HemorrhoidsNCT05038605
Topical vs Oral Metronidazole After Benign Anorectal Surgery
A study testing Topical metronidazole and oral metronidazole in people with Hemorrhoids and Anal Fissure, run by Mansoura University at 1 site in Egypt.
Trial summary
While some investigators found oral metronidazole to be effective in reducing pain after hemorrhoidectomy, other researchers did not find a significant analgesic effect of systemic metronidazole. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hemorrhoids, Anal Fissure, Anal Fistula
- What is being tested?
- Topical metronidazole and oral metronidazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteEgypt
- Study dates
- 24 Jan 2020to 1 Mar 2021
- Phase
- Interventional
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients of either sex aged below 70 years
- Underwent surgery for hemorrhoids, anal fissure, or simple anal fistula.
Who cannot join
- Grade I-II hemorrhoids.
- acute anal fissure.
- complex anal fistula
- perianal abscess
- perianal Crohn's disease
- malignancy.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Mansoura university hospital
Al Mansurah, Dakahlia Governorate, 35516
About this study
Official title: Topical Versus Oral Metronidazole for Pain Relief After Surgery for Benign Anorectal Conditions; a Prospective Randomized Study
While some investigators found oral metronidazole to be effective in reducing pain after hemorrhoidectomy, other researchers did not find a significant analgesic effect of systemic metronidazole. On the other hand, topical application of metronidazole had more consistent favorable results as Ala et al documented a remarkable analgesic effect of topical metronidazole 10% after excisional hemorrhoidectomy which was in line with Nicholson and Armestrong who also concluded similar results.
No previous study compared the analgesic effect of topical and oral metronidazole after anorectal surgery. Therefore, the present trial was conducted to compare the impact of oral versus systemic metronidazole on pain and recovery after surgery for benign anorectal conditions.
- Conditions
- Hemorrhoids, Anal Fissure, Anal Fistula
- Being tested
- Topical metronidazole, oral metronidazole
- Medical subject headings
- Hemorrhoids, Fissure in Ano, Rectal Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topical metronidazoleDrug
Topical application of metronidazole cream on the anal verge every 8 hours after surgery
oral metronidazoleDrug
Patients received oral metronidazole 500 mg tablets every 8 hours after surgery
| Study group | Role | What they receive |
|---|---|---|
| Topical metronidazole | Active comparator | Topical application of metronidazole cream on the anal verge after surgery Receives: Drug: Topical metronidazole |
| Oral metronidazole | Active comparator | oral metronidazole 500 mg tablets after surgery Receives: Drug: oral metronidazole |
| Control | No intervention | No metronidazole was received |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain score
Pain was assessed using visual analogue scale form 0 to 10, higher score indicates worse pain
Measured: at one day after surgery
Postoperative pain score
Pain was assessed using visual analogue scale form 0 to 10, higher score indicates worse pain
Measured: at two days after surgery
Postoperative pain score
Pain was assessed using visual analogue scale form 0 to 10, higher score indicates worse pain
Measured: at seven days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2021
- Study start24 Jan 2020
- Primary completion30 Jan 2021
- Study completion1 Mar 2021
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.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sameh Emile, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05038605
- Sponsor's protocol ID
- Mansoura2021
- Status last verified
- Aug 2021
- First submitted
- 29 Aug 2021
- Last updated
- 9 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Topical Versus Oral Metronidazole for Pain Relief After Surgery for Benign Anorectal Conditions; a Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT05038605
- Acronym / sponsor ID
- Mansoura2021
- Conditions
- Hemorrhoids, Anal Fissure, Anal Fistula
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 24 Jan 2020 (actual)
- Primary completion
- 30 Jan 2021 (actual)
- Study completion
- 1 Mar 2021 (actual)
- First posted
- 9 Sep 2021 (actual)
- 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.
While some investigators found oral metronidazole to be effective in reducing pain after hemorrhoidectomy, other researchers did not find a significant analgesic effect of systemic metronidazole. On the other hand, topical application of metronidazole had more consistent favorable results as Ala et al documented a remarkable analgesic effect of topical metronidazole 10% after excisional hemorrhoidectomy which was in line with Nicholson and Armestrong who also concluded similar results.
No previous study compared the analgesic effect of topical and oral metronidazole after anorectal surgery. Therefore, the present trial was conducted to compare the impact of oral versus systemic metronidazole on pain and recovery after surgery for benign anorectal conditions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Topical metronidazole | Active comparator | Drug: Topical metronidazoleTopical application of metronidazole cream on the anal verge after surgery |
| Oral metronidazole | Active comparator | Drug: oral metronidazoleoral metronidazole 500 mg tablets after surgery |
| Control | No intervention | –No metronidazole was received |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult patients of either sex aged below 70 years
- Underwent surgery for hemorrhoids, anal fissure, or simple anal fistula.
Key exclusion criteria (6 listed)
- Grade I-II hemorrhoids.
- acute anal fissure.
- complex anal fistula
- perianal abscess
- perianal Crohn's disease
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 |
|---|---|---|
| Topical metronidazoleTopical application of metronidazole cream on the anal verge every 8 hours after surgery | Drug | Topical metronidazole |
| oral metronidazolePatients received oral metronidazole 500 mg tablets every 8 hours after surgery | Drug | Oral metronidazole |
Primary outcome
Postoperative pain score
Time frame: at one day after surgery
Pain was assessed using visual analogue scale form 0 to 10, higher score indicates worse pain
Postoperative pain score
Time frame: at two days after surgery
Pain was assessed using visual analogue scale form 0 to 10, higher score indicates worse pain
Postoperative pain score
Time frame: at seven days after surgery
Pain was assessed using visual analogue scale form 0 to 10, higher score indicates worse pain
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 9 Sep 2021.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Topical metronidazole and oral metronidazole in people with Hemorrhoids and Anal Fissure, run by Mansoura University at 1 site in Egypt.
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 6 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 9 Sep 2021. 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 Egypt. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Postoperative pain score (time frame: at one day after surgery). The study lists 3 primary outcomes in all. 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 9 Sep 2021.