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Prospective Observational Study to Assess the Reproducibility of Ferguson's Minimally Invasive Hemorrhoidectomy in the Treatment of Grade III Hemorrhoids: Phase 2a of the IDEAL Framework

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Observational
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. Excisional hemorrhoidectomy is the standard procedure. There are two main options: without wound closure (Milligan-Morgan technique) and with wound closure (Ferguson technique). Both options are effective in the long term and cause severe postoperative pain, although comparative studies between Milligan-Morgan and Ferguson hemorrhoidectomy have shown that the Ferguson technique is associated with less postoperative pain and better early wound healing, while maintaining similar long-term efficacy. 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 scarcely been explored in anal surgery. Its potential advantages include reduced tissue injury and improved healing, although it entails a learning curve and may initially prolong operative time. The IDEAL framework evaluates surgical innovations in five stages: Idea, Development, Exploration, Evaluation, and Long-Term Study. IDEAL phase 2a focuses on the optimization and technical definition of a surgical innovation, emphasizing continuous improvement based on real clinical practice and laying the foundation for broader and more rigorous subsequent studies. Since no previous studies on the application of MIS in closed Ferguson hemorrhoidectomy have been identified, the investigators propose a phase 2a IDEAL study to assess the reproducibility of this minimally invasive adaptation. The investigators hypothesize that incorporating MIS into the Ferguson technique could further reduce postoperative pain and accelerate recovery, while preserving the well-established effectiveness of closed hemorrhoidectomy in advanced hemorrhoidal disease.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age over 18 years

• Grade III-IV hemorrhoids

• Indication for excisional hemorrhoidectomy surgery

• Signed written informed consent

Locations
Other Locations
Spain
Hospital Son Llatzer
RECRUITING
Palma De Mallorca
Contact Information
Primary
Ignacio Fernandez_Hurtado, MD
ifernandez@hsll.es
+34871202000
Time Frame
Start Date: 2026-06-15
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 50
Treatments
Grade III-IV Hemorrhoids
Patients with symptomatic grade III-IV hemorrhoids who consent to surgical interv
Related Therapeutic Areas
Sponsors
Leads: Hospital Son Llatzer

This content was sourced from clinicaltrials.gov