Postoperative PainNCT07710053
Postoperative Pain and Tenesmus After Doppler-Guided Hemorrhoidal Artery Ligation With or Without Mucopexy
A study testing HAL + Mucopexy and HAL Alone in people with Postoperative Pain, run by Ali Genc.
Trial summary
Hemorrhoidal disease is one of the most common anorectal disorders affecting adults worldwide. Doppler-guided hemorrhoidal artery ligation (HAL) is a minimally invasive surgical technique that has gained popularity because of its lower postoperative pain and faster recovery compared with conventional hemorrhoidectomy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- HAL + Mucopexy and HAL Alone
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2026to Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years
- Diagnosis of hemorrhoidal disease requiring surgical treatment
- Ability to provide written informed consent
- Willingness to participate in the study.
Who cannot join
- Age below 18 years
- Presence of other anal canal diseases (anal fissure, anal fistula, anorectal malignancy, inflammatory bowel disease involving the anorectal region, etc.)
- Previous anorectal surgery that may affect study outcomes
- Inability or unwillingness to provide informed consent.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Comparison of Postoperative Pain and Tenesmus Between Doppler-Guided Hemorrhoidal Artery Ligation Alone and Doppler-Guided Hemorrhoidal Artery Ligation Combined With Mucopexy in Patients With Hemorrhoidal Disease
Hemorrhoidal disease is one of the most common anorectal disorders affecting adults worldwide. Doppler-guided hemorrhoidal artery ligation (HAL) is a minimally invasive surgical technique that has gained popularity because of its lower postoperative pain and faster recovery compared with conventional hemorrhoidectomy. In selected patients, HAL may be combined with mucopexy to address prolapsing hemorrhoidal tissue.
The aim of this prospective study is to compare postoperative pain and tenesmus between patients undergoing Doppler-guided hemorrhoidal artery ligation alone and those undergoing Doppler-guided hemorrhoidal artery ligation combined with mucopexy.
Read more
Patients diagnosed with hemorrhoidal disease and scheduled for surgical treatment at the General Surgery Department of Tokat Gaziosmanpaşa University Hospital will be enrolled after obtaining ethics committee approval and informed consent. Eligible participants will be adults aged 18 years and older without any concomitant anal canal disease. Participants will be allocated into two groups according to the surgical technique performed: (1) Doppler-guided hemorrhoidal artery ligation alone and (2) Doppler-guided hemorrhoidal artery ligation combined with mucopexy.
Postoperative pain will be assessed using a pain scale at the 8th postoperative hour and at the 1st postoperative month. Tenesmus symptoms will be evaluated and recorded at the 2nd postoperative month. The primary outcomes will be postoperative pain scores and the presence of tenesmus. Comparative statistical analyses will be performed between the two groups.
- Conditions
- Postoperative Pain
- Being tested
- HAL + Mucopexy, HAL Alone
- Keywords
- Hemorrhoids, Postoperative Pain
- Medical subject headings
- Pain, Postoperative, Hemorrhoids
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HAL + MucopexyProcedure or surgery
Doppler-guided hemorrhoidal artery ligation will be performed using a Doppler-equipped proctoscope to identify and ligate hemorrhoidal arteries. Following arterial ligation, mucopexy will be performed to lift and secure the prolapsing hemorrhoidal mucosa.
HAL AloneProcedure or surgery
Participants will undergo Doppler-guided hemorrhoidal artery ligation alone for the treatment of hemorrhoidal disease. Hemorrhoidal arteries will be identified using Doppler guidance and ligated without additional mucopexy.
| Study group | Role | What they receive |
|---|---|---|
| HAL + Mucopexy | Experimental | Participants will undergo Doppler-guided hemorrhoidal artery ligation combined with mucopexy for the treatment of hemorrhoidal disease. Hemorrhoidal arteries will be identified using Doppler guidance and ligated, followed by mucopexy to reposition prolapsing hemorrhoidal tissue. Receives: Procedure: HAL + Mucopexy |
| HAL Alone | Active comparator | Participants will undergo Doppler-guided hemorrhoidal artery ligation alone for the treatment of hemorrhoidal disease. Hemorrhoidal arteries will be identified using Doppler guidance and ligated without additional mucopexy. Receives: Procedure: HAL Alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain Score (VAS)
Assessment of pain severity using the Visual Analog Scale (VAS) at the 8th postoperative hour.
Measured: Postoperative Hour 8
Secondary outcomes (1)
Postoperative Pain Score
Assessment of pain severity using the Visual Analog Scale (VAS) at the 1st postoperative month.
