EP312 - PexyEazy®, A Novel Surgical Device For The Treatment of Grade II–III Hemorrhoids: One-Week and Three-Month Results From The SCI-Pex Study.

Purpose/Background: Hemorrhoidal cushions are important for continence of air and liquid, which is why minimally invasive, hemorrhoid-sparing methods are preferred. Current treatments either have high relapse rates, are invasive and tissue-destructive, or cause postoperative pain and prolonged recovery.

Methods/Interventions: PexyEazy® is a single-use device based on mucopexy. The device has a similar diameter to a standard proctoscope and treats all three internal hemorrhoids simultaneously, reducing procedure time and allowing surgery without anesthesia. Hemorrhoids are lifted and fixed internally using sutures placed semi-automatically by the device, restoring their normal position and allowing swelling to subside. The dentate line is identified with a dedicated proctoscope, ensuring suture placement 10 mm above the dentate line where pain sensation is minimal.

To assess safety and feasibility, the non-comparative multicenter SCI-Pex study was conducted at three Swedish sites with six different surgeons. Thirty-two patients (mean age 54, range 28-78) were treated and followed up after one week and three months. All were evaluated for intra- and postoperative adverse events. The first patient at each site was excluded from long-term analysis; two were lost to follow-up, three excluded due to device handling issues, and one due to external hemorrhoids only. Thus, 23 patients completed the three-month evaluation, which included patient reported outcome measures HDSS (Hemorrhoidal Disease Symptom Score) and SHS-HD (Short Health Scale of hemorrhoid symptoms affecting quality of life), as well as clinical inspection.

Results/Outcomes: Five patients underwent the procedure without anesthesia, two with light sedation (low dose of propofol), 14 with propofol sedation and 11 under general anesthesia. No regional blockades with local anesthesia were used. No severe adverse events occurred. Two patients had minor postoperative bleeding (Clavien-Dindo I). Mean NRS pain score after one week was 3.4 and mean sick leave 1 day (1.2). Forty percent used no analgesics, 41% used paracetamol and ibuprofen, and 19% added oxycodone 5mg for up to four days (Median 1(1-2)x1.5(1-2)times/day for 3(1-7)days). Common transient symptoms included mild bleeding (n=10), difficult defecation (n=8), urinary retention, soiling, swelling, or malaise (n=3 each). None of these postoperative symptoms required medical care.

At three months, 71% of the included patients had an improvement of their hemorrhoids by one grade or more and 29% had an unchanged grade of hemorrohoids. None of the patients had a more severe grade of disease. Of the 71% with improvement of their hemorrhoids 53% did not have enlarged hemorrhoids at all. The HDSS score decreased by 52.2% on average, with site variability (sites 1-2: -67.5%; site 3: -17.3%). The SHS-HD improved by 44.7% overall (sites 1-2: -50%; site 3: -31%).

Conclusion/Discussion: PexyEazy® is a novel device for minimally invasive treatment of grade II-III hemorrhoids. This investigation demonstrates that the procedure is safe, feasible in an outpatient setting without general anesthesia or regional anesthesia and associated with low postoperative pain and rapid recovery. The procedure decreases symptoms from hemorrhoids significantly. The variation in decrease of HDSS scores between three sites may be explained by differences in knot tightening. No complications of Clavien Dindo 2 or higher were recorded.