West China School of Nursing, Sichuan University/ Department of Integrated Traditional Chinese and Western Medicine, West China Hospital, Sichuan University, Chengdu, Sichuan, China.
Cheng Du Shang Jin Nan Fu Hospital, West China Hospital, Sichuan University, Chengdu, Sichuan, China.
Trials. 2021 Nov 13;22(1):797. doi: 10.1186/s13063-021-05750-3.
Pressure dressings have been used after open hemorrhoidectomy to protect surgical wounds and manage postoperative bleeding for many years. However, pressure dressings may increase the incidence of postoperative complications, such as urinary retention, medical adhesive-related skin injury, and pain. A previous controlled trial included 67 patients who underwent Milligan-Morgan hemorrhoidectomy. The data indicated that the use of a nonpressure dressing after hemorrhoidectomy reduces the incidence of urinary retention and catheterization. However, the incidence of severe postoperative bleeding and other postoperative complications was not assessed. There is no consensus on whether it is necessary and beneficial to use a nonpressure dressing after hemorrhoidectomy. The results of this randomized clinical study will help answer this question.
In this study, we plan to include 186 patients who have undergone modified Milligan-Morgan hemorrhoidectomy, which only sutured external hemorrhoids to reduce the risk of bleeding. The purpose is to determine whether the use of nonpressure dressings after open hemorrhoidectomy is inferior to the use of pressure dressings in terms of severe postoperative bleeding and postoperative complications. The primary endpoints of the trial are the incidence of urinary retention within 24 h after surgery and the incidence of severe postoperative bleeding 1 h after dressing removal, which requires revision surgery within 24 h after the surgery. The secondary endpoints of the study are the pain score, anal distension score, postoperative use of analgesics, and incidence of medical adhesive-related skin injury, all of which will be assessed before removing the dressings. The length of hospitalization in days and hospitalization expenses will be recorded. Safety will be assessed with consideration of all adverse and severe adverse events related to the study treatment.
The study received full ethics committee approval. The first patient was enrolled on 27 November 2020. The results of this trial will finally answer the question of whether a nonpressure dressing after open hemorrhoidectomy is necessary and beneficial.
Chinese Clinical Trial Registry ChiCTR2000040283 . Registered on 28 November 2020.
多年来，加压敷料一直被用于痔切除术以保护手术伤口和控制术后出血。然而，加压敷料可能会增加术后并发症的发生率，如尿潴留、医用胶粘剂相关皮肤损伤和疼痛。一项先前的对照试验纳入了 67 例接受痔切除术的患者。数据表明，痔切除术后使用非加压敷料可降低尿潴留和导尿的发生率。然而，并未评估严重术后出血和其他术后并发症的发生率。目前对于痔切除术后是否有必要和有益使用非加压敷料尚未达成共识。本随机临床试验的结果将有助于回答这个问题。
本研究计划纳入 186 例接受改良痔切除术（仅缝合外痔以降低出血风险）的患者。目的是确定痔开放手术后使用非加压敷料是否在严重术后出血和术后并发症方面劣于使用加压敷料。试验的主要终点为术后 24 小时内尿潴留的发生率和术后 1 小时内敷料去除后严重出血的发生率，需要在手术后 24 小时内进行再次手术。研究的次要终点为疼痛评分、肛门扩张评分、术后使用镇痛药以及医用胶粘剂相关皮肤损伤的发生率，所有这些指标都将在去除敷料前进行评估。住院天数和住院费用也将被记录。安全性将根据与研究治疗相关的所有不良事件和严重不良事件进行评估。
该研究获得了伦理委员会的全面批准。首例患者于 2020 年 11 月 27 日入组。本试验的结果最终将回答痔开放手术后使用非加压敷料是否有必要和有益的问题。
中国临床试验注册中心 ChiCTR2000040283 ，于 2020 年 11 月 28 日注册。
