HemorrhoidsPhase 3NCT02328144
Effectiveness of Metronidazole in Pain Control Posthemorrhoidectomy
A Phase 3 study testing Metronidazole in people with Hemorrhoids, run by Instituto Mexicano del Seguro Social at 1 site in Mexico.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemorrhoids
- What is being tested?
- Metronidazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteMexico
- Study dates
- Jul 2013to Oct 2014
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hemorrhoidal disease grade III and IV
- Informed consent
Who cannot join
- Pregnancy
- Lactation
- Other anorectal disease
- Previous anorectal
- hypersensibility to metronidazole
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Western Medical Center, Mexican Institute of Social Security
Guadalajara, Jalisco, 44340
About this study
Official title: Effectiveness of Metronidazole Versus Homologated Placebo in Pain Control Posthemorrhoidectomy
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
Read the 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
- Conditions
- Hemorrhoids
- Being tested
- Metronidazole, Placebo
- Keywords
- Hemorrhoidectomy, Postoperative pain, Metronidazole
- Medical subject headings
- Hemorrhoids, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetronidazoleDrug
Also called Flagyl
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
PlaceboDrug
Also called Homologated 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.
| Study group | Role | What they receive |
|---|---|---|
| Metronidazole | Active comparator | 22 patients received oral metronidazole 500mg 3 times for day for 7 days Receives: Drug: Metronidazole |
| Placebo | Placebo comparator | 22 patients received oral placebo 500mg 3 times for day for 7 days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain evolution, hours and days after surgery
Pain was assessed with the visual analogue scale questionnaire
Measured: 6 and 12 hours, 1, 4, 7 and 14 days
Secondary outcomes (5)
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
Measured: after surgery and 12 hours
Analgesics
Using a questionnaire if they used analgesics, which one, dose of it and how many days
Measured: 6 and 12 hours, 1, 4, 7 and 14 days
Surgery complications
Asking directly to participants if they presented bleeding, urinary retention or another complication. Investigators measured how many participants presented complications
Measured: 6 and 12 hours, 1, 4, 7 and 14 days
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
Measured: 1, 4, 7 and 14 days
Satisfaction
Asking how they felt in last 14 days and what was their perception of the surgery
Measured: 14 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2014 (estimated)
- Study startJul 2013
- Primary completionAug 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemorrhoidsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Mexicano del Seguro Social
- Sponsor type
- Other government
- Responsible party
- Principal investigator, CLOTILDE FUENTES OROZCO, Instituto Mexicano del Seguro Social
- Investigators
- Clotilde Fuentes-Orozco, PhD, Principal investigator, Instituto Mexicano del Seguro Social
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02328144
- Sponsor's protocol ID
- R-2013-1301-71
- Status last verified
- Dec 2014
- First submitted
- 22 Dec 2014
- Last updated
- 31 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Metronidazole Versus Homologated Placebo in Pain Control Posthemorrhoidectomy
- ClinicalTrials.gov ID
- NCT02328144
- Acronym / sponsor ID
- R-2013-1301-71
- Conditions
- Hemorrhoids
- Keywords
- Hemorrhoidectomy, Postoperative pain, Metronidazole
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Instituto Mexicano del Seguro SocialOther government
- Study start
- Jul 2013
- Primary completion
- Aug 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 31 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Metronidazole | Active comparator | Drug: Metronidazole22 patients received oral metronidazole 500mg 3 times for day for 7 days |
| Placebo | Placebo comparator | Drug: Placebo22 patients received oral placebo 500mg 3 times for day for 7 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Hemorrhoidal disease grade III and IV
- Informed consent
Key exclusion criteria (5 listed)
- Pregnancy
- Lactation
- Other anorectal disease
- Previous anorectal
- hypersensibility to metronidazole
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MetronidazoleAlso: FlagylPatients 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 | Drug | Metronidazole |
| PlaceboAlso: Homologated PlaceboPatients 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. | Drug | Placebo |
Primary outcome
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
5 secondary outcomes
Interleukin
Time frame: after surgery and 12 hours
Analgesics
Time frame: 6 and 12 hours, 1, 4, 7 and 14 days
Surgery complications
Time frame: 6 and 12 hours, 1, 4, 7 and 14 days
Return to normal activities
Time frame: 1, 4, 7 and 14 days
Satisfaction
Time frame: 14 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clotilde Fuentes-Orozco, PhD principal investigator
Instituto Mexicano del Seguro Social
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Metronidazole in people with Hemorrhoids, run by Instituto Mexicano del Seguro Social at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain evolution, hours and days after surgery (time frame: 6 and 12 hours, 1, 4, 7 and 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2014.