Division of Surgery, Department of Clinical and Experimental Medicine, Faculty of Health Sciences, University Hospital Linköping, 581 85, Linköping, Sweden.
Department of Surgery, County Council of Östergötland, Linköping, Sweden.
BMC Surg. 2023 Apr 21;23(1):96. doi: 10.1186/s12893-023-01984-x.
There are no prospective trials comparing the two main reconstructive options after colectomy for Ulcerative colitis, ileal pouch anal anastomosis and ileorectal anastomosis. An attempt on a randomized controlled trial has been made but after receiving standardized information patients insisted on choosing operation themselves.
Adult Ulcerative colitis patients subjected to colectomy eligible for both ileal pouch anastomosis and ileorectal anastomosis are asked to participate and after receiving standardized information the get to choose reconstructive method. Patients declining reconstruction or not considered eligible for both methods will be followed as controls. The CRUISE study is a prospective, non-randomized, multi-center, open-label, controlled trial on satisfaction, QoL, function, and complications between ileal pouch anal anastomosis and ileorectal anastomosis.
Reconstruction after colectomy is a morbidity-associated as well as a resource-intensive activity with the sole purpose of enhancing function, QoL and patient satisfaction. The aim of this study is to provide the best possible information on the risks and benefits of each reconstructive treatment.
ClinicalTrials.gov Identifier: NCT05628701.
溃疡性结肠炎患者接受结肠切除术,目前尚无前瞻性试验比较回肠储袋肛门吻合术和回肠直肠吻合术这两种主要的重建选择。我们曾尝试进行一项随机对照试验,但在提供标准化信息后,患者坚持自行选择手术。
接受结肠切除术且有资格进行回肠储袋吻合术和回肠直肠吻合术的成年溃疡性结肠炎患者被邀请参与研究,并在收到标准化信息后选择重建方法。拒绝重建或不符合两种方法适应证的患者将作为对照组进行随访。CRUISE 研究是一项前瞻性、非随机、多中心、开放性、对照临床试验,旨在比较回肠储袋肛门吻合术和回肠直肠吻合术在满意度、生活质量、功能和并发症方面的差异。
结肠切除术后的重建是一种与发病率相关且资源密集型的活动,其唯一目的是增强功能、生活质量和患者满意度。本研究旨在提供有关每种重建治疗的风险和获益的最佳信息。
ClinicalTrials.gov 标识符:NCT05628701。