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

NCT07695649 | Recruiting

• 1 other identifier: HEM IDEAL 2A_FERGUSON
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

hemorrhoids grade III-IV; Minimal Invasive Surgery; IDEAL stage 1; Closed hemorrhoidectomy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Adverse events in treated patients

  30 postoperative days

• Total number of postoperative analgesics

  14 postoperative days

• Postoperative pain

  The first 14 postoperative days

• Short Health Scale in hemorrhoidal disease

  One year postoperative

• Hemorrhoidal disease symptom score

  one postoperative year

Study Arms (1)

Grade III-IV Hemorrhoids

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

Procedure: Minimal invasive closed hemorrhoidectomy

Interventions

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.

Grade III-IV Hemorrhoids

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients attending the Surgery Department of our Hospital

You may qualify if:

• Age over 18 years
• Grade III-IV hemorrhoids
• Indication for excisional hemorrhoidectomy surgery
• Signed written informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital Son Llatzer: lead

Study Sites (1)

Hospital Son Llatzer

Palma de Mallorca, 07190, Spain

RECRUITING

Study Officials

• Ignacio Fernandez-Hurtado, MD

  Hospital Son Llatzer

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ignacio Fernandez_Hurtado, MD

CONTACT

+34871202000; ifernandez@hsll.es

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: July 5, 2026
• First Posted: July 10, 2026
• Study Start: June 15, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: July 10, 2026

Record last verified: 2026-07

Locations

ES (1)