Hemorrhoidal DiseaseLHPNCT07520734
Clinical Outcomes After Laser Hemorrhoidoplasty
An observational study of Hemorrhoidal Disease and Internal Hemorrhoids, run by Sanliurfa Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
This single-center prospective observational study aims to evaluate clinical outcomes, postoperative pain scores, complications, and patient satisfaction in adults undergoing laser hemorrhoidoplasty for symptomatic internal hemorrhoidal disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemorrhoidal Disease, Internal Hemorrhoids
- What is being tested?
- Laser Hemorrhoidoplasty
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2026to 1 Apr 2027
- Phase
- Observational
- 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
Study population: Adult patients with symptomatic internal hemorrhoidal disease who are scheduled to undergo laser hemorrhoidoplasty at the General Surgery Clinic of Sanliurfa Education and Research Hospital.
Who may be able to join
- Age 18 years or older
- Symptomatic internal hemorrhoidal disease
- Scheduled to undergo laser hemorrhoidoplasty
- Willingness to participate and provision of informed consent
Who cannot join
- Grade IV hemorrhoidal disease
- Acute thrombosed hemorrhoids
- Additional anorectal pathology such as anal fissure, fistula, or perianal abscess
- History of inflammatory bowel disease or colorectal malignancy
- Previous major anal surgery'
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Sanliurfa Education and Research Hospital
Sanliurfa, Şanlıurfa
Vedat Kaplan, MD, +905459045165, vedat_kaplan_@hotmail.com
About this study
Official title: Clinical Outcomes, Pain Scores, and Patient Satisfaction in Patients Undergoing Laser Hemorrhoidoplasty: A Prospective Observational Study
This single-center prospective observational study aims to evaluate clinical outcomes, postoperative pain scores, complications, and patient satisfaction in adults undergoing laser hemorrhoidoplasty for symptomatic internal hemorrhoidal disease. Additional objectives are to assess the relationship between hemorrhoid stage, dominant presenting symptoms, operative technical details, and postoperative outcomes. No study-specific intervention beyond routine clinical care and follow-up will be performed.
Read the detailed description
Hemorrhoidal disease is a common benign anorectal condition that can significantly impair quality of life. Conventional excisional techniques may be associated with postoperative pain, bleeding, prolonged recovery, and lower patient satisfaction. Laser hemorrhoidoplasty is a minimally invasive technique based on coagulation and shrinkage of hemorrhoidal tissue without excision. This prospective observational study will be conducted at the General Surgery Clinic of Sanliurfa Education and Research Hospital. Adult patients with symptomatic internal hemorrhoidal disease who are scheduled to undergo laser hemorrhoidoplasty will be enrolled. Preoperative symptoms, hemorrhoid stage, and physical examination findings will be recorded. Intraoperative data will include laser wavelength, total delivered energy, number of hemorrhoidal packages treated, and any additional surgical procedures. Postoperative pain will be assessed at predefined time points using the Visual Analog Scale. Analgesic requirement and duration, length of hospital stay, time to return to daily activities, early complications within 30 days, late complications, symptom status, and recurrence at 6 months will be documented. The study is designed to clarify the clinical role of laser hemorrhoidoplasty and help define appropriate patient selection criteria.
- Conditions
- Hemorrhoidal Disease, Internal Hemorrhoids
- Being tested
- Laser Hemorrhoidoplasty
- Keywords
- Laser hemorrhoidoplasty, Hemorrhoidal disease, Patient satisfaction, Visual Analog Scale
- Medical subject headings
- Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laser HemorrhoidoplastyProcedure or surgery
Laser-based minimally invasive treatment of internal hemorrhoidal disease performed as part of routine clinical care.
| Study group | Role | What they receive |
|---|---|---|
| Patients undergoing laser hemorrhoidoplasty | Adults with symptomatic internal hemorrhoidal disease undergoing laser hemorrhoidoplasty. Receives: Procedure: Laser Hemorrhoidoplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain score
Postoperative pain assessed using a 0 to 10 Visual Analog Scale (VAS), where 0 indicates no pain and 10 indicates the worst imaginable pain; higher scores indicate worse pain.
Measured: At 6 hours, 24 hours, and 1 week after surgery
Secondary outcomes (5)
Duration of postoperative analgesic use
Duration of postoperative analgesic use, measured in days.
Measured: From the day of surgery through 30 days after surgery
Length of hospital stay
Postoperative hospital stay, measured in days from the date of surgery to the date of discharge.
Measured: From the day of surgery to hospital discharge, up to 7 days
Incidence of predefined early postoperative complications
Number and proportion of patients who develop any predefined early postoperative complication within 30 days after laser hemorrhoidoplasty. Predefined complications include postoperative bleeding, urinary retention, anal thrombosis, infection, severe pain, and anal stenosis. Patients without any of these events will be classified as having no complication.
Measured: Within 30 days after surgery
Time to return to daily activities
Time required to return to usual daily activities, measured in days.
Measured: Up to 30 days after surgery
Patient satisfaction
Patient-reported satisfaction after laser hemorrhoidoplasty.
