Impact of Ambulatory Surgery for Hemorrhoidal Disease on Clinical Outcomes and Institutional Costs / Impacto da cirurgia ambulatória para patologia hemorroidária nos resultados clínicos e custos

Abstract Objective Transanal hemorrhoidal artery ligation with mucopexy (ligation anopexy [LA]) and open hemorrhoidectomy (OH) can both be performed under local anesthesia. The aim of the present study was to analyze the impact and the cost-effectiveness of performing these techniques in an ambulatory setting of an Italian academic center on the postoperative outcome. Methods A series of 122 consecutive patients with grades II and III hemorrhoidal disease undergoing ambulatory surgical treatment of hemorrhoids in 2015 to 2018 (group A) was comparedwith 122 patients operated at the same institution in the same period (group H) in a hospital setting. The primary outcome was the number of days required to return to work/daily activities. Secondary outcomes included postoperative pain and complications, costeffectiveness, patient satisfaction, and recurrence at 12 months. In group A, all the procedures were performed under local anesthesia with early discharge. In group H, the procedureswere performed under general or loco-regional anesthesia with hospital admission. Results The mean number of days required to return to work/daily activities was 8.4 ± 4.8 days in group A, compared with 12.5 ± 3 days in group H (p<0.001). The visual analog scale (VAS) pain score at 1 week, 2 and 3 weeks, and 1 month after surgery was lower for patients undergoing LA in the ambulatory setting (p<0.01). We observedmore postoperative complications in hospitalized (12.5%) than in ambulatory patients (7.5%) (p<0.001). The total mean direct costs per patient were significantly lower in the ambulatory setting versus the hospital stay group (351.3 versus 1,746 euros). Conclusion Implementing ambulatory surgery for hemorrhoids is feasible, safe, and cost-effective.

Resumo Objetivo A ligação transanal da artéria hemorroidária com mucopexia e a hemorroidectomia aberta (HA) podem ser realizadas em anestesia local. O objetivo do presente estudo foi analisar o impacto no resultado pós-operatório e a relação custo-eficácia da realização destas técnicas em ambiente ambulatorial de um centro acadêmico italiano no desfecho pós-operatório. Métodos Uma série de 122 pacientes consecutivos com patologia hemorroidária de graus II e III submetidos a cirurgia de hemorroidas em regime ambulatório de 2015 a 2018 (grupo A) foi comparada com 122 pacientes operados na mesma instituição no mesmo período (grupo H) por hospitalização. O desfecho primário foi o número de dias necessários para regressar ao trabalho/atividades diárias. Os desfechos secundários incluíram dor e complicações pós-operatórias, custo-eficácia, satisfação do paciente, e recidiva aos 12 meses. No grupo A, todos os procedimentos foram realizados em anestesia local. No grupo H, os procedimentos foram realizados em anestesia geral ou loco-regional. Resultados A espera média para o regresso ao trabalho foi de 8,4 ± 4,8 dias no grupo A em comparação com 12,5 ± 3 dias no grupo H (p<0,001). A pontuação na escala visual analógica (EVA) da dor 1 semana, 2 e 3 semanas, e 1 mês após a cirurgia foi mais baixa para os pacientes submetidos a cirurgia de ligadura com anopexia em ambiente ambulatorial (p<0,01). Observamosmais complicações pós-operatórias empacientes hospitalizados (12,5%) do que em pacientes ambulatórios (7,5%) (p<0,001). Os custos diretosmédios totais por paciente foram mais baixos em ambiente ambulatório do que no grupo de hospitalização (351,3 contra 1.746 euros). Conclusão A implementação da cirurgia ambulatória para hemorroidas é possível, segura e rentável.

[Analysis on clinical efficacy, safety and economy of Shaobei injection and elastic band ligation in the treatment of grade II or III hemorrhoids].

