Clinical Outcomes After Laser Hemorrhoidoplasty (LHP)

July 8, 2026 updated by: Vedat Kaplan, Sanliurfa Education and Research Hospital

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Turkey (Türkiye)
    • Şanlıurfa
      • Sanliurfa, Şanlıurfa, Turkey (Türkiye)
        • Recruiting
        • Sanliurfa Education and Research Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  • Age 18 years or older
  • Symptomatic internal hemorrhoidal disease
  • Scheduled to undergo laser hemorrhoidoplasty
  • Willingness to participate and provision of informed consent

Exclusion Criteria:

  • 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'

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Patients undergoing laser hemorrhoidoplasty
Adults with symptomatic internal hemorrhoidal disease undergoing laser hemorrhoidoplasty.
Procedure: Laser Hemorrhoidoplasty
Laser-based minimally invasive treatment of internal hemorrhoidal disease performed as part of routine clinical care.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
At 6 hours, 24 hours, and 1 week after surgery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Duration of postoperative analgesic use
Time Frame: From the day of surgery through 30 days after surgery
Duration of postoperative analgesic use, measured in days.
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
Postoperative hospital stay, measured in days from the date of surgery to the date of discharge.
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
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.
Within 30 days after surgery
Time to return to daily activities
Time Frame: Up to 30 days after surgery
Time required to return to usual daily activities, measured in days.
Up to 30 days after surgery
Patient satisfaction
Time Frame: Up to 3 months after surgery
Patient-reported satisfaction after laser hemorrhoidoplasty.
Up to 3 months after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sanliurfa Education and Research Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Vedat Kaplan, Sanliurfa Education and Research Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 24, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 2, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 9, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 9, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 8, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SEAH-LHP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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