NCT07333040

Brief Summary

This prospective, multicenter study compares the efficacy and functional outcomes of three surgical treatments for symptomatic Goligher Grade III internal hemorrhoids: Laser Hemorrhoidoplasty (LHP), Hemorrhoid Energy Therapy (HET), and conventional closed hemorrhoidectomy (Ferguson technique). Due to strong patient preferences in hemorrhoidal surgery, this study utilizes a pragmatic, preference-tolerant design. Eligible patients will undergo standardized counseling and select their preferred treatment arm. The study aims to evaluate whether minimally invasive energy-based therapies offer superior postoperative pain relief and faster functional recovery compared to conventional hemorrhoidectomy

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
22mo left

Started Mar 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress9%
Mar 2026Mar 2028

First Submitted

Initial submission to the registry

January 1, 2026

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 12, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2026

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2027

Expected
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2028

Last Updated

January 12, 2026

Status Verified

January 1, 2026

Enrollment Period

1.2 years

First QC Date

January 1, 2026

Last Update Submit

January 1, 2026

Conditions

Hemorrhoids Third DegreeInternal HemorrhoidsMixed Hemorrhoids

Keywords

Laser HemorrhoidoplastyHemorrhoid Energy TherapyPostoperative PainMinimally Invasive SurgeryHemorrhoidectomy

Outcome Measures

Primary Outcomes (2)

  • Time to Functional Recovery

    Days to return to work or normal daily activities.

    Up to 1 month post-operation

  • Post-operative Pain Trajectory (Area Under the Curve)

    Assessed using Numeric Rating Scale (0-10). Calculated as Area Under the Curve (AUC).

    Post-operative Day 1 to Day 14

Secondary Outcomes (1)

  • Recurrence Rate

    12 months post-operation

Study Arms (3)

Laser Hemorrhoidoplasty (LHP)

EXPERIMENTAL

1470nm or 980nm diode laser ablation

Procedure: Laser Hemorrhoidoplasty (LHP)

Hemorrhoid Energy Therapy (HET)

EXPERIMENTAL

Bipolar radiofrequency coagulation using HET™ system

Procedure: Hemorrhoid Energy Therapy (HET)

Conventional Hemorrhoidectomy

ACTIVE COMPARATOR

Standard closed excisional hemorrhoidectomy

Procedure: Ferguson Hemorrhoidectomy

Interventions

Laser Hemorrhoidoplasty (LHP)PROCEDURE

1470nm or 980nm diode laser ablation

Laser Hemorrhoidoplasty (LHP)
Hemorrhoid Energy Therapy (HET)PROCEDURE

Bipolar radiofrequency coagulation using HET™ system

Hemorrhoid Energy Therapy (HET)
Ferguson HemorrhoidectomyPROCEDURE

Standard closed excisional hemorrhoidectomy

Conventional Hemorrhoidectomy

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosed with Goligher Grade III internal hemorrhoids.
  • Symptomatic with HDSS score \>= 5.
  • Age 18-75 years.
  • Fit for general anesthesia or sedation.
  • Able to provide informed consent.
  • Agree to pre-operative photo documentation.

You may not qualify if:

  • Other anorectal diseases (fistula, abscess, IBD, malignancy).
  • Prior anorectal surgery within 6 months.
  • Pregnancy or lactation.
  • Contraindications to anesthesia.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chang Gung Memorial Hospital, Linkou Branch

Taoyuan District, 333, Taiwan

Location

Related Publications (4)

  • van Oostendorp JY, Dekker L, van Dieren S, Veldkamp R, Bemelman WA, Han-Geurts IJM; HollAND Study Group. Comparison of Rubber Band Ligation and Hemorrhoidectomy in Patients With Symptomatic Hemorrhoids Grade III: A Multicenter, Open-Label, Randomized Controlled Noninferiority Trial. Dis Colon Rectum. 2025 May 1;68(5):572-583. doi: 10.1097/DCR.0000000000003679. Epub 2025 Feb 14.

    PMID: 39952268BACKGROUND

  • Gambardella C, Brusciano L, Brillantino A, Parisi S, Lucido FS, Del Genio G, Tolone S, Allaria A, Di Saverio S, Pizza F, Sturiale A, Docimo L. Mid-term efficacy and postoperative wound management of laser hemorrhoidoplasty (LHP) vs conventional excisional hemorrhoidectomy in grade III hemorrhoidal disease: the twisting trend. Langenbecks Arch Surg. 2023 Apr 5;408(1):140. doi: 10.1007/s00423-023-02879-4.

    PMID: 37020091BACKGROUND

  • Hawkins AT, Davis BR, Bhama AR, Fang SH, Dawes AJ, Feingold DL, Lightner AL, Paquette IM; Clinical Practice Guidelines Committee of the American Society of Colon and Rectal Surgeons. The American Society of Colon and Rectal Surgeons Clinical Practice Guidelines for the Management of Hemorrhoids. Dis Colon Rectum. 2024 May 1;67(5):614-623. doi: 10.1097/DCR.0000000000003276. Epub 2024 Jan 31. No abstract available.

    PMID: 38294832BACKGROUND

  • Giuliani A, Romano L, Necozione S, Cofini V, Di Donato G, Schietroma M, Carlei F; EMODART3 Study Group. Excisional Hemorrhoidectomy Versus Dearterialization With Mucopexy for the Treatment of Grade III Hemorrhoidal Disease: The EMODART3 Multicenter Study. Dis Colon Rectum. 2023 Dec 1;66(12):e1254-e1263. doi: 10.1097/DCR.0000000000002885. Epub 2023 Aug 24.

    PMID: 37616177BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Central Study Contacts

I-Li Lai, MD

CONTACT

+886911978067ryane92a5@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Due to the distinct physical nature of the surgical interventions (conventional excision vs. energy-based ablation), blinding of participants and care providers is not feasible. To minimize detection bias, the determination of recurrence and the need for re-intervention (secondary endpoint) will be adjudicated by an independent committee blinded to the treatment allocation. Additionally, data regarding patient-reported outcomes (pain, HDSS) will be collected by research staff who are not involved in the surgical procedures.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Due to the distinct physical nature of the surgical interventions (conventional excision vs. energy-based ablation), blinding of participants and care providers is not feasible. To minimize detection bias, the determination of recurrence and the need for re-intervention (secondary endpoint) will be adjudicated by an independent committee blinded to the treatment allocation. Additionally, data regarding patient-reported outcomes (pain, HDSS) will be collected by research staff who are not involved in the surgical procedures.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 1, 2026

First Posted

January 12, 2026

Study Start

March 1, 2026

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

March 1, 2028

Last Updated

January 12, 2026

Record last verified: 2026-01

Locations

TW(1)