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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Hemorrhoidectomy; Minimal Invasive Surgery
• Intervention / Treatment: Procedure: Minimal invasive closed hemorrhoidectomy

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: Ignacio Fernandez_Hurtado, MD; Phone Number: 2134 +34871202000; Email: ifernandez@hsll.es

Study Locations

• Spain
  • Palma de Mallorca, Spain, 07190
    • Recruiting
    • Hospital Son Llatzer
    • Contact: Ignacio Fernandez-Hurtado, MD; Phone Number: 2134 +34 871202000; Email: ifernandez@hsll.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients attending the Surgery Department of our Hospital

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Grade III-IV Hemorrhoids; Patients with symptomatic grade III-IV hemorrhoids who consent to surgical interv

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Technical Reproducibility of Surgery	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.	30 postoperative days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events in treated patients	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	30 postoperative days
Postoperative pain	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.	The first 14 postoperative days
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 postoperative 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 postoperative
Total number of postoperative analgesics	The total number of analgesic doses taken by the patient during the first 14 postoperative days will be recorded as a numeric variable	14 postoperative days
Hemorrhoidal Clinical Fail Rate	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%.	One postoperative year

Collaborators and Investigators

• Sponsor: Hospital Son Llatzer
• Investigators: Principal Investigator: Ignacio Fernandez-Hurtado, MD, Hospital Son Llatzer

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: July 5, 2026
• First Submitted That Met QC Criteria: July 5, 2026
• First Posted (Actual): July 10, 2026

Study Record Updates

• Last Update Posted (Actual): July 10, 2026
• Last Update Submitted That Met QC Criteria: July 5, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Minimal Invasive Surgery; hemorrhoids grade III-IV; IDEAL stage 1; Closed hemorrhoidectomy
• Other Study ID Numbers: HEM IDEAL 2A_FERGUSON

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No