Responsiveness of the Patient-Reported Outcome Measure-Haemorrhoidal Impact and Satisfaction Score in patients with haemorrhoidal disease.

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.

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.

Yield of Screening for COVID-19 in Asymptomatic Patients Before Elective or Emergency Surgery Using Chest CT and RT-PCR (SCOUT): Multicenter Study.

OBJECTIVE: To determine the yield of preoperative screening for COVID-19 with chest CT and RT-PCR in patients without COVID-19 symptoms. SUMMARY OF BACKGROUND DATA: Many centers are currently screening surgical patients for COVID-19 using either chest CT, RT-PCR or both, due to the risk for worsened surgical outcomes and nosocomial spread. The optimal design and yield of such a strategy are currently unknown. METHODS: This multicenter study included consecutive adult patients without COVID-19 symptoms who underwent preoperative screening using chest CT and RT-PCR before elective or emergency surgery under general anesthesia. RESULTS: A total of 2093 patients without COVID-19 symptoms were included in 14 participating centers; 1224 were screened by CT and RT-PCR and 869 by chest CT only. The positive yield of screening using a combination of chest CT and RT-PCR was 1.5% [95% confidence interval (CI): 0.8-2.1]. Individual yields were 0.7% (95% CI: 0.2-1.1) for chest CT and 1.1% (95% CI: 0.6-1.7) for RT-PCR; the incremental yield of chest CT was 0.4%. In relation to COVID-19 community prevalence, up to ∼6% positive RT-PCR was found for a daily hospital admission rate >1.5 per 100,000 inhabitants, and around 1.0% for lower prevalence. CONCLUSIONS: One in every 100 patients without COVID-19 symptoms tested positive for SARS-CoV-2 with RT-PCR; this yield increased in conjunction with community prevalence. The added value of chest CT was limited. Preoperative screening allowed us to take adequate precautions for SARS-CoV-2 positive patients in a surgical population, whereas negative patients needed only routine procedures.

Picking Up the Threads: Long-Term Outcomes of the Sutured Haemorrhoidopexy: A Retrospective Single-Centre Cohort Study.

BACKGROUND: This study aimed to assess the short- and long-term safety and efficacy of the sutured haemorrhoidopexy (SH) in patients with haemorrhoidal disease (HD). METHODS: A retrospective study was performed, assessing the following treatment characteristics: number of sutures needed; operation time; perioperative complications; postoperative pain; hospital stay. The short- and long-term postoperative complications, HD recurrence and data on current HD symptoms were assessed according to the Core Outcome Set for HD. RESULTS: Between January 2009 and December 2021, 149 patients with HD underwent a SH. One-hundred and forty-five patients were included, with a mean age of 61 years (±12.8), of which 70 were women (48.3%). Patients were predominantly diagnosed with grade III (37.2%) HD and the median follow-up was nine years (5-11). Perioperative complications occurred in four cases (2.8%). In two patients (1.4%), short-term postoperative complications were reported, and in seven patients (6.2%), long-term complications were reported. The cumulative efficacy in terms of freedom of recurrence was 88.3% (95% CI, 83.1-93.5) at six months, 80.0% (95% CI, 73.5-86.5) at one year, and 67.7% (95% CI, 59.7-75.7) at five years. CONCLUSIONS: Sutured haemorrhoidopexy is a safe treatment for patients with HD and can be proposed as a minimally invasive surgical treatment if basic and outpatient procedures fail.

Making Use of Patient-Reported Outcome Measures for Haemorrhoidal Disease in Clinical Practice: A Perspective.

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.

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.

Fecal incontinence treated by sacral neuromodulation: Long-term follow-up of 325 patients.

BACKGROUND: Long-term results of large patient cohorts with fecal incontinence treated by sacral neuromodulation are limited. This study shows the long-term results after a mean follow-up of 7.1 years in 325 patients with fecal incontinence treated by continuous sacral neuromodulation. METHODS: All patients with fecal incontinence and eligible for sacral neuromodulation between 2000 and 2015 were evaluated retrospectively. Primary outcome was a decrease in episodes of fecal incontinence, which was defined as involuntary fecal loss at least once per week and documented by a 3 week bowel habit diary. Quality of life was assessed using the Short-Form 36 and the Fecal Incontinence Quality of Life Score. RESULTS: In the study, 374 patients were included for sacral neuromodulation screening and 325 patients (32 male, 9.7%) received permanent, continuous sacral neuromodulation. Mean age was 56.5 years (17-82 years) and mean follow-up was 7.1 years (3.0-183.4 months). In the 325 patients with permanent sacral neuromodulation, fecal incontinence episodes decreased from a mean of 16.1 ± 14.5 to 3.0 ± 3.7 per 3-week period after sacral neuromodulation (P < .001) according to the bowel habit diary. Sacral neuromodulation was removed due to unsatisfactory results in 81 patients. Quality of life (both Short-Form 36 and Fecal Incontinence Quality of Life Score) showed no significant difference compared with the Dutch population during follow-up. CONCLUSION: Long-term efficacy of sacral neuromodulation can be maintained in about half (52.7%) of all patients screened with sacral neuromodulation for fecal incontinence after a mean follow-up of 7.1 years. Importantly, the quality of life of patients with sacral neuromodulation for fecal incontinence did not differ from the general population.

