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Not yet recruiting NCT07534761

Minimaly Ivnasive Surgery for Grade III Hemorrhoids

— Observational Hemorrhoidectomy Minimally Invasive Surgical Technique

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Minimally Invasive hemorrhoidectomy.
Who it may be relevant to
Registry conditions: Hemorrhoidectomy, Minimally Invasive Surgical Technique. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Spain
Next step
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Official title

Prospective Observational Study to Assess the Reproducibility of Minimally Invasive Surgery in Closed Excisional Hemorrhoidectomy: Phase 2A of theI DEAL Framework

Overview

Hemorrhoids are vascular-elastic structures of the anal canal that contribute to continence. Their enlargement and descent lead to symptoms such as rectal bleeding and the sensation of anal swelling, known as hemorrhoidal syndrome. In advanced cases (Goligher Grade III-IV), surgery is the only effective treatment. Closed excisional hemorrhoidectomy (CEH), based on the Ferguson technique, is one of the standard procedures. Although effective in the long term, it causes severe postoperative pain. Minimally invasive surgery (MIS) employs enhanced visualization devices to improve surgical precision and reduce tissue damage. While widely used in specialties with small surgical fields, it has not yet been explored in anal surgery. Its advantages include reduced tissue injury and improved healing, although it presents a learning curve and an initially longer surgical time. The IDEAL framework evaluates surgical innovations in five stages: Idea, Development, Exploration, Evaluation, and Long-Term Study. The IDEAL phase 2a is aimed at the optimization and technical definition of surgical innovation with a focus on continuous improvement based on real clinical practice, laying the foundation for broader and more rigorous subsequent studies. Since no previous studies on the application of MIS in CEH have been found, the investigators propose a study within Stage 2A of the IDEAL model to assess the reproducibility of this technique. The investigators believe its incorporation into closed excisional hemorrhoidectomy could result in less postoperative pain and faster patient recovery.

Interventions

  • Procedure Minimally Invasive hemorrhoidectomy
    The investigators propose applying minimally invasive surgery in closed excisional hemorrhoidectomy (CEH) , the most effective technique for treating advanced hemorrhoidal disease. The investigators believe this approach will reduce postoperative pain and improve recovery while maintaining the excellent outcomes of CEH. The investigator's hypothesis is based on the reduced tissue trauma and increased precision provided by minimally invasive surgery.

Primary outcome measures

  • Technical Reproducibility of Surgery [Time frame: 30 postoperative days]
Secondary outcome measures (6)
  • Adverse events in treated patients [Time frame: 30 postoperative days]
  • Postoperative pain [Time frame: The first 14 postoperative days]
  • Hemorrhoidal disease symptom score [Time frame: one postoperative year]
  • Short Health Scale in hemorrhoidal disease [Time frame: One year postoperative]
  • Total number of postoperative analgesics [Time frame: 14 postoperative days]
  • Clinical Failure Rate [Time frame: one year postoperative]

Eligibility criteria

Inclusion criteria

  • Age over 18 years
  • Grade III/IV hemorrhoids
  • Indication for CEH surgery
  • Signed written informed consent

Exclusion criteria

  • Acute hemorrhoidal disease (thrombosis)
  • Previous hemorrhoid surgery
  • Coexistence of anal fissure
  • Coexistence of perianal fistula
  • Coexistence of rectal or anal prolapse
  • Active inflammatory bowel disease
  • Active anal or colorectal cancer
  • Language barrier or difficulty in oral and/or written comprehension

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

Spain · 1 center
  • Hospital Son Llatzer — Palma

Identifiers

NCT: NCT07534761 · HEM CLOSE IDEAL 2A

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