- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07520734
Clinical Outcomes After Laser Hemorrhoidoplasty (LHP)
April 2, 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
Not yet recruiting
Conditions
Intervention / Treatment
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
Observational
Enrollment (Estimated)
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
- Name: Vedat Kaplan, MD
- Phone Number: +905459045165
- Email: vedat_kaplan_@hotmail.com
Study Locations
-
-
Şanlıurfa
-
Sanliurfa, Şanlıurfa, Turkey (Türkiye)
- Sanliurfa Education and Research Hospital
-
Contact:
- Vedat Kaplan, MD
- Phone Number: +905459045165
- Email: vedat_kaplan_@hotmail.com
-
-
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
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 |
Intervention / Treatment |
|---|---|
|
Patients undergoing laser hemorrhoidoplasty
Adults with symptomatic internal hemorrhoidal disease undergoing 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
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
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.
Investigators
- 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 (Estimated)
April 1, 2026
Primary Completion (Estimated)
January 1, 2027
Study Completion (Estimated)
April 1, 2027
Study Registration Dates
First Submitted
March 24, 2026
First Submitted That Met QC Criteria
April 2, 2026
First Posted (Actual)
April 9, 2026
Study Record Updates
Last Update Posted (Actual)
April 9, 2026
Last Update Submitted That Met QC Criteria
April 2, 2026
Last Verified
April 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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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