A morphometric analysis of pathological alterations in hemorrhoidal disease versus normal controls: a controlled trial

Objective: Until today, the true pathophysiology of hemorrhoidal disease (HD) has not yet been unraveled. More and more evidence guides us towards the hypothesis that reduced connective tissue stability is associated with a higher incidence of hemorrhoids. The present study aimed to compare the quantity and quality of collagen, and vessel morphometrics, in patients with symptomatic HD compared with normal controls. Methods: Twenty-two samples of grade III and grade IV HD tissue from patients undergoing a hemorrhoidectomy between January 2004 and June 2015 were included in the study group. Samples of 15 individuals without symptomatic HD who donated their body to science and died a natural death served as controls. The quantity and quality of anal collagen, and anal vessel morphometrics were objectified. The quality of collagen was subdivided in young (immature) and old (mature) collagen. Results: Patients with HD had an increased percentage of total anal collagen (62.1 ± 13.8 versus 18.7 ± 14.5%; p = 0.0001), a decreased percentage of young collagen (0.00009 ± 0.00008 versus 0.0008 ± 0.0008%; p = 0.001), and a smaller surface area of the anal vessels (795.1 ± 1215.9 micrometre2 versus 1219.0 ± 1976.1; p = 0.003) compared with controls. The percentage of old collagen did not differ between the control and study groups (0.588 ± 0.286% versus 0.389 ± 0.242%; p = 0.06). Conclusion: The outcomes of the present study suggest that alterations in anal collagen composition may play a role in the formation of hemorrhoids. (AU)

Experiences of patients with haemorrhoidal disease - a qualitative study / Experiências de pacientes com doença hemorroidária - estudo qualitativo

ABSTRACT Purpose: To obtain a better understanding of the patients' experiences with haemorrhoidal disease' impact on their daily life and results of treatment by performing a qualitative study. Method: Individually interviews were conducted among patients with haemorrhoidal disease between 2016 and 2017. Each interview was recorded using an audio recorder and transcribed verbatim. A semi-structured interview guide was used with pre-specified topics, based on a previous conducted literature review. Transcripts were coded and the analysis consisted highlighting passages in the text and assigning each passage a code representing the predefined themes from the interview guide. This resulted in a three-level theme hierarchy: overarching theme, mid-level sub-theme and issues. Results: Fifteen participants underwent individual interviews of whom thirteen were conducted by telephone. The mean age was 60.7 years (35-78); five of them were female (33.3%). Pain and blood loss were the most frequently reported symptoms. Participants indicated that these symptoms were directly associated with emotional burden, daily adjustments and social impact. Before diagnosis with haemorrhoidal disease blood loss resulted in feelings of fear and next in embarrassment during social activities. In daily life participants needed to get up early, used sanitary pads for blood loss and anal ice sticks to reduce pain. Participants were often not completely satisfied with the process and outcome of treatment. Conclusion: This first qualitative study provides detailed insight into the patients' experiences with haemorrhoidal disease, impact on daily life and results of treatment. This information may be used in daily practice to create awareness among clinicians.

RESUMO Objetivo: Este estudo qualitativo teve como objetivo propiciar uma melhor compreensão das experiências dos pacientes com doença hemorroidária, o impacto em sua vida diária e os resultados do tratamento. Métodos: Entre 2016 e 2017, pacientes com doença hemorroidária foram entrevistados individualmente. Cada entrevista foi gravada usando um gravador de áudio e transcrita na íntegra. Utilizou-se guia de entrevista semiestruturado, com tópicos pré-especificados baseados em uma revisão de literatura realizada anteriormente. As transcrições foram codificadas; a análise consistiu em destacar passagens no texto e atribuir a cada passagem um código representando os temas predefinidos no guia de entrevista. Isso resultou em uma hierarquia de temas de três níveis: tema abrangente, subtema de nível médio e problemas. Resultados: Quinze participantes foram submetidos a entrevistas individuais, das quais treze foram conduzidas por telefone. A média de idade foi de 60,7 anos (35-78); cinco deles eram do sexo feminino (33,3%). Dor e hemorragia foram os sintomas mais frequentemente relatados. Os participantes indicaram que esses sintomas estavam diretamente relacionados a sobrecarga emocional, ajustes nas atividades diárias e impacto social. Antes do diagnóstico de doença hemorroidária, a hemorragia levou a sentimentos de medo e de constrangimento durante as atividades sociais. No dia-a-dia, os participantes precisavam acordar cedo, usar absorventes higiênicos para perda de sangue e gelo na região anal para reduzir a dor. Geralmente, os participantes não estavam completamente satisfeitos com o processo e o resultado do tratamento. Conclusão: Este primeiro estudo qualitativo apresenta uma visão detalhada das experiências dos pacientes com doença hemorroidária, o impacto na vida diária e resultados do tratamento. Essas informações podem ser usadas na prática diária para conscientizar os médicos.