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Clinical Evaluation of the Lepu Medical PPH Stapler versus the Golden Stapler (XNY) in Hemorrhoidal Disease and Rectal Mucosal Prolapse: A Regulatory Validation Study | ||
| Iranian Journal of Colorectal Research | ||
| دوره 14، شماره 1، خرداد 2026 اصل مقاله (507.04 K) | ||
| نوع مقاله: Research/Original Article | ||
| شناسه دیجیتال (DOI): 10.30476/acrr.2026.110676.1284 | ||
| نویسندگان | ||
| Khadijeh Gorgi؛ Hajar Khazraei* | ||
| Colorectal Research Center, Shiraz University of Medical Sciences, Shiraz, Iran | ||
| چکیده | ||
| Background: Stapled hemorrhoidopexy (PPH) is a well-established surgical procedure for treating high-grade hemorrhoidal disease and rectal mucosal prolapse. Regulatory clinical validation is essential to ensure the device’s safety and performance equivalence. Methods: In this prospective regulatory evaluation, 23 patients underwent PPH using either the Lepu Medical stapler (n=10) or the XNY (Golden Stapler) device (n=13). Intraoperative technical success, surgeon-reported device fluency (5-point scale), hemostasis, postoperative pain (VAS), and early complications during a 3-month follow-up period were assessed. Results: Technical success was achieved in all cases, with complete circumferential staple lines. The XNY stapler demonstrated higher mean fluency scores than the Lepu Medical stapler (4.8 vs. 4.1). Minor staple-line overstitching occurred in 20% and 23% of cases, respectively. Postoperative pain was low, and no anal stenosis, infection, or recurrence was observed after three months. Conclusion: Both staplers provided safe and effective treatment. The XNY stapler demonstrated a statistically significant advantage in fluency scores compared to the Lepu Medical stapler. However, the Lepu Medical stapler met all clinical safety requirements, including pain, recovery, and complication rates, suggesting that its use in routine surgical practice and national healthcare procurement could be as safe as the XNY device. | ||
| کلیدواژهها | ||
| Hemorrhoids؛ Stapled hemorrhoidopexy؛ Rectal mucosal prolapse؛ Surgical staplers؛ Regulatory evaluation | ||
| مراجع | ||
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1. Wang TH, Kiu KT, Yen MH, et al. Comparison of the short-term outcomes of using DST and PPH staplers in the treatment of grade III and IV hemorrhoids. Scientific reports. 2020;10(1):5189. 2. Peeters K ea. Early complications after SH: comparing three staplers. . Acta Chir Belg. 2016;116:151-5. 3. Dindo D, Hahnloser D. Anal mucosectomy for haemorrhoids: should we start to speak Chinese? Colorectal disease : the official journal of the Association of Coloproctology of Great Britain and Ireland. 2013;15(4):e186-9. 4. Reddy SK SV, Patil MB, Biradar D, et al. A Comparative Study Between Stapler Hemorrhoidopexy and Conventional Hemorrhoidectomy. Cureus 2026;18(1). 5. Lauricella S, Brucchi F, Mascianà G, et al. Long-term outcomes of stapled haemorrhoidopexy versus conventional haemorrhoidectomy: An updated systematic review, metaanalysis and trial-sequential analysis of randomized controlled trials. International journal of colorectal disease. 2026;41(1):34. 6. NA. C. A prospective randomized controlled trial to compare the clinical outcomes of triple rows stapler versus double rows stapler in hemorrhoids. . Ann Surg Case Rep Images. 2025;2(2):1093. 7. Betzold R, Laryea JA. Staple line/ anastomotic reinforcement and other adjuncts: do they make a difference? Clinics in colon and rectal surgery. 2014;27(4):156-61. 8. Bove A ea. STARR procedure with two different devices. Am Surg. 2018;84:e242-4. 9. Giuratrabocchetta S, Pecorella G, Stazi A, et al. Safety and short-term effectiveness of EEA stapler vs PPH stapler in the treatment of degree III haemorrhoids: prospective randomized controlled trial. Colorectal disease : the official journal of the Association of Coloproctology of Great Britain and Ireland. 2013;15(3):354-8. 10. Yuan C, Zhou C, Xue R, et al. Outcomes of Modified Tissue Selection Therapy Stapler in the Treatment of Prolapsing Hemorrhoids. Frontiers in surgery. 2022;9:838742. 11. Huang H, Wen K, Ding X, et al. The efficiency and safety of modified tissue-selecting therapy stapler combined with complete anal canal epithelial preservation operation in circumferential mixed hemorrhoids: a randomized controlled trial. Langenbeck’s archives of surgery. 2023;408(1):332. | ||
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