Trial reportFrontiers in surgery2026
Paeoniflorin adjunct to scar release surgery for postoperative anorectal stenosis: a randomized controlled trial.
Trial report in Frontiers in surgery, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
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Authors and funding
8 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Background: Postoperative anorectal stenosis is a disabling complication of anorectal surgery, characterized by fibrotic narrowing that impairs defecation and quality of life. While scar-release surgery can restore lumen patency, long-term outcomes are undermined by recurrent fibrosis. Paeoniflorin, the active component of Shaobei Injection, is a promising botanical antifibrotic agent that may enhance perioperative efficacy. This study aims to evaluate whether combining Paeoniflorin with longitudinal scar-release surgery improves anatomical and functional outcomes in patients with postoperative anorectal stenosis compared to surgery alone. Methods: In this prospective, multicenter randomized controlled trial (Trial registration: ChiCTR2200062631) in China. Eligible patients with iatrogenic fibrotic anorectal stenosis were randomized equally (1:1) to receive either scar-release surgery plus Paeoniflorin (experimental group) or surgery alone (control group). The primary endpoints were stricture relief rate (defined as anal canal diameter ≥20 mm) and improvement in defecation difficulty score at 1 and 6 months. Secondary outcomes included anal pain (VAS), scar tissue thickness (imaging), and stricture recurrence rate. All patients were followed for 6 months. Results: A total of 128 patients were enrolled and randomized (64 per group); after excluding 22 patients lost to follow-up, 106 patients (53 per group) completed the 6-month follow-up and were included in the final analysis. At 6 months, the stricture relief rate was significantly higher in the experimental group compared to the control group (90.6% vs. 73.6%; Conclusions: These preliminary 6-month findings suggest that local paeoniflorin may provide exploratory benefits as an adjunct to scar-release surgery. Larger, longer-term trials are required to validate its clinical efficacy and durability. Clinical Trial Registration: https://www.chictr.org.cn/, ChiCTR2200062631.
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