Minimally invasive hemorrhoidectomy for grade III/IV hemorrhoids
Official title: Prospective Observational Study to Assess the Reproducibility of Minimally Invasive Surgery in Closed Excisional Hemorrhoidectomy: Phase 2A of theI DEAL Framework
Run by Hospital Son Llatzer · NCT07534761 · Data updated 2026-11-12
This study tests a minimally invasive hemorrhoidectomy technique in adults with grade III or IV hemorrhoids to see if it provides relief with less pain than traditional methods.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 50 (estimated) |
| Sponsor | Hospital Son Llatzer Academic / other |
| Locations | 1 site (Palma, Balearic Islands) |
| Status | Recruiting |
| Started | June 1, 2026 |
| Main results expected | December 1, 2026 |
| Study ends | December 1, 2027 |
| Registry record updated | September 22, 2026 |
| Trial ID | NCT07534761 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults over 18 with Goligher grade III or IV hemorrhoids who require surgical hemorrhoidectomy and consent to participate.
✕Probably not a fit
Patients with acute hemorrhoidal thrombosis, prior hemorrhoid surgery, coexisting anorectal conditions, inflammatory bowel disease, active cancer, or language barriers may not experience benefit from this specific approach.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study investigates a minimally invasive approach to hemorrhoidectomy for patients with Goligher grade III–IV hemorrhoids who require surgery. The procedure uses enhanced visualization and precision to reduce tissue injury compared with standard excisional methods. It aims to document safety, feasibility, and postoperative pain, healing, and recovery within the IDEAL framework for surgical innovation. Participants are adults undergoing surgery at Hospital Son Llatzer in Palma, with careful inclusion and exclusion criteria to select appropriate candidates. Data will describe outcomes and inform future refinement and broader evaluation of the technique.
Why it matters
Potential benefit: If successful, patients may experience less postoperative pain and improved healing after hemorrhoidectomy with the minimally invasive approach.
How similar studies have gone: Previous work shows MIS benefits in other surgical fields, but its use in anal surgery is novel and exploratory.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Hospital Son Llatzer
Palma, Balearic Islands, Spain Recruiting
Study contacts
- Study coordinator: Ignacio Fernandez-Hurtado, Colorectal Surgeon
- Email: ifernandez@hsll.es
- Phone: +34 871202000
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.