Objective: Currently, various treatments such as hemorrhoidectomy, ligation and sclerotherapy injection can be applied in grade II or III hemorrhoids. This study aims to compare the clinical efficacy, safety and economy between Shaobei injection and elastic band ligation in treating patients with grade II or grade III hemorrhoids. Methods: A retrospective cohort study was used. Clinical data of 60 patients with grade II or grade III hemorrhoids at Department of Anorectal Surgery of the Sixth Affiliated Hospital, Sun Yat-sen University between January 2019 and October 2019 were collected. Patients were divided into two groups according to surgical methods. Patients in the Shaobei group received Shaobei injection (n=28), and those in the ligation group received elastic band ligation (n=32). Inclusion criteria: (1) diagnosis of grade II or III hemorrhoid; (2) application of Shaobei injection or elastic band ligation; (3) age between 18-75 years old. Exclusion criteria: (1) comorbidity with anal fissure, anal fistula, anal sinusitis or other perianal diseases; (2) patients with mental disorder or poor compliance; (3) incomplete clinical or follow-up data. Recurrent rate, postoperative pain, anal edema, anal distension, total cost of hospitalization, length of hospitalization, and postoperative life quality EQ-5D-3L score were compared between the two groups at postoperative 6-month. Results: No significant difference was observed in the baseline data (including Nystrom hemorrhoid symptom score) between the two groups (all P>0.05), except gender ratio [male proportion: Shaobei 75% (21/28) vs. ligation 37.5%(12/32), χ(2)=8.485, P=0.004]. No significant difference in recurrent rate was found between the two groups [14.3% (4/28) vs. 9.4% (3/32), χ(2)=0.035, P=0.851]. Compared to the ligation group, Shaobei group showed less pain at postoperative day 1 [VAS median (range): 2 (1-6) vs. 3 (1-7), Z=2.814, P=0.005] and postoperative day 7 [VAS median (range): 0 (0-2) vs. 1 (0-4), Z=3.149, P=0.002]; lower anal edema ratio at postoperative day 1 [10.7% (3/28) vs. 34.4% (11/32), Z=4.673, P=0.037]; lower anal distension ratio at postoperative day 1 [7.1% (2/28) vs. 28.1% (9/32), Z=4.391, P=0.048]; less hospitalization cost [(6343.5±1444.1) yuan vs. (10 587.1± 1719.0) yuan, t=12.515, P<0.001] and shorter postoperative hospital stay [median (range): 1 (1-5) days vs. 3 (1-6) days, Z=5.879, P<0.001]. The EQ-5D-3L scores of two groups were significantly improved six months after treatment [Shaobei group: (0.90±0.16) vs. (0.73±0.14); ligation group: (0.91±0.13) vs. (0.74±0.10); both P<0.001], while there was no statistically significant difference between the two groups (t=0.130, P=0.897). No complications such as massive hemorrhage, infection, iatrogenic anal fistula, rectal stricture and local induration occurred after the injection. Conclusions: Shaobei injection is effective and safe in treating grade II or III hemorrhoids. Compared with elastic band ligation, it can reduce morbidity of complications and hospitalization expenses.

Hemorrhoid Banding: A Cost-Effectiveness Analysis.

