BJS open · 2025
Post-thyroid surgery adhesion prevention using oxidized regenerated cellulose and hyaluronic acid: prospective, single-blinded, randomized study.
СтатьяРандомизированное исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
Обработка статьи · этапы, ошибки и управление
Загрузка состояния…
Ошибки и ограничения
История · было → стало
Состояние обновляется каждые 5 секунд, пока блок открыт. Процент показывается только там, где известен объём работы. Пауза останавливает продолжение этапа; текущий запрос к источнику может завершиться.
Kuo Ting-Chun, Chen Kuen-Yuan, Tsai Yi-Jhih, Lin Ming-Tsan, Chang Chin-Hao, Wu Ming-Hsun
Аннотация
BACKGROUND: Postoperative adhesions following thyroidectomy significantly affect patient quality of life, yet prevention strategies remain understudied. This trial evaluated the safety and efficacy of oxidized regenerated cellulose and high molecular weight hyaluronic acid in preventing post-thyroidectomy adhesions.
METHODS: In this prospective, single-blinded, randomized study, patients undergoing thyroidectomy were randomized 1 : 1 : 1 to receive oxidized regenerated cellulose (Interceed™), high molecular weight hyaluronic acid (HANBIO BarriGel), or no adhesion barrier (control). The primary outcome was change in the Dysphagia Handicap Index (DHI) from baseline to 1 month. Secondary outcomes included the Voice Handicap Index, Swallowing Impairment Score, laryngotracheal elevation, and adhesion severity scores at 2 weeks, and 1, 6, and 12 months after operation.
RESULTS: Forty -five patients were enrolled. Changes in DHI were not significant from baseline to 1 month among the three groups. The adhesion barrier groups demonstrated significantly smaller increases in Voice Handicap Index scores compared with the control group at 2 weeks (oxidized regenerated cellulose: mean(s.d.) 4.8(5.8); high molecular weight hyaluronic acid: 0.8(6.3); control: 8.4(9.6); P = 0.032) and at 1 month (3.0(5.2), 1.0(7.1), and 9.1(12.3), respectively; P = 0.047). Changes in Swallowing Impairment Scores were significantly lower in the adhesion barrier groups (2.1(5.6) versus 6.0(5.9); P = 0.037), although no significant differences were observed among the three groups (oxidized regenerated cellulose: 1.4(4.2); high molecular weight hyaluronic acid: 2.8(6.8); control: 6.0(5.9); P = 0.095) at 2 weeks. The high molecular weight hyaluronic acid group demonstrated superior preservation of laryngotracheal elevation among groups (P = 0.006) and compared with the oxidized regenerated cellulose group (P = 0.041) at 1 month. No adhesion barrier-related complications were observed. By 6 months, most parameters had returned to near-baseline levels across all groups.
CONCLUSION: Both oxidized regenerated cellulose and high molecular weight hyaluronic acid appear safe and potentially effective in reducing early post-thyroidectomy adhesion symptoms, with high molecular weight hyaluronic acid showing superior outcomes in certain parameters. These findings support the use of adhesion barriers in thyroid surgery, although larger studies are needed to confirm their long-term benefits.
REGISTRATION NUMBER: NCT05851560 (http://www.clinicaltrials.gov).
METHODS: In this prospective, single-blinded, randomized study, patients undergoing thyroidectomy were randomized 1 : 1 : 1 to receive oxidized regenerated cellulose (Interceed™), high molecular weight hyaluronic acid (HANBIO BarriGel), or no adhesion barrier (control). The primary outcome was change in the Dysphagia Handicap Index (DHI) from baseline to 1 month. Secondary outcomes included the Voice Handicap Index, Swallowing Impairment Score, laryngotracheal elevation, and adhesion severity scores at 2 weeks, and 1, 6, and 12 months after operation.
RESULTS: Forty -five patients were enrolled. Changes in DHI were not significant from baseline to 1 month among the three groups. The adhesion barrier groups demonstrated significantly smaller increases in Voice Handicap Index scores compared with the control group at 2 weeks (oxidized regenerated cellulose: mean(s.d.) 4.8(5.8); high molecular weight hyaluronic acid: 0.8(6.3); control: 8.4(9.6); P = 0.032) and at 1 month (3.0(5.2), 1.0(7.1), and 9.1(12.3), respectively; P = 0.047). Changes in Swallowing Impairment Scores were significantly lower in the adhesion barrier groups (2.1(5.6) versus 6.0(5.9); P = 0.037), although no significant differences were observed among the three groups (oxidized regenerated cellulose: 1.4(4.2); high molecular weight hyaluronic acid: 2.8(6.8); control: 6.0(5.9); P = 0.095) at 2 weeks. The high molecular weight hyaluronic acid group demonstrated superior preservation of laryngotracheal elevation among groups (P = 0.006) and compared with the oxidized regenerated cellulose group (P = 0.041) at 1 month. No adhesion barrier-related complications were observed. By 6 months, most parameters had returned to near-baseline levels across all groups.
CONCLUSION: Both oxidized regenerated cellulose and high molecular weight hyaluronic acid appear safe and potentially effective in reducing early post-thyroidectomy adhesion symptoms, with high molecular weight hyaluronic acid showing superior outcomes in certain parameters. These findings support the use of adhesion barriers in thyroid surgery, although larger studies are needed to confirm their long-term benefits.
REGISTRATION NUMBER: NCT05851560 (http://www.clinicaltrials.gov).