HemorrhoidsNCT06588374
Hemorrhoidectomy Only Versus Hemorrhoidectomy With Lateral Internal Sphincterotomy
A study testing lateral internal sphincterotomy in people with Hemorrhoids, run by Assiut University.
Trial summary
The aim of this study was to access the comparison of pain and complications after hemorrhoidectomy with or without lateral sphincterotomy. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Hemorrhoids
- What is being tested?
- lateral internal sphincterotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 31 Aug 2024to 1 Aug 2025
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Surgically fit according to ASA.
- Cases with hemorrhoids Grade ll\& III \& IV.
- Age between (18-60).
Who cannot join
- Age less than 18 years old.
- Complete rectal prolapse.
- Grade I hemorrhoids.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Effect of Lateral Internal Sphincterotomy During Hemorrhoidectomy ,a Randomized Clinical Trial.
The aim of this study was to access the comparison of pain and complications after hemorrhoidectomy with or without lateral sphincterotomy.
Read the detailed description
Hemorrhoids arise from congestion of anal cushions and characteristically lie in the 3, 7 and 11 O clock positions (with the patient in lithotomy position) . The most common complication of open hemorrhoidectomy is postoperative pain caused by spasm of the internal sphincter . Lateral internal sphincterotomy is one good technique. It reduces pain by reducing spasm of internal anal sphincter which is the main cause of pain . The addition of lateral internal sphincterotomy to haemorrhoidectomy resulted in generally lower postoperative anal pressures . The long-term outcomes, which included anal stenosis and anal fissure, were significantly lower after lateral internal sphincterotomy . patients with recurrence of hemorrhoids, severe pain, prolonged constipation, or anyone with high sphincter tonicity in the digital rectal examination would be a candidate for manometric evaluation of anal canal pressure. These patients with high analcanal pressure confirmed with manometry might receive internal sphincterotomy plus hemorrhoid-ectomy .
- Conditions
- Hemorrhoids
- Being tested
- lateral internal sphincterotomy
- Medical subject headings
- Hemorrhoids
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lateral internal sphincterotomyProcedure or surgery
Hemorrhoidectomy versus Hemorrhoidectomy with lateral internal sphincterotomy
| Study group | Role | What they receive |
|---|---|---|
| Hemorrhoidectomy Only | Experimental | Hemorrhoids by Hemorrhoidectomy alone Receives: Procedure: lateral internal sphincterotomy |
| Hemorrhoidectomy With Lateral Internal Sphincterotomy | Experimental | hemorroids by lateral internal sphincterotomy and hemorrhoidectomy Receives: Procedure: lateral internal sphincterotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of Hemorrhoidectomy versus Hemorrhoidectomy with lateral internal sphincterotomy on post operative complications
To assess postoperative pain intensity by Numberical rating scale 0 To 10
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start31 Aug 2024 (estimated)
- Primary completion1 Mar 2025 (estimated)
- Study completion1 Aug 2025 (estimated)
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 Assiut 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- hemorrhoidectomy alone versus hemorrhoidectomy with lateral internal sphincterotomy
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Mamdouh Mohamed Ahmed, Assiut University
- Investigators
- ashraf A Helmy, professor, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06588374
- Sponsor's protocol ID
- Hemorrhoidectomy
- Status last verified
- Sep 2024
- First submitted
- 26 Feb 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Lateral Internal Sphincterotomy During Hemorrhoidectomy ,a Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT06588374
- Acronym / sponsor ID
- Hemorrhoidectomy
- Conditions
- Hemorrhoids
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 31 Aug 2024 (estimated)
- Primary completion
- 1 Mar 2025 (estimated)
- Study completion
- 1 Aug 2025 (estimated)
- First posted
- 19 Sep 2024 (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.
The aim of this study was to access the comparison of pain and complications after hemorrhoidectomy with or without lateral sphincterotomy.
Detailed description
Hemorrhoids arise from congestion of anal cushions and characteristically lie in the 3, 7 and 11 O clock positions (with the patient in lithotomy position) . The most common complication of open hemorrhoidectomy is postoperative pain caused by spasm of the internal sphincter . Lateral internal sphincterotomy is one good technique. It reduces pain by reducing spasm of internal anal sphincter which is the main cause of pain . The addition of lateral internal sphincterotomy to haemorrhoidectomy resulted in generally lower postoperative anal pressures . The long-term outcomes, which included anal stenosis and anal fissure, were significantly lower after lateral internal sphincterotomy . patients with recurrence of hemorrhoids, severe pain, prolonged constipation, or anyone with high sphincter tonicity in the digital rectal examination would be a candidate for manometric evaluation of anal canal pressure. These patients with high analcanal pressure confirmed with manometry might receive internal sphincterotomy plus hemorrhoid-ectomy .
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- hemorrhoidectomy alone versus hemorrhoidectomy with lateral internal sphincterotomy
| Arm | Type | Receives |
|---|---|---|
| Hemorrhoidectomy Only | Experimental | Procedure: lateral internal sphincterotomyHemorrhoids by Hemorrhoidectomy alone |
| Hemorrhoidectomy With Lateral Internal Sphincterotomy | Experimental | Procedure: lateral internal sphincterotomyhemorroids by lateral internal sphincterotomy and hemorrhoidectomy |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Surgically fit according to ASA.
- Cases with hemorrhoids Grade ll\& III \& IV.
- Age between (18-60).
Key exclusion criteria (3 listed)
- Age less than 18 years old.
- Complete rectal prolapse.
- Grade I hemorrhoids.
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 |
|---|---|---|
| lateral internal sphincterotomyHemorrhoidectomy versus Hemorrhoidectomy with lateral internal sphincterotomy | Procedure or surgery | Hemorrhoidectomy Only, Hemorrhoidectomy With Lateral Internal Sphincterotomy |
Primary outcome
Effect of Hemorrhoidectomy versus Hemorrhoidectomy with lateral internal sphincterotomy on post operative complications
Time frame: Baseline
To assess postoperative pain intensity by Numberical rating scale 0 To 10
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- The Role of Lateral Internal Sphincterotomy in Haemorrhoidectomy: A Study in a Tertiary Care CenterLink provided by the sponsor.
- Comparison of hemorrhoidectomy combined with LIS and open hemorrhoidectomyLink provided by the sponsor.
- Randomized controlled trial of lateral internal sphincterotomy with haemorrhoidectomyLink provided by the sponsor.
- The Role of Lateral Internal Sphincterotomy in Haemorrhoidectomy: A Study in a Tertiary Care CenterLink provided by the sponsor.
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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.
ashraf A Helmy, professor principal investigator
Assiut University
Questions about this trial
What is this clinical trial studying?
A study testing lateral internal sphincterotomy in people with Hemorrhoids, run by Assiut University.
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 3 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: status not confirmed, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohamed M Mohamed, Resident (01151229424, 01024691101mm@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of Hemorrhoidectomy versus Hemorrhoidectomy with lateral internal sphincterotomy on post operative complications (time frame: Baseline). 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 19 Sep 2024.