BACKGROUND: Hemorrhoid banding is an established treatment for symptomatic internal hemorrhoids with proven efficacy, low cost, and limited discomfort. Although the costs and quality of life following individual banding treatments have been investigated, little is known about cumulative cost and quality of life from sequential banding therapy or how these cumulative costs compare to surgical therapy. OBJECTIVE: This study aimed to determine the cost-effectiveness of sequential hemorrhoid banding therapy. DESIGN: A retrospective review of historic banding treatment patterns was performed. Cost estimates and quality-of-life predictions were applied to observed treatment patterns in a decision-analytic cost-effectiveness model to compare sequential banding therapy with hypothetical surgical intervention. SETTING: A retrospective billing record review for patients treated in a colorectal specialty clinic between 2012 and 2017 was performed. PATIENTS: Patients initially treated with banding therapy for symptomatic internal hemorrhoids were included. MAIN OUTCOME MEASURE: The primary outcomes measured were hemorrhoid banding treatment patterns, cost-effectiveness, and net monetary benefit. RESULTS: Treatment of 2026 patients undergoing hemorrhoid banding identified 94% resolution with sequential banding and 6% requiring delayed surgical intervention. Average cumulative estimated cost for banding therapy was $723 (range, $382-$4430) per patient with an average quality-of-life deficit of -0.00234 (range, -0.00064 to -0.02638) quality-adjusted life-years. Estimates for hypothetical hemorrhoid artery ligation, stapled hemorrhoidopexy, or surgical hemorrhoidectomy found significantly higher cost (3.15×, 4.39×, and 2.75× more expensive) and a significantly worse quality-of-life deficit (1.55×, 5.64×, and 9.45× worse). For patients with persistent disease, continued sequential banding remained the dominant cost-effective therapy. LIMITATIONS: This cost-effectiveness model relies on a retrospective review of billing records with estimated cost and quality of life. CONCLUSIONS: Hemorrhoid banding is a valuable treatment modality with favorable cost-effectiveness. The majority of patients selected for banding find resolution without surgery. For patients with persistent disease, further banding procedures remain cost-effective compared with delayed surgical therapy. See Video Abstract at http://links.lww.com/DCR/A982. BANDA HEMORROIDAL: UN ANÁLISIS DE COSTO-EFECTIVIDAD: La banda para hemorroides es un tratamiento establecido para las hemorroides internas sintomáticas con eficacia comprobada, bajo costo y malestar limitado. Si bien se han investigado los costos y la calidad de vida después de los tratamientos de bandas individuales, se sabe poco sobre el costo acumulativo y la calidad de vida de la terapia de bandas secuencial o cómo estos costos acumulativos se comparan con la terapia quirúrgica. OBJETIVO: Determinar el costo-efectividad de la terapia secuencial de bandas hemorroidales. DISEÑO:: Se realizó una revisión retrospectiva de la historia de los patrones de tratamiento con bandas. Las estimaciones de costos y las predicciones de la calidad de vida se aplicaron a los patrones de tratamiento observados en un modelo analítico de costo-efectividad para comparar la terapia de bandas secuencial con la intervención quirúrgica hipotética. AJUSTE: Revisión retrospectiva de los registros de facturación de los pacientes tratados en una clínica de especialidad colorrectal entre 2012 y 2017. PACIENTES: Pacientes tratados inicialmente con terapia de bandas para hemorroides internas sintomáticas. PRINCIPALES MEDIDAS DE RESULTADO: Patrones de tratamiento con bandas de hemorroides, costo-efectividad y beneficio monetario neto. RESULTADOS: El tratamiento de 2026 pacientes con bandas identificó una resolución del 94% con bandas secuenciales y el 6% requirió una intervención quirúrgica tardía. El costo promedio acumulado estimado para la terapia de banda fue de $ 723 (Rango: $382-$4430) por paciente con un déficit de calidad de vida promedio de -0.00234 (Rango: -0.00064 a -0.02638) años de vida ajustados por calidad. Las estimaciones para la hipotética ligadura de la arteria hemorroidal, la hemorroidopexia con grapas o la hemorroidectomía quirúrgica encontraron un costo significativamente mayor (3.15×, 4.39×, 2.75× más caro) y un déficit de la calidad de vida significativamente peor (1.55×, 5.64×, 9.45× peor). Para los pacientes con enfermedad persistente, la colocación de bandas secuenciales continuas siguió siendo la terapia rentable dominante. LIMITACIONES: Este modelo de costo-efectividad se basa en una revisión retrospectiva de los registros de facturación con el costo y la calidad de vida estimados. CONCLUSIONES: Las bandas de hemorroides son una valiosa modalidad de tratamiento con una favorable relación costo-efectividad. La mayoría de los pacientes seleccionados para terapia con bandas encuentran resolución sin cirugía. Para los pacientes con enfermedad persistente, los procedimientos de colocación de bandas adicionales siguen siendo rentables en comparación con el tratamiento quirúrgico tardío. Vea el Resumen del video en http://links.lww.com/DCR/A982.

Burden and Cost of Outpatient Hemorrhoids in the United States Employer-Insured Population, 2014.

