MINIMALLY INVASIVE SURGERY FOR GRADE III HEMORRHOIDS

NCT07534761 | Not Yet Recruiting

• 1 other identifier: HEM CLOSE IDEAL 2A
• 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. 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.

Conditions

Hemorrhoidectomy; Minimally Invasive Surgical Technique

Keywords

hemorrhoids grade III-IV; Hemorrhoidectomy; IDEAL stage 2A; minimally Invasive Surgical Technique

Outcome Measures

Primary Outcomes (1)

• Technical Reproducibility of Surgery

  ince 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

• Postoperative pain

  The first 14 postoperative days

• Hemorrhoidal disease symptom score

  one postoperative year

• Short Health Scale in hemorrhoidal disease

  One year postoperative

• Total number of postoperative analgesics

  14 postoperative days

Study Arms (1)

Grade III / IV hemorrhoids

Patients with symptomatic grade III/IV hemorrhoids who consent to surgical intervention

Procedure: Minimally Invasive hemorrhoidectomy

Interventions

Minimally Invasive hemorrhoidectomy PROCEDURE

We propose applying minimally invasive surgery in closed excisional hemorrhoidectomy (CEH) , 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 CEH. Our hypothesis is based on the reduced tissue trauma and increased precision provided by minimally invasive surgery.

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 CEH 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, Balearic Islands, 07190, Spain

Location

Central Study Contacts

Ignacio Fernandez-Hurtado, Colorectal Surgeon

CONTACT

+34 871202000; ifernandez@hsll.es

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: April 10, 2026
• First Posted: April 16, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: April 16, 2026

Record last verified: 2026-04

Locations

ES (1)