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Recruiting NCT07534761

Minimaly Ivnasive Surgery for Grade III Hemorrhoids

Conditions: Hemorrhoidectomy, Minimally Invasive Surgical Technique

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 50
Sponsor: Hospital Son Llatzer

Location: Hospital Son Llatzer Palma Balearic Islands

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.

Eligibility Criteria

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

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07534761). StuddyBuddy aggregates publicly available trial information.