دورية أكاديمية
Study Protocol for the Use of Conventional Open Haemorrhoidectomy versus Laser Haemorrhoidoplasty in the Treatment of Symptomatic Haemorrhoids: A Randomized Controlled Trial.
| العنوان: | Study Protocol for the Use of Conventional Open Haemorrhoidectomy versus Laser Haemorrhoidoplasty in the Treatment of Symptomatic Haemorrhoids: A Randomized Controlled Trial. |
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| المؤلفون: | Koh FH; Colorectal Service, Division of Surgery, Sengkang General Hospital, SingHealth Services, Singapore, Singapore, frederickkohhx@gmail.com., Foo FJ; Colorectal Service, Division of Surgery, Sengkang General Hospital, SingHealth Services, Singapore, Singapore., Ho L; Colorectal Service, Division of Surgery, Sengkang General Hospital, SingHealth Services, Singapore, Singapore., Sivarajah SS; Colorectal Service, Division of Surgery, Sengkang General Hospital, SingHealth Services, Singapore, Singapore., Tan WJ; Colorectal Service, Division of Surgery, Sengkang General Hospital, SingHealth Services, Singapore, Singapore., Chew MH; Colorectal Service, Division of Surgery, Sengkang General Hospital, SingHealth Services, Singapore, Singapore. |
| المصدر: | European surgical research. Europaische chirurgische Forschung. Recherches chirurgicales europeennes [Eur Surg Res] 2020; Vol. 61 (6), pp. 201-208. Date of Electronic Publication: 2021 Feb 25. |
| نوع المنشور: | Clinical Trial Protocol; Comparative Study; Journal Article |
| اللغة: | English |
| بيانات الدورية: | Publisher: Karger Country of Publication: Switzerland NLM ID: 0174752 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1421-9921 (Electronic) Linking ISSN: 0014312X NLM ISO Abbreviation: Eur Surg Res Subsets: MEDLINE |
| أسماء مطبوعة: | Original Publication: Basel, New York, Karger. |
| مواضيع طبية MeSH: | Hemorrhoidectomy*, Colorectal Surgery/*methods , Hemorrhoids/*surgery , Laser Therapy/*methods, Humans ; Randomized Controlled Trials as Topic ; Research Design |
| مستخلص: | 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. (© 2021 S. Karger AG, Basel.) |
| فهرسة مساهمة: | Keywords: Haemorrhoidectomy; Haemorrhoids; Laser; Minimally invasive |
| سلسلة جزيئية: | ClinicalTrials.gov NCT04329364 |
| تواريخ الأحداث: | Date Created: 20210225 Date Completed: 20211108 Latest Revision: 20211108 |
| رمز التحديث: | 20240513 |
| DOI: | 10.1159/000513844 |
| PMID: | 33631763 |
| قاعدة البيانات: | MEDLINE |
| تدمد: | 1421-9921 |
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| DOI: | 10.1159/000513844 |