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.

Background: The diverse range of therapeutic options for hemorrhoidal disease (HD) highlights the need for precise classification systems to guide treatment. Although the Goligher classification remains the most widely used, it has been criticized for its simplicity and limited ability to capture symptom severity or guide treatment decisions. This study aims to evaluate the patient selection criteria and classification systems employed in randomized controlled trials (RCTs) for HD. Methods: A systematic review was conducted following the 2020 PRISMA guidelines. A comprehensive search of databases identified randomized controlled trials (RCTs) comparing treatments for HD, focusing on classification systems used for patient enrollment. Eligible studies included adult patients and at least one arm involving surgical treatment. Results: Out of 6692 records, 162 studies met the inclusion criteria, with a median cohort size of 84 patients and 55.4% male. Most studies (86.4%) used the Goligher system, though the majority did not fully describe or cite the system. Only 13.6% of studies employed more recent alternative classification systems. The most common outcome measures across studies were postoperative pain (147 studies) and complications (133 studies). Recurrence rates were reported in 42% of studies, yet 70% of these did not provide adequate inclusion criteria or references to Goligher’s classification. Conclusions: The inconsistent application of the Goligher classification and the variability in patient selection criteria across RCTs highlight the need for more nuanced and standardized systems. Future research should focus on refining classification methods and incorporating patient-reported outcomes to improve the reliability and relevance of HD trials. PROSPERO registration: CRD42023387339.

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. 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. 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. ClinicalTrials.gov identifier: NCT04101773.

Haemorrhoidal disease (HD) affects millions of people around the world and for most it is a recurring problem. Increasingly, clinicians broaden their focus on the patient's experiences with haemorrhoidal symptoms, including their impact on daily life. The patient's experience can be assessed using a patient-reported outcome measure (PROM). A PROM facilitates a deeper understanding of the disease-burden and allows a clinician to obtain information directly from the patients about their experiences with the ailment. Over the last years, PROMs have shown their additional role to traditional outcomes for several diseases and have earned their place in the daily consultation room. In order to improve and personalize the treatment of HD, we endorse the use of validated PROMs in clinical care.

Aim: In this study we aimed to assess the responsiveness of the symptom score of the recently developed Patient‐Reported Outcome Measure‐Haemorrhoidal Impact and Satisfaction Score (PROM‐HISS). Furthermore, the minimally relevant difference (MRD) was determined.Method: The responsiveness of PROM‐HISS was tested using a criterion‐based (i.e. anchor) and construct‐based (i.e. hypotheses testing) approach. Patients with haemorrhoidal disease (HD) completed the PROM‐HISS before and 1 week after treatment in hospital. A global self‐assessment of change question (SCQ) was administered 1‐week after treatment and functioned as the criterion. The following analyses were performed: (1) correlation between the PROM‐HISS symptom score and the criterion (SCQ) and (2) hypotheses testing. The MRD was determined as change in symptoms of the subgroup reporting ‘somewhat fewer complaints’ on the SCQ.Results: Between February and August 2022, 94 patients with grade II–IV HD from three hospitals were included. The correlation between the SCQ and a change on the PROM‐HISS symptom score was 0.595 indicating that an improvement on the SCQ corresponds to an improvement on the PROM‐HISS symptom score. As hypothesized, the mean change in PROM‐HISS scores was significantly different between subgroups of patients based on their SCQ responses. Patients reporting a small change in HD symptoms on the SCQ corresponded to a mean change of 0.3 on the PROM‐HISS symptom score.Conclusion: The PROM‐HISS symptom score is a responsive instrument as it identifies change in HD symptoms because of treatment. The estimated MRD of 0.3 can be used to inform clinical research and practice.