Lateral Internal SphincterotomyNCT06884774
Hemorrhoidectomy With or Without Lateral Internal Sphincterotomy in Management of Patients With Hemorrhoids
A study testing Hemorrhoidectomy with lateral internal sphincterotomy and Hemorrhoidectomy in people with Lateral Internal Sphincterotomy and Hemorrhoidectomy, run by Minia University at 1 site in Egypt.
Trial summary
This study aims to compare the lateral internal sphincterotomy versus no lateral internal sphincterotomy during hemorrhoidectomy in the management of patients with hemorrhoids. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Lateral Internal Sphincterotomy, Hemorrhoidectomy, Hemorrhoids
- What is being tested?
- Hemorrhoidectomy with lateral internal sphincterotomy and Hemorrhoidectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Dec 2024to 1 Dec 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age above 18 years old.
- Both sexes.
- All patients indicated for surgical Hemorrhoidectomy (2nd, 3rd, and 4th degree piles).
Who cannot join
- Patients with 1st degree piles.
- Patients with piles plus fissure.
- Age above 70 years old
- Unfit for surgery.
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to compare the lateral internal sphincterotomy versus no lateral internal sphincterotomy during hemorrhoidectomy in the management of patients with hemorrhoids.
Read the detailed description
Hemorrhoidectomy is associated with postoperative pain, and no single surgical technique has been proven to reduce the pain significantly.
However, there are many drawbacks to such techniques, such as postoperative pain and constipation. The cause of this postoperative pain is multifactorial. Spasm of the internal anal sphincter (IAS) is one of the factors which is exposed and impinged after EH. Therefore, Lateral internal sphincterotomy (LIS) is a widely used adjunct treatment after EH, which can abolish spasms of the IAS and subsequently relieve postoperative pain.
- Being tested
- Hemorrhoidectomy with lateral internal sphincterotomy, Hemorrhoidectomy
- Medical subject headings
- Hemorrhoids
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hemorrhoidectomy with lateral internal sphincterotomyProcedure or surgery
Patients undergoing Hemorrhoidectomy with lateral internal sphincterotomy.
HemorrhoidectomyProcedure or surgery
Patients undergoing Hemorrhoidectomy without lateral internal sphincterotomy.
| Study group | Role | What they receive |
|---|---|---|
| Lateral internal sphincterotomy group | Experimental | Patients undergoing Hemorrhoidectomy with lateral internal sphincterotomy. Receives: Procedure: Hemorrhoidectomy with lateral internal sphincterotomy |
| Control group | Active comparator | Patients undergoing Hemorrhoidectomy without lateral internal sphincterotomy. Receives: Procedure: Hemorrhoidectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anal pain score
The pain was measured by visual analog scoring (VAS) described as : 0-no pain, at score 1 to 3- mild pain, score 4 to 6-moderate pain, at score 7 to 10- severe pain. Post-operative pain was observed on subsequent visits after 48 hours, one week and 4 weeks postoperatively.
Measured: 4 weeks postoperatively
Secondary outcomes (1)
Degree of incontinence
Incontinence was assessed by Wexner's incontinence score for solid, liquid, and gas until 48 hours postoperatively
Measured: 48 hours postoperatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2025
- Study start20 Dec 2024
- Primary completion1 Sep 2025
- Study completion1 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lateral Internal SphincterotomyStudies of the same condition, open and under way.
- More trials run by Minia 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
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdelrahman Mohamed Salah, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06884774
- Sponsor's protocol ID
- 1230/08/2024
- Status last verified
- Jan 2026
- First submitted
- 13 Mar 2025
- Last updated
- 3 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Publications
Abdelrahman, W.M., Ali, D. & Salah, A.M. Effect of Lateral Internal Sphincterotomy on Postoperative Pain and Anal Continence After Hemorrhoidectomy: A Randomized Controlled Open-Label Trial. Indian J Surg (2026). https://doi.org/10.1007/s12262-026-04572-4
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hemorrhoidectomy With or Without Lateral Internal Sphincterotomy in Management of Patients With Hemorrhoids
- ClinicalTrials.gov ID
- NCT06884774
- Acronym / sponsor ID
- 1230/08/2024
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 20 Dec 2024 (actual)
- Primary completion
- 1 Sep 2025 (actual)
- Study completion
- 1 Dec 2025 (actual)
- First posted
- 19 Mar 2025 (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.
This study aims to compare the lateral internal sphincterotomy versus no lateral internal sphincterotomy during hemorrhoidectomy in the management of patients with hemorrhoids.
Detailed description
Hemorrhoidectomy is associated with postoperative pain, and no single surgical technique has been proven to reduce the pain significantly.
However, there are many drawbacks to such techniques, such as postoperative pain and constipation. The cause of this postoperative pain is multifactorial. Spasm of the internal anal sphincter (IAS) is one of the factors which is exposed and impinged after EH. Therefore, Lateral internal sphincterotomy (LIS) is a widely used adjunct treatment after EH, which can abolish spasms of the IAS and subsequently relieve postoperative pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lateral internal sphincterotomy group | Experimental | Procedure: Hemorrhoidectomy with lateral internal sphincterotomyPatients undergoing Hemorrhoidectomy with lateral internal sphincterotomy. |
| Control group | Active comparator | Procedure: HemorrhoidectomyPatients undergoing Hemorrhoidectomy without lateral internal sphincterotomy. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age above 18 years old.
- Both sexes.
- All patients indicated for surgical Hemorrhoidectomy (2nd, 3rd, and 4th degree piles).
Key exclusion criteria (4 listed)
- Patients with 1st degree piles.
- Patients with piles plus fissure.
- Age above 70 years old
- Unfit for 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 |
|---|---|---|
| Hemorrhoidectomy with lateral internal sphincterotomyPatients undergoing Hemorrhoidectomy with lateral internal sphincterotomy. | Procedure or surgery | Lateral internal sphincterotomy group |
| HemorrhoidectomyPatients undergoing Hemorrhoidectomy without lateral internal sphincterotomy. | Procedure or surgery | Control group |
Primary outcome
Anal pain score
Time frame: 4 weeks postoperatively
The pain was measured by visual analog scoring (VAS) described as : 0-no pain, at score 1 to 3- mild pain, score 4 to 6-moderate pain, at score 7 to 10- severe pain. Post-operative pain was observed on subsequent visits after 48 hours, one week and 4 weeks postoperatively.
1 secondary outcome
Degree of incontinence
Time frame: 48 hours postoperatively.
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 3 Sep 2026.
- Results publicationAbdelrahman, W.M., Ali, D. & Salah, A.M. Effect of Lateral Internal Sphincterotomy on Postoperative Pain and Anal Continence After Hemorrhoidectomy: A Randomized Controlled Open-Label Trial. Indian J Surg (2026). https://doi.org/10.1007/s12262-026-04572-4
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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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 Hemorrhoidectomy with lateral internal sphincterotomy and Hemorrhoidectomy in people with Lateral Internal Sphincterotomy and Hemorrhoidectomy, run by Minia 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 3 inclusion and 4 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 3 Sep 2026. 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?
Anal pain score (time frame: 4 weeks postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06884774, which also lists 1 linked publication.
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 3 Sep 2026.