Reduction of de novo postsurgical adhesions by intraoperative precoating with Sepracoat* (HAL-C) solution: a prospective, randomized, blinded, placebo-controlled multicenter study
Reduction of de novo postsurgical adhesions by intraoperative precoating with Sepracoat* (HAL-C) solution: a prospective, randomized, blinded, placebo-controlled multicenter study
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DOI：
10.1016/s0015-0282(98)00057-0
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发表时间：
1998-06-01
影响因子：
6.7
通讯作者：
Diamond, MP
中科院分区：
文献类型：
--
作者：
Diamond, MP
目的：评价Seprecoat(HAL-C；Genzyme Corporation，Cambridge，MA)溶液在减少妇科开腹手术中无直接手术创伤或粘连溶解的部位再次粘连形成的发生率、严重程度和程度方面的有效性和安全性。设计：前瞻性、随机、盲法、安慰剂对照的多中心研究。患者通过开腹手术进行妇科手术；大约40天后，外科医生在第二次腹腔镜检查中评估他们的粘连。地点：23家北美机构。患者(S)：277名妇女进行安全性评估；2 45名妇女进行疗效研究。干预(S)：术中浆膜涂抹Seproat(治疗)或磷酸盐缓冲盐水(安慰剂)后，开腹后，术中每30分钟或手术结束时。主要观察指标(S)：23个腹部部位的粘连发生率、严重程度和程度。结果(S)：Seproat组的粘连发生率显著低于安慰剂组(0.23+/-0.02比0.30+/-0.02，P<0.05)。)和未发生粘连的患者百分比(分别为13.1%和4.6%)，并显著降低粘连程度和严重程度。塞普考特耐受性良好，安全性几乎与安慰剂相同。结论：塞普考特明显比安慰剂有效，并能安全地降低妇科手术后间接损伤的多个部位经剖腹手术后再次粘连的发生率、程度和严重程度。(C)1998年由美国生殖医学学会主办。
Objective: To assess the efficacy and safety of Sepracoat (HAL-C; Genzyme Corporation, Cambridge, MA) solution in reducing the incidence, severity, and extent of de novo adhesion formation at sites without direct surgical trauma or adhesiolysis at the time of gynecologic laparotomy.Design: Prospective, randomized, blinded, placebo-controlled multicenter study. Patients underwent gynecologic proce dures via laparotomy; approximately 40 days later, surgeons assessed their adhesions during second-look laparoscopy.Setting: Twenty-three North American institutions.Patient(s): Two hundred seventy-seven women for safety evaluations; 245 women for efficacy studies.Intervention(s): Intraoperative serosal coating with Sepracoat (treatment) or phosphate-buffered saline (placebo) after opening of the abdominal cavity, after irrigation or every 30 minutes during surgery, and at the completion of surgery.Main Outcome Measure(s): Incidence, severity, and extent of de novo adhesions to 23 intraabdominal sites.Result(s): The Sepracoat group had a significantly lower incidence of de novo adhesions than the placebo group as assessed by the proportion of sites involved (0.23 +/- 0.02 versus 0.30 +/- 0.02, respectively) and the percentage of patients without de novo adhesions (13.1% versus 4.6%, respectively), as well as significantly reduced adhesion extent and severity. Sepracoat was well tolerated, with a safety profile nearly identical to that of the placebo.Conclusion(s): Sepracoat was significantly more effective tha n placebo and was safe in reducing the incidence, extent, and severity of de novo adhesions to multiple sites indirectly traumatized by gynecologic surgery via laparotomy. (C) 1998 by American Society for Reproductive Medicine.