PilesNCT07481812
Prolapsed Hemorrhoids: Assessment of Various Surgical Modalities
A study testing LigaSure Hemorroidectomy, Stapled Hemorrhoidopexy and Traditional hemorroidectomy in people with Piles, run by Theodor Bilharz Research Institute at 1 site in Egypt.
Trial summary
Postoperative complications like pain, hemorrhage, anal stenosis, and incontinence, which can slow down recovery, are frequently associated with a standard hemorrhoidectomy. New procedures such the LigaSure Vessel Sealing System (LVSS) and the staplers have allowed us to perform a bloodless hemorrhoidectomy with… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Piles
- What is being tested?
- LigaSure Hemorroidectomy, Stapled Hemorrhoidopexy and Traditional hemorroidectomy
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Apr 2024to 5 Oct 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 65 years old.
- symptomatic 4th-degree primary hemorrhoids
- American Society of Anesthesiologists (ASA) I,II.
Who cannot join
- who are under the age of 18 and more than 65 years old,.
- Bleeding tendency.
- Patients with first-, second- or third-degree piles.
- Perianal fistula as an example of concurrent anal pathology.
- American Society of Anesthesiologists (ASA) III, IV, and V.
Trial locations and contacts
1 site in 1 country.
About this study
Postoperative complications like pain, hemorrhage, anal stenosis, and incontinence, which can slow down recovery, are frequently associated with a standard hemorrhoidectomy. New procedures such the LigaSure Vessel Sealing System (LVSS) and the staplers have allowed us to perform a bloodless hemorrhoidectomy with faster recovery and less postoperative discomfort.
- Conditions
- Piles
- Being tested
- LigaSure Hemorroidectomy, Stapled Hemorrhoidopexy, Traditional hemorroidectomy
- Medical subject headings
- Hemorrhoids
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LigaSure HemorroidectomyDevice
Hemorroidectomy was done using the LigaSure Vessel Sealing System (LVSS)®
Stapled HemorrhoidopexyDevice
Hemorrhoidectomy was done using the PPH stapler.
Traditional hemorroidectomyProcedure or surgery
Hemorrhoidectomy was done using the Milligan-Morgan technique
| Study group | Role | What they receive |
|---|---|---|
| LiagSure hemorroidectomy | Active comparator | Not described Receives: Device: LigaSure Hemorroidectomy |
| Stapler hemorroidopexy | Active comparator | Not described Receives: Device: Stapled Hemorrhoidopexy |
| Traditional hemorroidectomy | Active comparator | Not described Receives: Procedure: Traditional hemorroidectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
To measure the pain score and record adverse events in the three groups. pain was measured using the visual analog scale, which consists of a 10 cm horizontal line, anchored by descriptors such as "no pain" at 0 cm and "worst imaginable pain at 10 cm,"
A visual analog scale (VAS) was used to assess pain after surgery. Bleeding, discomfort, and urine retention were among the postoperative factors that were recorded. A Visual Analog Scale (VAS) is a validated, subjective, and continuous psychometric response scale used to measure intensity in areas like pain, fatigue, or mood. It typically consists of a 10 cm horizontal line, anchored by descriptors such as "no pain at 0 cm" and "worst imaginable pain at 10 cm," with patients marking their level.
Measured: 1.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2026
- Study start5 Apr 2024
- Primary completion5 Oct 2025
- Study completion5 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PilesStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Theodor Bilharz Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Rady, Theodor Bilharz Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07481812
- Sponsor's protocol ID
- PT (719)
- Status last verified
- Mar 2026
- First submitted
- 15 Mar 2026
- Last updated
- 31 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fišere, Inese, et al. "Worldwide Disease-Haemorrhoids. How much do we know?." Proceedings of the Latvian Academy of Sciences. Vol. 75. No. 1. De Gruyter Poland, 2021.