Measured: 1 month after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2026
- Study start1 Oct 2026 (estimated)
- Primary completion1 Jun 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ali Genc
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ali Genc, Tokat Gaziosmanpasa University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07710053
- Sponsor's protocol ID
- 25-MOBAEK-080
- Status last verified
- Jul 2026
- First submitted
- 25 Jun 2026
- Last updated
- 17 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Postoperative Pain and Tenesmus Between Doppler-Guided Hemorrhoidal Artery Ligation Alone and Doppler-Guided Hemorrhoidal Artery Ligation Combined With Mucopexy in Patients With Hemorrhoidal Disease
- ClinicalTrials.gov ID
- NCT07710053
- Acronym / sponsor ID
- 25-MOBAEK-080
- Conditions
- Postoperative Pain
- Keywords
- Hemorrhoids, Postoperative Pain
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Ali GencUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 17 Jul 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.
Hemorrhoidal disease is one of the most common anorectal disorders affecting adults worldwide. Doppler-guided hemorrhoidal artery ligation (HAL) is a minimally invasive surgical technique that has gained popularity because of its lower postoperative pain and faster recovery compared with conventional hemorrhoidectomy. In selected patients, HAL may be combined with mucopexy to address prolapsing hemorrhoidal tissue.
The aim of this prospective study is to compare postoperative pain and tenesmus between patients undergoing Doppler-guided hemorrhoidal artery ligation alone and those undergoing Doppler-guided hemorrhoidal artery ligation combined with mucopexy.
Patients diagnosed with hemorrhoidal disease and scheduled for surgical treatment at the General Surgery Department of Tokat Gaziosmanpaşa University Hospital will be enrolled after obtaining ethics committee approval and informed consent. Eligible participants will be adults aged 18 years and older without any concomitant anal canal disease. Participants will be allocated into two groups according to the surgical technique performed: (1) Doppler-guided hemorrhoidal artery ligation alone and (2) Doppler-guided hemorrhoidal artery ligation combined with mucopexy.
Postoperative pain will be assessed using a pain scale at the 8th postoperative hour and at the 1st postoperative month. Tenesmus symptoms will be evaluated and recorded at the 2nd postoperative month. The primary outcomes will be postoperative pain scores and the presence of tenesmus. Comparative statistical analyses will be performed between the two groups.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HAL + Mucopexy | Experimental | Procedure: HAL + MucopexyParticipants will undergo Doppler-guided hemorrhoidal artery ligation combined with mucopexy for the treatment of hemorrhoidal disease. Hemorrhoidal arteries will be identified using Doppler guidance and ligated, followed by mucopexy to reposition prolapsing hemorrhoidal tissue. |
| HAL Alone | Active comparator | Procedure: HAL AloneParticipants will undergo Doppler-guided hemorrhoidal artery ligation alone for the treatment of hemorrhoidal disease. Hemorrhoidal arteries will be identified using Doppler guidance and ligated without additional mucopexy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥18 years
- Diagnosis of hemorrhoidal disease requiring surgical treatment
- Ability to provide written informed consent
- Willingness to participate in the study.
Key exclusion criteria (4 listed)
- Age below 18 years
- Presence of other anal canal diseases (anal fissure, anal fistula, anorectal malignancy, inflammatory bowel disease involving the anorectal region, etc.)
- Previous anorectal surgery that may affect study outcomes
- Inability or unwillingness to provide informed consent.
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 |
|---|---|---|
| HAL + MucopexyDoppler-guided hemorrhoidal artery ligation will be performed using a Doppler-equipped proctoscope to identify and ligate hemorrhoidal arteries. Following arterial ligation, mucopexy will be performed to lift and secure the prolapsing hemorrhoidal mucosa. | Procedure or surgery | HAL + Mucopexy |
| HAL AloneParticipants will undergo Doppler-guided hemorrhoidal artery ligation alone for the treatment of hemorrhoidal disease. Hemorrhoidal arteries will be identified using Doppler guidance and ligated without additional mucopexy. | Procedure or surgery | HAL Alone |
Primary outcome
Postoperative Pain Score (VAS)
Time frame: Postoperative Hour 8
Assessment of pain severity using the Visual Analog Scale (VAS) at the 8th postoperative hour.
1 secondary outcome
Postoperative Pain Score
Time frame: 1 month after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2026.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing HAL + Mucopexy and HAL Alone in people with Postoperative Pain, run by Ali Genc.
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 4 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: opening soon, as of the sponsor's last update on 17 Jul 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ali Genç, Assistant professor (+90-3562129500 ext. +90-5442280060, aligenc0860@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Pain Score (VAS) (time frame: Postoperative Hour 8). 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 17 Jul 2026.