Minimaly Ivnasive Surgery for Grade III Hemorrhoids

Prospective Observational Study to Assess the Reproducibility of Minimally Invasive Surgery in Closed Excisional Hemorrhoidectomy: Phase 2A of theI DEAL 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. 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.

Study Overview

• Status: Not yet recruiting
• Conditions: Hemorrhoidectomy; Minimally Invasive Surgical Technique
• Intervention / Treatment: Procedure: Minimally Invasive hemorrhoidectomy

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

Contacts and Locations

• Study Contact: Name: Ignacio Fernandez-Hurtado, Colorectal Surgeon; Phone Number: 2134 +34 871202000; Email: ifernandez@hsll.es

Study Locations

• Spain
  • Balearic Islands
    • Palma, Balearic Islands, Spain, 07190
      • Hospital Son Llatzer
      • Contact: Ignacio Fernandez-Hurtado, Colorectal Surgeon; Phone Number: 2134 +34 871 202000; 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 CEH 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 intervention

Procedure: Minimally Invasive hemorrhoidectomy; The investigators propose applying minimally invasive surgery in closed excisional hemorrhoidectomy (CEH) , the most effective technique for treating advanced hemorrhoidal disease. The investigators believe this approach will reduce postoperative pain and improve recovery while maintaining the excellent outcomes of CEH. The investigator's hypothesis is based on the reduced tissue trauma and increased precision provided by minimally invasive surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 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
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
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
Clinical Failure Rate	Clinical failure rate (CFR) is defined by the difference in haemorrhoidal symptoms according to Haemorrhoidal Disease Symptom Score and haemorrhoidal disease-related quality of life according to Short Health Scale adapted for Haemorrhoidal Disease comparing baseline and 1-year values. This difference was calculated using the following formula: (baseline Haemorrhoidal Disease Symptom Score - postoperative Haemorrhoidal Disease Symptom Score )/ baseline Haemorrhoidal Disease Symptom Score × 100. The change in quality of life related to haemorrhoidal disease was calculated using the following formula: (baseline Short Health Scale adapted for Haemorrhoidal Disease - postoperative Short Health Scale adapted for Haemorrhoidal Disease.)/baseline Short Health Scale adapted for Haemorrhoidal Disease. × 100. CFR was positive when both criteria showed a ≤50% difference.	one year postoperative

Collaborators and Investigators

• Sponsor: Hospital Son Llatzer

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: April 10, 2026
• First Submitted That Met QC Criteria: April 10, 2026
• First Posted (Actual): April 16, 2026

Study Record Updates

• Last Update Posted (Actual): April 21, 2026
• Last Update Submitted That Met QC Criteria: April 16, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Hemorrhoidectomy; hemorrhoids grade III-IV; IDEAL stage 2A; minimally Invasive Surgical Technique
• Other Study ID Numbers: HEM CLOSE IDEAL 2A

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