1- Nallajerla, Saikrishna, and Suhasin Ganta. "A comprehensive review on hemorrhoids a recto anal disorder." Pharmacologyonline 1 (2021): 270-282.
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prolapsed Hemorrhoids: Assessment of Various Surgical Modalities
- ClinicalTrials.gov ID
- NCT07481812
- Acronym / sponsor ID
- PT (719)
- Conditions
- Piles
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Theodor Bilharz Research InstituteUniversity, hospital or other
- Study start
- 5 Apr 2024 (actual)
- Primary completion
- 5 Oct 2025 (actual)
- Study completion
- 5 Oct 2025 (actual)
- First posted
- 19 Mar 2026 (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.
Postoperative complications like pain, hemorrhage, anal stenosis, and incontinence, which can slow down recovery, are frequently associated with a standard hemorrhoidectomy. New procedures such the LigaSure Vessel Sealing System (LVSS) and the staplers have allowed us to perform a bloodless hemorrhoidectomy with faster recovery and less postoperative discomfort.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| LiagSure hemorroidectomy | Active comparator | Device: LigaSure Hemorroidectomy |
| Stapler hemorroidopexy | Active comparator | Device: Stapled Hemorrhoidopexy |
| Traditional hemorroidectomy | Active comparator | Procedure: Traditional hemorroidectomy |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age between 18 and 65 years old.
- symptomatic 4th-degree primary hemorrhoids
- American Society of Anesthesiologists (ASA) I,II.
Key exclusion criteria (5 listed)
- who are under the age of 18 and more than 65 years old,.
- Bleeding tendency.
- Patients with first-, second- or third-degree piles.
- Perianal fistula as an example of concurrent anal pathology.
- American Society of Anesthesiologists (ASA) III, IV, and V.
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 |
|---|---|---|
| LigaSure HemorroidectomyHemorroidectomy was done using the LigaSure Vessel Sealing System (LVSS)® | Device | LiagSure hemorroidectomy |
| Stapled HemorrhoidopexyHemorrhoidectomy was done using the PPH stapler. | Device | Stapler hemorroidopexy |
| Traditional hemorroidectomyHemorrhoidectomy was done using the Milligan-Morgan technique | Procedure or surgery | Traditional hemorroidectomy |
Primary outcome
To measure the pain score and record adverse events in the three groups. pain was measured using the visual analog scale, which consists of a 10 cm horizontal line, anchored by descriptors such as "no pain" at 0 cm and "worst imaginable pain at 10 cm,"
Time frame: 1.5 years
A visual analog scale (VAS) was used to assess pain after surgery. Bleeding, discomfort, and urine retention were among the postoperative factors that were recorded. A Visual Analog Scale (VAS) is a validated, subjective, and continuous psychometric response scale used to measure intensity in areas like pain, fatigue, or mood. It typically consists of a 10 cm horizontal line, anchored by descriptors such as "no pain at 0 cm" and "worst imaginable pain at 10 cm," with patients marking their level.
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 Mar 2026.
- BackgroundFišere, Inese, et al. "Worldwide Disease-Haemorrhoids. How much do we know?." Proceedings of the Latvian Academy of Sciences. Vol. 75. No. 1. De Gruyter Poland, 2021.
- Background1- Nallajerla, Saikrishna, and Suhasin Ganta. "A comprehensive review on hemorrhoids a recto anal disorder." Pharmacologyonline 1 (2021): 270-282.
- 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 LigaSure Hemorroidectomy, Stapled Hemorrhoidopexy and Traditional hemorroidectomy in people with Piles, run by Theodor Bilharz Research Institute 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 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 Mar 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?
To measure the pain score and record adverse events in the three groups. pain was measured using the visual analog scale, which consists of a 10 cm horizontal line, anchored by descriptors such as "no pain" at 0 cm and "worst imaginable pain at 10 cm," (time frame: 1.5 years). 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 NCT07481812, which also lists 2 linked publications.
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 Mar 2026.