NCT06851312

Implementation of Minimally Invasive Surgery for Grade III Hemorrhoids

Prospective Observational Study to Assess the Implementation of Minimally Invasive Surgery in the Treatment of Grade III Hemorrhoids: Phase 1 of the IDEAL Framework

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 5 (actual)
• Sponsor: Hospital Son Llatzer · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

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.

Conditions

• Hemorrhoidectomy
• Minimal Invasive Surgery

Interventions

Type	Name	Description
PROCEDURE	Minimal invasive hemorrhoidectomy	We propose applying minimally invasive surgery in open excisional hemorrhoidectomy, 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 OEH. Our hypothesis is based on the reduced tissue trauma and increased precision provided by minimally invasive surgery.

Timeline

• Start date: 2025-05-01
• Primary completion: 2025-07-01
• Completion: 2025-08-01
• First posted: 2025-02-28
• Last updated: 2025-08-27

Locations

1 site across 1 country: Spain