Measured: Up to 3 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2026
- Study start1 Jun 2026
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemorrhoidal DiseaseStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sanliurfa Education and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Vedat Kaplan, Sanliurfa Education and Research Hospital
- Investigators
- Vedat Kaplan, Principal investigator, Sanliurfa Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07520734
- Sponsor's protocol ID
- SEAH-LHP
- Acronym
- LHP
- Status last verified
- Jul 2026
- First submitted
- 24 Mar 2026
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because this is a single-center study involving sensitive patient-level clinical data, and there is no pre-specified institutional mechanism for external data sharing. Only aggregated, de-identified study results will be reported.
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcomes, Pain Scores, and Patient Satisfaction in Patients Undergoing Laser Hemorrhoidoplasty: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT07520734
- Acronym / sponsor ID
- LHP / SEAH-LHP
- Conditions
- Hemorrhoidal Disease, Internal Hemorrhoids
- Keywords
- Laser hemorrhoidoplasty, Hemorrhoidal disease, Patient satisfaction, Visual Analog Scale
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Sanliurfa Education and Research HospitalOther government
- Study start
- 1 Jun 2026 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 9 Apr 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.
This single-center prospective observational study aims to evaluate clinical outcomes, postoperative pain scores, complications, and patient satisfaction in adults undergoing laser hemorrhoidoplasty for symptomatic internal hemorrhoidal disease. Additional objectives are to assess the relationship between hemorrhoid stage, dominant presenting symptoms, operative technical details, and postoperative outcomes. No study-specific intervention beyond routine clinical care and follow-up will be performed.
Detailed description
Hemorrhoidal disease is a common benign anorectal condition that can significantly impair quality of life. Conventional excisional techniques may be associated with postoperative pain, bleeding, prolonged recovery, and lower patient satisfaction. Laser hemorrhoidoplasty is a minimally invasive technique based on coagulation and shrinkage of hemorrhoidal tissue without excision. This prospective observational study will be conducted at the General Surgery Clinic of Sanliurfa Education and Research Hospital. Adult patients with symptomatic internal hemorrhoidal disease who are scheduled to undergo laser hemorrhoidoplasty will be enrolled. Preoperative symptoms, hemorrhoid stage, and physical examination findings will be recorded. Intraoperative data will include laser wavelength, total delivered energy, number of hemorrhoidal packages treated, and any additional surgical procedures. Postoperative pain will be assessed at predefined time points using the Visual Analog Scale. Analgesic requirement and duration, length of hospital stay, time to return to daily activities, early complications within 30 days, late complications, symptom status, and recurrence at 6 months will be documented. The study is designed to clarify the clinical role of laser hemorrhoidoplasty and help define appropriate patient selection criteria.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing laser hemorrhoidoplasty | – | Procedure: Laser HemorrhoidoplastyAdults with symptomatic internal hemorrhoidal disease undergoing laser hemorrhoidoplasty. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with symptomatic internal hemorrhoidal disease who are scheduled to undergo laser hemorrhoidoplasty at the General Surgery Clinic of Sanliurfa Education and Research Hospital.
Key inclusion criteria (4 listed)
- Age 18 years or older
- Symptomatic internal hemorrhoidal disease
- Scheduled to undergo laser hemorrhoidoplasty
- Willingness to participate and provision of informed consent
Key exclusion criteria (5 listed)
- Grade IV hemorrhoidal disease
- Acute thrombosed hemorrhoids
- Additional anorectal pathology such as anal fissure, fistula, or perianal abscess
- History of inflammatory bowel disease or colorectal malignancy
- Previous major anal 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 |
|---|---|---|
| Laser HemorrhoidoplastyLaser-based minimally invasive treatment of internal hemorrhoidal disease performed as part of routine clinical care. | Procedure or surgery | Patients undergoing laser hemorrhoidoplasty |
Primary outcome
Postoperative pain score
Time frame: At 6 hours, 24 hours, and 1 week after surgery
Postoperative pain assessed using a 0 to 10 Visual Analog Scale (VAS), where 0 indicates no pain and 10 indicates the worst imaginable pain; higher scores indicate worse pain.
5 secondary outcomes
Duration of postoperative analgesic use
Time frame: From the day of surgery through 30 days after surgery
Length of hospital stay
Time frame: From the day of surgery to hospital discharge, up to 7 days
Incidence of predefined early postoperative complications
Time frame: Within 30 days after surgery
Time to return to daily activities
Time frame: Up to 30 days after surgery
Patient satisfaction
Time frame: Up to 3 months 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 9 Jul 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because this is a single-center study involving sensitive patient-level clinical data, and there is no pre-specified institutional mechanism for external data sharing. Only aggregated, de-identified study results will be reported.
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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.
Vedat Kaplan principal investigator
Sanliurfa Education and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hemorrhoidal Disease and Internal Hemorrhoids, run by Sanliurfa Education and Research Hospital at 1 site in Turkey (Türkiye).
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 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: looking for participants now, as of the sponsor's last update on 9 Jul 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 Turkey (Türkiye). 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?
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 Vedat Kaplan, MD (+905459045165, vedat_kaplan_@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative pain score (time frame: At 6 hours, 24 hours, and 1 week after surgery). 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 9 Jul 2026.