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NCT Number: NCT07695649

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

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.

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Key information

Conditions

Minimal Invasive Surgery Hemorrhoidectomy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Son Llatzer

Palma de Mallorca, 07190, Spain

Location status: Recruiting

Location contact

Ignacio Fernandez-Hurtado, MD

CONTACT

[email protected]

+34 871202000 ext. 2134

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age over 18 years
  • Grade III-IV hemorrhoids
  • Indication for excisional hemorrhoidectomy 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

Treatment and study plan

Minimal invasive closed hemorrhoidectomy

Procedure

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.

Primary outcomes

  1. Technical Reproducibility of Surgery

    Time frame: 30 postoperative days

    Since no studies using this approach were found in the literature, the investigators propose a study to assess the reproducibility of implementing this technique following the guidelines of the IDEAL framework. In this study, the investigators propose Stage 2A. The measurement tool will be the systematic documentation of technical modifications.

Secondary outcomes

  1. Adverse events in treated patients

    Time frame: 30 postoperative days

    Collect the adverse effects that occur during the operative period and within the first 30 postoperative days. Filter those attributable to the use of the minimally invasive approach. Analyze the causes and the technical steps that should be performed or omitted to avoid them. As measurement tools, the Clavien-Dindo scale and the Comprehensive Complication Index (CCI) will be used. The CCI is an index that uses the Clavien-Dindo scale and is calculated with a mathematical formula available at www.assessurgery.com

  2. Total number of postoperative analgesics

    Time frame: 14 postoperative days

    The total number of analgesic doses taken by the patient during the first 14 postoperative days will be recorded as a numeric variable

  3. Postoperative pain

    Time frame: The first 14 postoperative days

    Postoperative pain will be evaluated using the Visual Analogue Scale (VAS), a validated tool ranging from 0 (no pain) to 10 (worst imaginable pain). Patients will self-assess their baseline pain and pain following defecation at predefined intervals: postoperative days 4, 7, and 14.

  4. Short Health Scale in hemorrhoidal disease

    Time frame: One year postoperative

    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.

  5. Hemorrhoidal disease symptom score

    Time frame: one postoperative year

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

  6. Hemorrhoidal Clinical Fail Rate

    Time frame: One postoperative year

    It is a pragmatic composite endpoint. It is determined by assessing changes in haemorrhoidal symptoms according to the HDSS and haemorrhoidal disease-related quality of life according to the SHS-HD, comparing baseline and 1-year values. The change in haemorrhoidal symptoms is calculated using the following formula: (baseline HDSS-postoperative HDSS)/baseline HDSS×100. The change in haemorrhoidal disease-related quality of life is calculated using the following formula: (baseline SHS-HD-postoperative SHS-HD)/baseline SHS-HD×100. CFR is positive when both criteria show a reduction of at least 50%.

Study contacts

Contact information is provided by the study sponsor or research team.

Ignacio Fernandez_Hurtado, MD

CONTACT

[email protected]

+34871202000 ext. 2134

Sponsors and collaborators

Lead sponsor

Hospital Son Llatzer

Other

Registry information

Official study title

Prospective Observational Study to Assess the Reproducibility of Ferguson's Minimally Invasive Hemorrhoidectomy in the Treatment of Grade III Hemorrhoids: Phase 2a of the IDEAL Framework

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jul 10, 2026
Registry last updated
Jul 10, 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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