INTRODUCTION: Although hemorrhoids are a common indication for seeking health care, there are no contemporary estimates of burden and cost. We examined data from an administrative claims database to estimate health care use and aggregate costs. METHODS: We conducted a cross-sectional study using the MarketScan Commercial Claims and Encounters Database for 2014. The analysis included 18.9 million individuals who were aged 18-64 and continuously enrolled with prescription coverage. Outpatient hemorrhoid claims were captured using the International Classification of Diseases, Ninth Revision, Clinical Modification diagnosis codes in the first position, as well as Common Procedural Terminology codes. Prescription medications were identified using National Drug Codes. Annual prevalence and costs were determined by summing gross payments for prescription medications, physician encounters, and facility costs. We used validated weights to standardize annual cost estimates to the US employer-insured population. RESULTS: In 2014, we identified 227,638 individuals with at least one outpatient hemorrhoid-related claim (annual prevalence, 1.2%). Among those, 119,120 had prescription medication claims, 136,125 had physician claims, and 28,663 had facility claims. After standardizing, we estimated that 1.4 million individuals in the US employer-insured population sought care for hemorrhoids in 2014 for a total annual cost of $770 million. This included $322 million in physician claims, $361 million in outpatient facility claims, and $88 million in prescription medication claims. CONCLUSIONS: The estimated economic burden of hemorrhoids in the employer-insured population approaches $800 million annually. Given the substantial and rising burden and cost, expanded research attention should be directed to hemorrhoidal etiology, prevention, and treatment.

A pragmatic multicentre randomised controlled trial comparing stapled haemorrhoidopexy with traditional excisional surgery for haemorrhoidal disease: the eTHoS study.

BACKGROUND: Haemorrhoids are a benign anorectal condition and are highly prevalent in the UK population. Treatments involve clinic-based procedures and surgery. The surgical procedures available include stapled haemorrhoidopexy (SH) and traditional haemorrhoidectomy (TH), and over 25,000 operations are performed for haemorrhoids annually in the UK. The disease is therefore important both to patients and to health service commissioners. Debate remains as to which of these surgical procedures is the most clinically effective and cost-effective. OBJECTIVE: The aim of this study was to compare the clinical effectiveness and cost-effectiveness of SH with that of TH. DESIGN: A large, open two-arm parallel-group pragmatic multicentre randomised controlled trial involving 32 UK hospitals and a within-trial cost-benefit analysis. A discrete choice experiment was conducted to estimate benefits (willingness to pay). PARTICIPANTS: Patients with grades II-IV haemorrhoids who had not previously undergone SH or TH were included in the study. INTERVENTIONS: Participants were randomised to receive either SH or TH. Randomisation was minimised at 1 : 1, in accordance with baseline EuroQol-5 Dimensions, three-level version (EQ-5D-3L) score, haemorrhoid grade, sex and centre, via an automated system. MAIN OUTCOME MEASURES: The primary outcome was area under the quality-of-life curve measured using the EQ-5D-3L descriptive system over 24 months, and the primary economic outcome was the incremental cost-effectiveness ratio. Secondary outcomes included disease-specific quality of life, recurrence, complications, further interventions and costs. RESULTS: Between January 2011 and August 2014, 777 patients were randomised (389 to receive SH and 388 to receive TH). There were 774 participants included in the analysis as a result of one post-randomisation exclusion in the SH arm and two in the TH arm. SH was less painful than TH in the short term. Surgical complications were similar in both arms. EQ-5D-3L score was higher for the SH arm in the first 6 weeks after surgery, but over 24 months the TH group had significantly better EQ-5D-3L scores (-0.073, 95% confidence interval -0.140 to -0.006; p = 0.0342). Symptoms and further interventions were significantly fewer in the TH arm at 24 months. Continence was better in the TH arm and tenesmus occurred less frequently. The number of serious adverse events reported was 24 out of 337 (7.1%) for participants who received SH and 33 out of 352 (9.4%) for those who received TH. There were two deaths in the SH arm, both unrelated to the eTHoS (either Traditional Haemorrhoidectomy or Stapled haemorrhoidopexy for haemorrhoidal disease) study. Patient preference did not seem to influence the treatment difference. SH was dominated by TH as it cost more and was less effective. The net benefit for the TH arm was higher than that for the SH arm. LIMITATIONS: Neither the participants nor the assessors were masked to treatment assignment and final recruitment was slightly short of the total target of 800. There were also substantial missing follow-up data. CONCLUSIONS: While patients who received SH had less short-term pain, after 6 weeks, recurrence rates, symptoms, re-interventions and quality-of-life measures all favoured TH. In addition, TH is cheaper. As part of a tailored management plan for haemorrhoids, TH should be considered over SH as the surgical treatment of choice for haemorrhoids refractory to clinic-based interventions. FUTURE WORK: Perform an updated meta-analysis incorporating recently conducted European trials [eTHoS, HubBLe (haemorrhoidal artery ligation versus rubber band ligation for the management of symptomatic second-degree and third-degree haemorrhoids) and LingaLongo (Cost-effectiveness of New Surgical Treatments for Haemorrhoidal Disease)]. TRIAL REGISTRATION: Current Controlled Trials ISRCTN80061723. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 21, No. 70. See the NIHR Journals Library website for further project information.

