Implementation of Minimally Invasive Surgery for Grade III Hemorrhoids

Recruiting

• Conditions: Hemorrhoidectomy; Minimal Invasive Surgery

• Registration Number: NCT06851312
• Lead Sponsor: Hospital Son Llatzer

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. Open excisional hemorrhoidectomy (OEH), based on the Milligan-Morgan technique, is the standard procedure. 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. In Stage 1, the first application in humans is documented, analyzing outcomes and feasibility.

Since no previous studies on the application of MIS in OEH have been found, the investigators propose a study within Stage 1 of the IDEAL model to assess the feasibility of this technique. The investigators believe its incorporation into open excisional hemorrhoidectomy could result in less postoperative pain and faster patient recovery.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-02-24
• Study First Submitted QC: 2025-02-24
• Study First Posted: 2025-02-28
• Study Start: 2025-05-01
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-04
• Last Update Posted: 2025-06-08
• Primary Completion: 2025-07-01
• Study Completion: 2025-08-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 5

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Technical Feasibility of Surgery	From enrollment to the surgical procedure	Since no studies using this approach were found in the literature, the investigators propose a study to assess the feasibility of implementing this technique following the guidelines of the IDEAL framework. In this study, the investigators propose Stage 1. The measurement tool will be the number of patients in whom the technique could be performed

Trial Locations

Locations (1)

Hospital Son Llatzer; 🇪🇸 Palma, Spain