Patient reported outcome measure-haemorrhoidal impact and satisfaction score (PROM-HISS): Development, reliability and construct validity.

AIM: Haemorrhoidal disease (HD) is a frequently occurring disorder with a significant negative impact on a patient's quality of life. Here, we describe the development and validation of the Dutch patient reported outcome measure-haemorrhoidal impact and satisfaction score (PROM-HISS). METHODS: The development of the PROM-HISS followed recommended guidelines. Face and content validity, structural properties, reliability and construct validity were evaluated in a HD population. Reliability was tested by assessing the test-retest reliability, defined by the intraclass correlation coefficient (ICC), and internal consistency measured with Cronbach's alpha. Construct validity was evaluated using confirmatory factor analysis (CFA) and hypotheses testing. RESULTS: The PROM-HISS consists of three domains: (1) HD symptoms (blood loss; pain; prolapse; soiling; itching), (2) impact of symptoms on daily activities, and (3) satisfaction with treatment. The PROM-HISS showed good face and content validity. The PROM-HISS was completed by 102 patients (65% male), with a mean age of 58 years (23-81 years). The ICCs of the different items in the domain HD symptoms ranged between 0.56 and 0.79 and were interpreted as good. The Cronbach's alpha value was 0.80 and considered satisfactory. The CFA provided further evidence for construct validity with a good model fit. A high score on the symptoms of HD correlated with a high impact of HD on daily activities (Pearson's r = 0.632, p < 0.01) and a low degree of satisfaction (Pearson's r = 0.378, p < 0.01). CONCLUSION: The PROM-HISS is a reliable and valid instrument to evaluate symptoms of HD, impact on daily activities and satisfaction with treatment.

A national evaluation of the management practices of hemorrhoidal disease in the Netherlands.

PURPOSE: In this study, we describe current practices in the management of hemorrhoidal disease in the Netherlands. METHODS: A validated online survey was performed among Dutch surgeons and residents treating hemorrhoidal disease. Contact details were retrieved from the Dutch Association for Surgery resulting in 619 contacts. Only doctors who were treating hemorrhoidal disease regularly were asked to complete the questionnaire. The following items were assessed: initial treatment, recurrence, complications, and follow-up. RESULTS: In total, 133 respondents completed the survey. Ninety percent of the respondents started with rubber band ligation (RBL) as the first treatment in low-grade hemorrhoidal disease. In case of recurrence, 64% of the respondents repeated RBL three times before switching to a more invasive treatment modality. In grade III hemorrhoidal disease, the respondents preferred more invasive techniques: a sutured hemorrhoidopexy was performed in 24%, Doppler-guided hemorrhoidal artery ligation (DG-HAL) in 9%, stapled hemorrhoidopexy in 19%, and the traditional hemorrhoidectomy in 31% of the patients, respectively. The majority of the respondents (39%) reported a mild complication in 5-10% of the patients. The most reported complication was pain. Nearly all the respondents (98%) reported a major complication in less than 5% of the patients. The majority of the patients (57%) were seen in outpatient clinics 6 weeks post-treatment. CONCLUSION: This Dutch survey showed areas of common practice for primary treatment of hemorrhoidal disease. However, it also demonstrated varying practices regarding recurrent hemorrhoidal disease. Practical guidelines are required to support colorectal surgeons in the Netherlands.

Effectiveness and cost-effectiveness of rubber band ligation versus sutured mucopexy versus haemorrhoidectomy in patients with recurrent haemorrhoidal disease (Napoleon trial): Study protocol for a multicentre randomized controlled trial.

BACKGROUND: Currently, there is no consensus regarding the best treatment option in recurrent haemorrhoidal disease (HD), due to a lack of solid evidence. The Napoleon trial aims to provide high-level evidence on the comparative effectiveness and cost-effectiveness of repeat rubber band ligation (RBL) versus sutured mucopexy versus haemorrhoidectomy in patients with recurrent HD. METHODS: This is a multicentre randomized controlled trial. Patients with recurrent HD grade II and III, ≥18 years of age and who had at least two RBL treatments in the last three years are eligible for inclusion. Exclusion criteria include previous rectal or anal surgery, rectal radiation, pre-existing sphincter injury or otherwise pathologies of the colon and rectum, pregnancy, presence of hypercoagulability disorders, and medically unfit for surgery (ASA > III). Between June 2020 and May 2022, 558 patients will be randomized to receive either: (1) RBL, (2) sutured mucopexy, or (3) haemorrhoidectomy. The primary outcomes are recurrence after 52 weeks and patient-reported symptoms measured by the PROM-HISS. Secondary outcomes are impact on daily life, treatment satisfaction, early and late complication rates, health-related quality of life, costs and cost-effectiveness, and budget impact. Cost-effectiveness will be expressed in societal costs per Quality Adjusted Life Year (QALY) (based on EQ-5D-5L), and healthcare costs per recurrence avoided. DISCUSSION: The best treatment option for recurrent HD remains unknown. The comparison of three generally accepted treatment strategies in a randomized controlled trial will provide high-level evidence on the most (cost-) effective treatment. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT04101773.