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
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. 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
View:

• Age over 18 years

• Grade III hemorrhoids

• BMI below 30

• Indication for OEH surgery

• Signed written informed consent

Locations
Other Locations
Spain
Hospital Son Llatzer
Palma
Time Frame
Start Date: 2025-05-01
Completion Date: 2025-08-01
Participants
Target number of participants: 5
Treatments
Grade III Hemorrhoids
Patients with symptomatic grade III hemorrhoids who consent to surgical intervention
Related Therapeutic Areas
Sponsors
Leads: Hospital Son Llatzer

This content was sourced from clinicaltrials.gov