HemorrhoidsNCT03036111
Effect of Topical Trimebutine on Pain After Hemorrhoidectomy
A study testing Trimebutine and Hemorrhoidectomy in people with Hemorrhoids, run by Mansoura University at 1 site in Egypt.
Trial summary
Trimebutine acts through smooth muscle relaxation. It is presumed that the topical application of trimebutine after hemorrhoidectomy may help relieve pain after the procedure by relaxing the internal anal sphincter spasm. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hemorrhoids
- What is being tested?
- Trimebutine and Hemorrhoidectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2017to 1 Apr 2018
- 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
- Patients of both genders aging between 18-70 years with grade III/VI internal hemorrhoids will be included
Who cannot join
- Patients with grade I/II internal hemorrhoids or external hemorrhoids.
- Patients with associated anorectal pathology such as anal fissure, anal fistula, rectal prolapse, neoplasm, solitary rectal ulcer, and inflammatory bowel diseases.\
- Patients with recurrent hemorrhoids after previous surgery.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Trimebutine on Postoperative Pain After Milligan-Morgan Hemorrhoidectomy: A Randomized Controlled Trial
Trimebutine acts through smooth muscle relaxation. It is presumed that the topical application of trimebutine after hemorrhoidectomy may help relieve pain after the procedure by relaxing the internal anal sphincter spasm.
Read the detailed description
A randomized trial will be carried out to investigate the effect of trimebutine on pain after Milligan-Morgan hemorrhoidectomy. Trimebutine relaxes the internal anal sphincter spasm which usually occurs after excisional hemorrhoidectomy.
- Conditions
- Hemorrhoids
- Being tested
- Trimebutine, Hemorrhoidectomy
- Medical subject headings
- Hemorrhoids
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TrimebutineDrug
Also called Gastreg suppository
Trimebutine suppository will be inserted in the anal canal on completion of hemorrhoidectomy then at six and 12 hours postoperatively.
HemorrhoidectomyProcedure or surgery
Patients will undergo classic Milliagn-Morgan hemorrhoidectomy
| Study group | Role | What they receive |
|---|---|---|
| Hemorrhoidectomy | Sham comparator | Patients will undergo Millgan-Morgan hemorrhoidectomy as classically described before Receives: Procedure: Hemorrhoidectomy |
| trimebutine | Active comparator | Patients will undergo Millgan-Morgan hemorrhoidectomy then triembutine suppository will be inserted in the anal canal intraoperatively and then every six hours for 24 hours. Receives: Drug: Trimebutine; Procedure: Hemorrhoidectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain assessment assessed using visual analogue score from 0-10
Anal pain will be assessed using visual analogue score from 0-10
Measured: Pain will be assessed at 12 hours after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2017 (estimated)
- Study start1 Feb 2017
- Primary completion1 Feb 2018 (estimated)
- Study completion1 Apr 2018 (estimated)
Why it stopped: Unavailability of Triembutine maleate
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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sameh Emile, Mansoura University
- Investigators
- Sameh H Emile, M.D., Principal investigator, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03036111
- Sponsor's protocol ID
- mansourau20172
- Status last verified
- Jan 2017
- First submitted
- 24 Jan 2017
- Last updated
- 29 Aug 2017
- 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 29 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Trimebutine on Postoperative Pain After Milligan-Morgan Hemorrhoidectomy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03036111
- Acronym / sponsor ID
- mansourau20172
- Conditions
- Hemorrhoids
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Unavailability of Triembutine maleate
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 1 Feb 2018 (estimated)
- Study completion
- 1 Apr 2018 (estimated)
- First posted
- 30 Jan 2017 (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.
Trimebutine acts through smooth muscle relaxation. It is presumed that the topical application of trimebutine after hemorrhoidectomy may help relieve pain after the procedure by relaxing the internal anal sphincter spasm.
Detailed description
A randomized trial will be carried out to investigate the effect of trimebutine on pain after Milligan-Morgan hemorrhoidectomy. Trimebutine relaxes the internal anal sphincter spasm which usually occurs after excisional hemorrhoidectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hemorrhoidectomy | Sham comparator | Procedure: HemorrhoidectomyPatients will undergo Millgan-Morgan hemorrhoidectomy as classically described before |
| trimebutine | Active comparator | Drug: Trimebutine, Procedure: HemorrhoidectomyPatients will undergo Millgan-Morgan hemorrhoidectomy then triembutine suppository will be inserted in the anal canal intraoperatively and then every six hours for 24 hours. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients of both genders aging between 18-70 years with grade III/VI internal hemorrhoids will be included
Key exclusion criteria (3 listed)
- Patients with grade I/II internal hemorrhoids or external hemorrhoids.
- Patients with associated anorectal pathology such as anal fissure, anal fistula, rectal prolapse, neoplasm, solitary rectal ulcer, and inflammatory bowel diseases.\
- Patients with recurrent hemorrhoids after previous surgery.
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 |
|---|---|---|
| TrimebutineAlso: Gastreg suppositoryTrimebutine suppository will be inserted in the anal canal on completion of hemorrhoidectomy then at six and 12 hours postoperatively. | Drug | trimebutine |
| HemorrhoidectomyPatients will undergo classic Milliagn-Morgan hemorrhoidectomy | Procedure or surgery | Hemorrhoidectomy, trimebutine |
Primary outcome
Pain assessment assessed using visual analogue score from 0-10
Time frame: Pain will be assessed at 12 hours after the procedure
Anal pain will be assessed using visual analogue score from 0-10
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2017.
- 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.
Sameh H Emile, M.D. principal investigator
Mansoura University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trimebutine and Hemorrhoidectomy in people with Hemorrhoids, 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 1 inclusion and 3 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: paused, as of the sponsor's last update on 29 Aug 2017. 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. 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.
Are results available for this study?
Results are not available in the source record.
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 assessment assessed using visual analogue score from 0-10 (time frame: Pain will be assessed at 12 hours after the procedure). 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 29 Aug 2017.