Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO

Objective:The study aims to evaluate the safety and performance of Mirus™ Hemorrhoidal Circular Stapler.

Hemorrhoidal disease is one of the most common conditions identified in outpatient clinics, resulting in 3.3 million outpatient visits annually in the U.S., with a self-reported incidence of 10 million cases per year, affecting 4.4% of the population 

Currently, treatment options for hemorrhoidal disease (HD) range from conservative approaches, such as dietary changes and medications, to non-excisional methods like cryotherapy, sclerotherapy, laser photocoagulation, and rubber band ligation. For advanced cases, particularly grade III or IV hemorrhoids, or when conservative treatments fail in patients with persistent bleeding, surgical excision may be necessary .

Surgery is the most effective treatment for hemorrhoids and is particularly recommended for grade IV hemorrhoids (irreducible) and prolapsing hemorrhoids during defecation that may be manually reduced .

Traditional hemorrhoidal surgery, including Ferguson’s and Milligan-Morgan procedures, effectively removes hemorrhoids but causes significant postoperative pain due to external wounds. Stapled hemorrhoidopexy, introduced by Longo, has gained widespread acceptance for causing less pain and enabling faster recovery. This technique utilizes a specially designed circular stapling device that differs from traditional circular staplers used for creating full-thickness anastomoses .

Pain is the most common complication following hemorrhoidectomy procedures. Long-term complications include anal fissure, anal stenosis, incontinence, fistula, and hemorrhoidal recurrence. The significant pain associated with hemorrhoidectomies represents a major clinical concern .

The recently introduced laser hemorrhoidoplasty technique has been successfully applied to patients with hemorrhoids of all degrees. This method delivers laser energy into the interstitial tissue rather than the perianal vessels, resulting in tissue retraction and hemorrhoidal resolution. The technique produces less intense, shorter-duration pain and achieves satisfactory long-term outcomes. The distinctive feature of laser hemorrhoidoplasty is that the coagulated area remains invisible during the procedure since it lies beneath the healthy, uninjured mucosal layer.