NCT07520734

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
8mo left

Started Jun 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress20%
Jun 2026Apr 2027

First Submitted

Initial submission to the registry

March 24, 2026

Completed
16 days until next milestone

First Posted

Study publicly available on registry

April 9, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2026

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2027

Last Updated

July 9, 2026

Status Verified

July 1, 2026

Enrollment Period

7 months

First QC Date

March 24, 2026

Last Update Submit

July 8, 2026

Conditions

Keywords

Laser hemorrhoidoplastyHemorrhoidal diseasePatient satisfactionVisual Analog Scale

Outcome Measures

Primary Outcomes (1)

  • 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.

    At 6 hours, 24 hours, and 1 week after surgery

Secondary Outcomes (5)

  • Duration of postoperative analgesic use

    From the day of surgery through 30 days after surgery

  • Length of hospital stay

    From the day of surgery to hospital discharge, up to 7 days

  • Incidence of predefined early postoperative complications

    Within 30 days after surgery

  • Time to return to daily activities

    Up to 30 days after surgery

  • Patient satisfaction

    Up to 3 months after surgery

Study Arms (1)

Patients undergoing laser hemorrhoidoplasty

Adults with symptomatic internal hemorrhoidal disease undergoing laser hemorrhoidoplasty.

Procedure: Laser Hemorrhoidoplasty

Interventions

Laser-based minimally invasive treatment of internal hemorrhoidal disease performed as part of routine clinical care.

Patients undergoing laser hemorrhoidoplasty

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • 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'

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sanliurfa Education and Research Hospital

Sanliurfa, Şanlıurfa, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Patient Satisfaction

Condition Hierarchy (Ancestors)

Treatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Vedat Kaplan

    Sanliurfa Education and Research Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
General Surgery Specialist

Study Record Dates

First Submitted

March 24, 2026

First Posted

April 9, 2026

Study Start

June 1, 2026

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

April 1, 2027

Last Updated

July 9, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

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.

Locations