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Reproducibility of a Minimally Invasive Ferguson-type Hemorrhoidectomy for Grade III Hemorrhoids

NCT07695649 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2026-07-10

No results posted yet for this study

Summary

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. Excisional hemorrhoidectomy is the standard procedure. There are two main options: without wound closure (Milligan-Morgan technique) and with wound closure (Ferguson technique). Both options are effective in the long term and cause severe postoperative pain, although comparative studies between Milligan-Morgan and Ferguson hemorrhoidectomy have shown that the Ferguson technique is associated with less postoperative pain and better early wound healing, while maintaining similar long-term efficacy.

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 scarcely been explored in anal surgery. Its potential advantages include reduced tissue injury and improved healing, although it entails a learning curve and may initially prolong operative time.

The IDEAL framework evaluates surgical innovations in five stages: Idea, Development, Exploration, Evaluation, and Long-Term Study. IDEAL phase 2a focuses on the optimization and technical definition of a surgical innovation, emphasizing continuous improvement based on real clinical practice and laying the foundation for broader and more rigorous subsequent studies.

Since no previous studies on the application of MIS in closed Ferguson hemorrhoidectomy have been identified, the investigators propose a phase 2a IDEAL study to assess the reproducibility of this minimally invasive adaptation. The investigators hypothesize that incorporating MIS into the Ferguson technique could further reduce postoperative pain and accelerate recovery, while preserving the well-established effectiveness of closed hemorrhoidectomy in advanced hemorrhoidal disease.

Conditions

  • Minimal Invasive Surgery
  • Hemorrhoidectomy

Interventions

PROCEDURE

Minimal invasive closed hemorrhoidectomy

We propose applying minimally invasive surgery to closed Ferguson excisional hemorrhoidectomy, the most effective technique for treating advanced hemorrhoidal disease. We believe this approach will reduce postoperative pain and improve recovery while maintaining the excellent outcomes of excisional hemorrhoidectomy. Our hypothesis is based on reduced tissue trauma, the increased precision provided by minimally invasive surgery, and secure tissue closure.

Sponsors & Collaborators

  • Hospital Son Llatzer

    lead OTHER

Principal Investigators

  • Ignacio Fernandez-Hurtado, MD · Hospital Son Llatzer

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-15
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07695649 on ClinicalTrials.gov