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OpenTrials
Completed

NCT Number: NCT06420986

Open Hemorrohoidectomy Vs Transanal Hemorrhoidal Desarterialization in Hemorrhoids Grade III: The Effect on Symptoms

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.

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Key information

Conditions

Hemorrhoids Third Degree

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Son Llatzer

Palma de Mallorca, Balearic Islands, 07198, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Open Hemorrhoidectomy

Procedure

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

Transanal Hemorrhoidal Dearterialization

Procedure

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

Primary outcomes

  1. Hemorrhoidal Disease Symptom Score

    Time frame: one year

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

  2. Short Health Scale in Hemorrhoidal Disease

    Time frame: one year

    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

Secondary outcomes

  1. Postoperative Pain

    Time frame: 1 week after surgical procedure

    pain measured in visual analogic scale (VAS) Scale: 0 to 10. Higher scores mean a worse outcome

  2. Fecal Incontinence

    Time frame: one year after surgical procedure

    measured in Wexner scale. Score 0 to 20. Higher scores mean a worse outcome

Sponsors and collaborators

Lead sponsor

Hospital Son Llatzer

Other

Collaborators

  • Fundació d'investigació Sanitària de les Illes Balears

Registry information

Official study title

Open Hemorrohoidectomy Versus Transanal Hemorrhoidal Desarterialization in Hemorrhoids Grade III: The Effect on Symptons: An Open-label Randomized Controlled Trial

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
May 20, 2024
Registry last updated
Apr 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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