Berdah Stéphane V, Mariette Christophe, Denet Christine, Panis Yves, Laurent Christophe, Cotte Eddy, Huten Nöel, Le Peillet Feuillet Eliane, Duron Jean-Jacques
Chirurgie Digestive, Hôpital Nord, CERC (Centre d'Enseignement et de Recherche Chirurgical), Aix-Marseille Université, Chemin des Bourrellys, 13915 Marseille, Cedex 20, France.
Trials. 2014 Oct 27;15:413. doi: 10.1186/1745-6215-15-413.
Intra-peritoneal adhesions are frequent following abdominal surgery and are the most common cause of small bowel obstructions. A hyaluronic acid/carboxymethylcellulose (HA/CMC) film adhesion barrier has been shown to reduce adhesion formation in abdominal surgery. An HA/CMC powder formulation was developed for application during laparoscopic procedures.
This was an exploratory, prospective, randomised, single-blind, parallel-group, Phase IIIb, multicentre study conducted at 15 hospitals in France to assess the safety of HA/CMC powder versus no adhesion barrier following laparoscopic colorectal surgery. Subjects ≥18 years of age who were scheduled for colorectal laparoscopy (Mangram contamination class I‒III) within 8 weeks of selection were eligible, regardless of aetiology. Participants were randomised 1:1 to the HA/CMC powder or no adhesion barrier group using a centralised randomisation list. Patients assigned to HA/CMC powder received a single application of 1 to 10 g on adhesion-prone areas. In the no adhesion barrier group, no adhesion barrier or placebo was applied. The primary safety assessments were the incidence of adverse events, serious adverse events, and surgical site infections (SSIs) for 30 days following surgery. Between-group comparisons were made using Fisher's exact test.
Of those randomised to the HA/CMC powder (n = 105) or no adhesion barrier (n = 104) groups, one patient in each group discontinued prior to the study end (one death in each group). Adverse events were more frequent in the HA/CMC powder group versus the no adhesion barrier group (63% vs. 39%; P <0.001), as were serious adverse events (28% vs. 11%; P <0.001). There were no statistically significant differences between the HA/CMC powder group and the no adhesion barrier group in SSIs (21% vs. 14%; P = 0.216) and serious SSIs (12% vs. 9%; P = 0.38), or in the most frequent serious SSIs of pelvic abscess (5% and 2%; significance not tested), anastomotic fistula (3% and 4%), and peritonitis (2% and 3%).
This exploratory study found significantly higher rates of adverse events and serious adverse events in the HA/CMC powder group compared with the no adhesion barrier group in laparoscopic colorectal resection.
ClinicalTrials.gov NCT00813397. Registered 19 December 2008.
腹腔粘连在腹部手术后很常见，是小肠梗阻最常见的原因。透明质酸/羧甲基纤维素（HA/CMC）薄膜粘连屏障已被证明可减少腹部手术中粘连的形成。一种HA/CMC粉末制剂已被开发用于腹腔镜手术。
这是一项在法国15家医院进行的探索性、前瞻性、随机、单盲、平行组、IIIb期多中心研究，旨在评估HA/CMC粉末与腹腔镜结直肠手术后不使用粘连屏障相比的安全性。入选后8周内计划进行结直肠腹腔镜检查（Mangram污染分级I‒III）的18岁及以上受试者符合条件，无论病因如何。使用集中随机列表将参与者按1:1随机分配至HA/CMC粉末组或不使用粘连屏障组。分配至HA/CMC粉末组的患者在易发生粘连的部位单次应用1至10 g。在不使用粘连屏障组中，不应用粘连屏障或安慰剂。主要安全性评估为术后30天内不良事件、严重不良事件和手术部位感染（SSI）的发生率。组间比较采用Fisher精确检验。
随机分配至HA/CMC粉末组（n = 105）或不使用粘连屏障组（n = 104）的患者中，每组各有1例患者在研究结束前退出（每组各有1例死亡）。HA/CMC粉末组的不良事件比不使用粘连屏障组更频繁（63%对39%；P <0.001），严重不良事件也是如此（28%对11%；P <0.001）。HA/CMC粉末组与不使用粘连屏障组在SSI（21%对14%；P = 0.216）和严重SSI（12%对9%；P = 0.38）方面，以及在最常见的严重SSI盆腔脓肿（5%和2%；未检验显著性）、吻合口瘘（3%和4%）和腹膜炎（2%和3%）方面，均无统计学显著差异。
这项探索性研究发现，在腹腔镜结直肠切除术中，HA/CMC粉末组的不良事件和严重不良事件发生率显著高于不使用粘连屏障组。
ClinicalTrials.gov NCT00813397。2008年12月19日注册。
