A pragmatic multicentre randomised controlled trial comparing stapled haemorrhoidopexy to traditional excisional surgery for haemorrhoidal disease

Co-sponsored by University of Aberdeen (UK) and NHS Highland0 个研究点目标入组 800 人开始时间: 2010年3月8日最近更新: 2018年3月19日

适应症

试验速览

•Current inclusion criteria as of 02/01/2011:
•1. Patient with circumferential haemorrhoids grade II, III and IV
•2. Patients aged 18 years or older
•3. Written informed consent obtained
•Previous inclusion criteria:
•1. Patients with haemorrhoids grade II who have failed traditional therapy (rubber band ligation [RBL]), haemorrhoids grade III and IV
•2. Patients aged 18 years or older, either sex
•3. Written informed consent obtained

•Current exclusion criteria as of 01/02/2011:
•1. Previous surgery for haemorrhoids (traditional or stapled) (except rubber band ligation (RBL) or Haemorrhoidal Artery Ligation Operation (HALO))
•2. Pre-existing sphincter injury
•3. Peri-anal sepsis
•4. Inflammatory bowel disease
•5. Malignant colorectal disease
•6. Medically unfit for surgery or completion of the trial
•7. Pregnant women
•Previous exclusion criteria:
•1. Previous surgery for haemorrhoids (except RBL for grade II)

发起方

Co-sponsored by University of Aberdeen (UK) and NHS Highland