Faculty of Clinical Medicine and Dentistry, Department of Surgery, Kampala International University Western Campus, Ishaka-Bushenyi, Uganda.
Faculty of Medicine, Université Catholique du Graben, Butembo, Democratic Republic of the Congo.
Trials. 2022 Aug 13;23(1):652. doi: 10.1186/s13063-022-06636-8.
While open hemorrhoidectomy under local anesthesia has been shown to be more cost-effective with shorter operation times and lower complication rates, local anesthesia is still not considered as a first-line technique in low-income countries like Uganda. The objective of this trial is to compare open hemorrhoidectomy using local anesthesia versus saddle block among patients with primary uncomplicated 3rd- or 4th-degree hemorrhoids in western Uganda.
The protocol for a prospective equivalence randomized, double-blind controlled trial was conducted among patients with primary uncomplicated 3rd- or 4th-degree hemorrhoids. Recruitment was started in December 2021 and is expected to end in May 2022. Consenting participants who require open hemorrhoidectomy indicated at Kampala International Teaching Hospital, Uganda, will be randomized into two groups of 29 patients per arm.
The primary outcome of this study is to compare the occurrences of postoperative pain following open hemorrhoidectomy using the visual analog scale in an interval of 2, 4, and 6 h and 7 days postoperatively. Furthermore, the mean operative time from the induction of anesthesia to the end of the surgical procedure as well as the cost-effectiveness of the 2 techniques will be assessed in both groups. Open hemorrhoidectomy under local anesthesia has the potential to offer benefits to patients but most importantly expediting return to baseline and functional status, shorter hospital stay by meeting the faster discharge criteria, and reduction in costs associated with reduced length of stay and complications.
Pan African Clinical Trials Registry PACTR202110667430356. Registered on 8 October 2021.
虽然在局部麻醉下进行开放式痔切除术具有手术时间更短、并发症发生率更低、成本效益更高的优势，但在乌干达等低收入国家，局部麻醉仍未被视为一线技术。本试验旨在比较在乌干达西部，局部麻醉下开放式痔切除术与鞍状阻滞麻醉在原发性单纯 3 或 4 度痔患者中的效果。
该前瞻性等效随机、双盲对照试验方案在原发性单纯 3 或 4 度痔患者中进行。招募工作于 2021 年 12 月开始，预计将于 2022 年 5 月结束。在乌干达坎帕拉国际教学医院需要开放式痔切除术的同意参与者将被随机分为两组，每组 29 名患者。
本研究的主要结局是比较在术后 2、4、6 小时和 7 天间隔内使用视觉模拟量表评估的开放式痔切除术后疼痛的发生情况。此外，还将评估两组患者从麻醉诱导到手术结束的平均手术时间以及两种技术的成本效益。局部麻醉下的开放式痔切除术有可能为患者带来益处，但最重要的是通过满足更快出院标准，更快地恢复基线和功能状态，缩短住院时间，降低与住院时间缩短和并发症相关的成本。
泛非临床试验注册处 PACTR202110667430356。注册于 2021 年 10 月 8 日。
