常规开放式痔切除术与激光痔切除术治疗症状性痔的研究方案：一项随机对照试验。

Study Protocol for the Use of Conventional Open Haemorrhoidectomy versus Laser Haemorrhoidoplasty in the Treatment of Symptomatic Haemorrhoids: A Randomized Controlled Trial.

机构信息

Colorectal Service, Division of Surgery, Sengkang General Hospital, SingHealth Services, Singapore, Singapore,

Colorectal Service, Division of Surgery, Sengkang General Hospital, SingHealth Services, Singapore, Singapore.

出版信息

Eur Surg Res. 2020;61(6):201-208. doi: 10.1159/000513844. Epub 2021 Feb 25.

DOI:10.1159/000513844

PMID:33631763

Abstract

BACKGROUND

Haemorrhoids result in a variety of symptoms that cause significant patient anxiety. Treatment has long been associated with post-operative complications, which cause significant symptoms and may result in readmissions. The open conventional haemorrhoidectomy (COH) is still regarded as the gold standard treatment for non-circumferential grade II-IV haemorrhoids. Laser haemorrhoidoplasty (LAH) has recently been studied and the initial results appear promising. This study aims to compare these 2 techniques in the treatment of symptomatic haemorrhoids. We hypothesize that LAH has significantly less pain and bleeding and better quality of life (QoL) scores 1, 3 and 12 months post-operatively.

METHODS

A prospective, randomized, double-blind, single-centre clinical trial will be conducted. All patients aged between 21 and 90 years who present with symptomatic grade II-IV haemorrhoids will be recruited. Exclusion criteria include those who have had previous operations for haemorrhoids and those with an increased risk of bleeding. Data collected will include patient demographics, pre- and intra-operative characteristics of the haemorrhoids, operative details and post-operative pain Visual Analogue Scale (VAS) score, complications, readmissions, and haemorrhoid-specific QoL surveys. Primary outcome will be median post-operative pain VAS score on post-operative days (POD) 1-10. Secondary outcomes include operative duration, bleeding on the first 10 days post-operatively, readmissions, procedure-related complications (fistulation, incontinence, stenosis), QoL scores, and recurrence of symptoms up to 12 months.

DISCUSSION

Results from this trial may demonstrate the superiority of LAH over COH in terms of post-operative pain and recovery. This would likely increase the adoption of LAH for the treatment of symptomatic haemorrhoids.

TRIAL REGISTRATION

This trial was registered on 1/4/2020 at ClinicalTrials.gov. URL: https://www.clinicaltrials.gov/ct2/show/NCT04329364?term=NCT04329364&draw=2&rank=1.

摘要

背景

痔疮会引起各种症状，导致患者焦虑不安。长期以来，痔疮的治疗一直与术后并发症相关，这些并发症会引起明显的症状，并可能导致再次入院。开放式传统痔切除术（COH）仍然被认为是治疗非环状 II-IV 度痔的金标准治疗方法。激光痔切除术（LAH）最近已经被研究过，初步结果似乎很有前景。本研究旨在比较这两种技术在治疗症状性痔疮方面的效果。我们假设 LAH 在术后 1、3 和 12 个月时疼痛和出血明显减少，生活质量（QoL）评分更高。

方法

将进行一项前瞻性、随机、双盲、单中心临床试验。所有年龄在 21 至 90 岁之间、患有症状性 II-IV 度痔疮的患者将被招募。排除标准包括以前曾接受过痔疮手术的患者和有出血风险增加的患者。收集的数据将包括患者的人口统计学特征、痔疮的术前和术中特征、手术细节以及术后疼痛视觉模拟量表（VAS）评分、并发症、再入院和痔疮特异性 QoL 调查。主要结局将是术后 1-10 天的术后疼痛 VAS 评分中位数。次要结局包括手术时间、术后 10 天内的出血、再入院、与手术相关的并发症（瘘管、失禁、狭窄）、QoL 评分以及 12 个月内症状复发情况。