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MINIMALLY INVASIVE SURGERY FOR GRADE III HEMORRHOIDS - Observational Study NCT07534761

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Summary

NIH ClinicalTrials.gov registered a new observational study (NCT07534761) evaluating minimally invasive surgery (MIS) for Grade III hemorrhoids using a closed excisional hemorrhoidectomy technique. The IDEAL Phase 2a study aims to assess reproducibility and technical feasibility of MIS in anal surgery with approximately 50 participants.

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What changed

This document registers a new observational clinical study on ClinicalTrials.gov investigating minimally invasive surgery for Grade III hemorrhoid treatment. The study uses the IDEAL Phase 2a framework to evaluate reproducibility of the technique, which employs enhanced visualization devices to improve surgical precision and reduce tissue damage compared to standard closed excisional hemorrhoidectomy.

For compliance and clinical operations teams, this represents an emerging area of surgical innovation that may inform future clinical practice guidelines. Healthcare providers conducting or considering similar surgical techniques should monitor this study for outcomes data that could influence standard-of-care considerations.

What to do next

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Archived snapshot

Apr 16, 2026

GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.

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MINIMALLY INVASIVE SURGERY FOR GRADE III HEMORRHOIDS

Observational NCT07534761 Kind: OBSERVATIONAL Apr 16, 2026

Abstract

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 cl...

Conditions: Hemorrhoidectomy, Minimally Invasive Surgical Technique

Interventions: Minimally Invasive hemorrhoidectomy

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Last updated

Classification

Agency
NIH
Published
April 16th, 2026
Instrument
Notice
Legal weight
Non-binding
Stage
Final
Change scope
Minor
Document ID
NCT07534761
Docket
NCT07534761

Who this affects

Applies to
Healthcare providers Clinical investigators
Industry sector
6211 Healthcare Providers
Activity scope
Clinical trial registration Surgical technique evaluation
Geographic scope
United States US

Taxonomy

Primary area
Healthcare
Operational domain
Clinical Operations
Topics
Medical Devices Clinical Operations

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