NCT06420986

Brief Summary

The goal of this clinical trial is to learn if open hemorroidectomy diminishes symptoms compared to transanal hemorrhoidal desarterialization (THD) in patients presenting with hemorrhoids grade III. The main question it aims to answer is: \- Do patients undergoing open hemorroidectomy present with lesser symptoms 1 year after surgery, compared to those undergoing a THD? Researchers will compare open hemorroidectomy to THD in terms of symptom response one year after the procedure. Participants will:

  • Undergo surgical treatment of hemorroids performed by one of the two techniques: open hemorroidectomy versus THD.
  • Fill in symptom forms before and one year after the surgical procedure.
  • Attend control visits one week, one month, three months and one year after the surgical procedure.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

August 12, 2021

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 17, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 17, 2024

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

May 15, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 20, 2024

Completed
1.9 years until next milestone

Results Posted

Study results publicly available

March 31, 2026

Completed
Last Updated

April 17, 2026

Status Verified

April 1, 2026

Enrollment Period

2.7 years

First QC Date

May 15, 2024

Results QC Date

February 18, 2026

Last Update Submit

April 4, 2026

Conditions

Hemorrhoids Third Degree

Keywords

hemorrhoids third degreebotulinum ToxinHemorrhoidectomyTransanal Hemorrhoidal Dearterializationhemorrhoidal Disease Symptom Score

Outcome Measures

Primary Outcomes (2)

  • Hemorrhoidal Disease Symptom Score

    A score that defines the frecuency of pain, pruritus, bleeding, soiling and prolapse. Score 0 to 20. Higher scores mean a worse outcome

    one year

  • Short Health Scale in Hemorrhoidal Disease

    a subjective scale which defines symptom intensity, the patient's worrying and the role in impairment of daily activity. Score 4 to 28. Higher scores mean a worse outcome

    one year

Secondary Outcomes (2)

  • Postoperative Pain

    1 week after surgical procedure

  • Fecal Incontinence

    one year after surgical procedure

Study Arms (2)

Hemorrhoidectomy

EXPERIMENTAL
Procedure: Open Hemorrhoidectomy

Transanal Hemorrhoidal Dearterialization

EXPERIMENTAL
Procedure: Transanal Hemorrhoidal Dearterialization

Interventions

Open HemorrhoidectomyPROCEDURE

Surgical treatment of Hemorrhoids. Removal of hemorrohids leaving the wounds open. Surgical technique described by Milligan Morgan

Hemorrhoidectomy
Transanal Hemorrhoidal DearterializationPROCEDURE

Surgical treatment of Hemorrhoids. This operation involves no excision. The hemorrhoidal arteries are ligated and the hemorrhoial prolapse is treated by a suture mucopexi. Described by Rato

Transanal Hemorrhoidal Dearterialization

Eligibility Criteria

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

You may qualify if:

  • Age older than 18.
  • Hemorroids grade III.
  • Surgical indication for hemorroid treatment.
  • Signed informed consent.

You may not qualify if:

  • Acute hemorroidal disease.
  • Previous hemorroidal surgery.
  • Concomitant anal fissure.
  • Concomitant perianal fistulae.
  • Concomitant rectal prolapse.
  • Inflamatory bowel disease.
  • Anal or colorrectal cancer.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Son Llatzer

Palma de Mallorca, Balearic Islands, 07198, Spain

Location

Related Publications (1)

  • Fernandez-Hurtado I, Pages-Valle N, Sarubbo MF, Claramonte-Bellmunt O, Baena-Bradaschia S, Cifuentes-Rodenas JA, Serra-Aracil X. Open excisional haemorrhoidectomy versus transanal haemorrhoidal dearterialization for grade III haemorrhoids: open-label randomized clinical trial. Br J Surg. 2025 Dec 24;113(1):znaf282. doi: 10.1093/bjs/znaf282.

    PMID: 41553737RESULT

Results Point of Contact

Title
Ignacio Fernandez
Organization
Hospital Son Llatzer
ifernandez@hsll.es
+3487120000

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Specialist in General Surgery. Specialist in Digestive Surgery

Study Record Dates

First Submitted

May 15, 2024

First Posted

May 20, 2024

Study Start

August 12, 2021

Primary Completion

April 17, 2024

Study Completion

April 17, 2024

Last Updated

April 17, 2026

Results First Posted

March 31, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)