery complications Asking directly to participants if they presented bleeding, urinary retention or another complication. Investigators measured how many participants presented complications 6 and 12 hours, 1, 4, 7 and 14 days Yes
Secondary 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 1, 4, 7 and 14 days Yes
Secondary Satisfaction Asking how they felt in last 14 days and what was their perception of the surgery 14 day Yes
See also
  Status Clinical Trial Phase
Completed NCT06216223 - Laser Versus Surgery in Anal Diseases in Inflammatory Bowel Patients N/A
Withdrawn NCT02851940 - Pain and Bleeding Following Hypertonic Saline Sclerotherapy Compared to Brand Ligation for Symptomatic Hemorrhoids N/A
Recruiting NCT02301052 - Evaluation of Allium Ampeloprasum Spp.Iranicum Cream Effect for the Management of Hemorrhoids Symptoms Phase 1/Phase 2
Completed NCT02216305 - HAL-RAR Versus Hemorrhoidectomy in the Treatment of Grade III-IV Hemorrhoids. Prospective, Randomized Trial N/A
Completed NCT02358174 - Hemorrhoids and Metalloproteinases, Observational Study N/A
Completed NCT01483833 - Efficacy Study of Iferanserin to Treat Hemorrhoids Phase 2
Completed NCT00397137 - Stapled Anopexy Versus Closed Haemorrhoidectomy for Haemorrhoids N/A
Completed NCT00841620 - Symptom Control 1-year After Circular Stapler Anopexy or Diathermy Excision for Prolapsed Haemorhoids Phase 4
Completed NCT06459739 - Effect of Sacral Erector Spinae Plane Block on Hemorrhoid and Pilonidal Sinus Surgery N/A
Completed NCT04276298 - Topical Analgesia Post-Haemorrhoidectomy Phase 2/Phase 3
Completed NCT04675177 - Polidocanol Foam VS Artery Ligation in Hemorrhoidal Disease Phase 2/Phase 3
Recruiting NCT05889962 - Ultrasound-guided Pudendal Nerve Block for Pain After Hemorrhoidectomy N/A
Recruiting NCT01961739 - Topical 2% Lidocaine for the Treatment of Symptomatic Hemorrhoids Phase 2/Phase 3
Active, not recruiting NCT02061176 - THD Versus Open Haemorrhoidectomy N/A
Withdrawn NCT00512044 - Local Versus General Anaesthesia in Stapled Hemorrhoidectomy Phase 4
Completed NCT04031131 - The Use of Topical Anaesthetic in the Banding of Internal Haemorrhoids Phase 2
Recruiting NCT04329364 - RCT Comparing Conventional Haemorrhoidectomy With Laser Haemorrhoidoplasty Phase 2/Phase 3
Completed NCT04567485 - Impact of Moderate to Severe Pain in the Post-intervention Monitoring Room After Hemorrhoidectomy on the Length of Stay in the Outpatient Surgery Unit
Completed NCT05247333 - Implementation of a Minor Ailment Service in Community Pharmacy Practice N/A
Completed NCT03298997 - Ligation and Hemorrhoidopexy Technique Versus Ligation of Hemorrhoidal Arteries Using Ultrasound for Hemorrhoids N/A