TY - JOUR
T1 - HollAND trial: Comparison of rubber band ligation and haemorrhoidectomy in patients with symptomatic haemorrhoids grade III: Study protocol for a multicentre, randomised controlled trial and cost-utility analysis
AU - Dekker, Lisette
AU - Han-Geurts, Ingrid J. M.
AU - van Dieren, Susan
AU - Bemelman, Willem A.
N1 - Funding Information: Contributors IJMH-G, WAB and SvD all contributed to conception and design of this trial protocol. IJMH-G and WAB initiated the project and are de chief investigators. The protocol was drafted by IJMH-G and was refined by WAB. Statistical advice was provided by SvD. LD was responsible for drafting the manuscript. All authors read and approved the final manuscript. Funding The study is supported by The Netherlands Organization for Health Research and Development (ZonMw), Leading the Change programme (grant number 80-85009-98-2001). Trial sponsor: Proctos Kliniek, professor Bronkhorstlaan 10, 3723 MB Bilthoven, the Netherlands. Publisher Copyright: © 2021 BMJ Publishing Group. All rights reserved. Copyright: Copyright 2021 Elsevier B.V., All rights reserved.
PY - 2021/4/8
Y1 - 2021/4/8
N2 - Introduction Haemorrhoidal disease is one of the most common anorectal disorders, which affects nearly half of the general population. Treatment of grade III haemorrhoids consists initially of conservative measures, followed by rubber band ligation and haemorrhoidectomy when unsuccessful. Given the current guidelines and numerous modalities the obvious question which needs to be answered is which treatment is the best for grade III haemorrhoids. There is a need for evaluating treatment from the patient's point of view and transparency in surgical and non-surgical treatment outcome. Methods and analysis This multicentre, randomised controlled, non-inferiority trial with cost-utility analysis compares haemorrhoidectomy with rubber band ligation. Patients aged 18 years and older with symptomatic haemorrhoids grade III are recruited. Primary outcome measure is quality of life at 24 months measured with the EQ-5D-5L and in-hospital (in)direct costs and out-of-hospital postoperative costs. A key secondary outcome is recurrence at 1-year postprocedure. Secondary outcomes are complaint reduction with proctology-specific patient-reported outcome measurements (Haemorrhoid Severity Score, ProctoPROM, PROM-HISS, vaizey score), resumption of work, pain and complication rates. Data are collected at seven different time points. Standard postprocedural care is followed. A sample size has been calculated using a one sided alpha of 0.025 and a power of 80% with an SD of 0.15 and a non-inferiority limit of 0.05. With stratification by centre and to adjust for 10% lost to follow-up the total sample size will be 360 patients in total (180 per group). Data will be analysed according to the intention-to-treat and the per-protocol principle. Ethics and dissemination The protocol has been approved by the Medical Ethics Review Committee of the Amsterdam University Medical Centres, location AMC. Findings will be disseminated in peer-reviewed journals and presented at conferences, whether they are positive, negative or inconclusive. Trial registration numbers NCT04621695, NTR8020
AB - Introduction Haemorrhoidal disease is one of the most common anorectal disorders, which affects nearly half of the general population. Treatment of grade III haemorrhoids consists initially of conservative measures, followed by rubber band ligation and haemorrhoidectomy when unsuccessful. Given the current guidelines and numerous modalities the obvious question which needs to be answered is which treatment is the best for grade III haemorrhoids. There is a need for evaluating treatment from the patient's point of view and transparency in surgical and non-surgical treatment outcome. Methods and analysis This multicentre, randomised controlled, non-inferiority trial with cost-utility analysis compares haemorrhoidectomy with rubber band ligation. Patients aged 18 years and older with symptomatic haemorrhoids grade III are recruited. Primary outcome measure is quality of life at 24 months measured with the EQ-5D-5L and in-hospital (in)direct costs and out-of-hospital postoperative costs. A key secondary outcome is recurrence at 1-year postprocedure. Secondary outcomes are complaint reduction with proctology-specific patient-reported outcome measurements (Haemorrhoid Severity Score, ProctoPROM, PROM-HISS, vaizey score), resumption of work, pain and complication rates. Data are collected at seven different time points. Standard postprocedural care is followed. A sample size has been calculated using a one sided alpha of 0.025 and a power of 80% with an SD of 0.15 and a non-inferiority limit of 0.05. With stratification by centre and to adjust for 10% lost to follow-up the total sample size will be 360 patients in total (180 per group). Data will be analysed according to the intention-to-treat and the per-protocol principle. Ethics and dissemination The protocol has been approved by the Medical Ethics Review Committee of the Amsterdam University Medical Centres, location AMC. Findings will be disseminated in peer-reviewed journals and presented at conferences, whether they are positive, negative or inconclusive. Trial registration numbers NCT04621695, NTR8020
KW - adult gastroenterology
KW - colorectal surgery
KW - dermatology
UR - http://www.scopus.com/inward/record.url?scp=85103979718&partnerID=8YFLogxK
U2 - https://doi.org/10.1136/bmjopen-2020-046836
DO - https://doi.org/10.1136/bmjopen-2020-046836
M3 - Article
SN - 2044-6055
VL - 11
JO - BMJ Open
JF - BMJ Open
IS - 4
M1 - e046836
ER -