Comparison of stapled haemorrhoidopexy with traditional excisional surgery for haemorrhoidal disease (eTHoS): a pragmatic, multicentre, randomised controlled trial.

BACKGROUND: Two commonly performed surgical interventions are available for severe (grade II-IV) haemorrhoids; traditional excisional surgery and stapled haemorrhoidopexy. Uncertainty exists as to which is most effective. The eTHoS trial was designed to establish the clinical effectiveness and cost-effectiveness of stapled haemorrhoidopexy compared with traditional excisional surgery. METHODS: The eTHoS trial was a large, open-label, multicentre, parallel-group, pragmatic randomised controlled trial done in adult participants (aged 18 years or older) referred to hospital for surgical treatment for grade II-IV haemorrhoids. Participants were randomly assigned (1:1) to receive either traditional excisional surgery or stapled haemorrhoidopexy. Randomisation was minimised according to baseline EuroQol 5 dimensions 3 level score (EQ-5D-3L), haemorrhoid grade, sex, and centre with an automated system to stapled haemorrhoidopexy or traditional excisional surgery. The primary outcome was area under the quality of life curve (AUC) measured with the EQ-5D-3L descriptive system over 24 months, assessed according to the randomised groups. The primary outcome measure was analysed using linear regression with adjustment for the minimisation variables. This trial is registered with the ISRCTN registry, number ISRCTN80061723. FINDINGS: Between Jan 13, 2011, and Aug 1, 2014, 777 patients were randomised (389 to receive stapled haemorrhoidopexy and 388 to receive traditional excisional surgery). Stapled haemorrhoidopexy was less painful than traditional excisional surgery in the short term and surgical complication rates were similar between groups. The EQ-5D-3L AUC score was higher in the traditional excisional surgery group than the stapled haemorrhoidopexy group over 24 months; mean difference -0·073 (95% CI -0·140 to -0·006; p=0·0342). EQ-5D-3L was higher for stapled haemorrhoidopexy in the first 6 weeks after surgery, the traditional excisional surgery group had significantly better quality of life scores than the stapled haemorrhoidopexy group. 24 (7%) of 338 participants who received stapled haemorrhoidopexy and 33 (9%) of 352 participants who received traditional excisional surgery had serious adverse events. INTERPRETATION: As part of a tailored management plan for haemorrhoids, traditional excisional surgery should be considered over stapled haemorrhoidopexy as the surgical treatment of choice. FUNDING: National Institute for Health Research Health Technology Assessment programme.

Cost-effectiveness of New Surgical Treatments for Hemorrhoidal Disease: A Multicentre Randomized Controlled Trial Comparing Transanal Doppler-guided Hemorrhoidal Artery Ligation With Mucopexy and Circular Stapled Hemorrhoidopexy.

OBJECTIVE: To compare Doppler-guided hemorrhoidal artery ligation (DGHAL) with circular stapled hemorrhoidopexy (SH) in the treatment of grade II/III hemorrhoidal disease (HD). BACKGROUND: DGHAL is a treatment option for symptomatic HD; existing studies report limited risk and satisfactory outcomes. DGHAL has never before been compared with SH in a large-scale multi-institutional randomized clinical trial. METHODS: Three hundred ninety-three grade II/III HD patients recruited in 22 centers from 2010 to 2013 were randomized to DGHAL (n = 197) or SH (n = 196). The primary endpoint was operative-related morbidity at 3 months (D.90) based on the Clavien-Dindo surgical complications grading. Total cost, cost-effectiveness, and clinical outcome were assessed at 1 year. RESULTS: At D.90, operative-related adverse events occurred after DGHAL and SH, respectively, in 47 (24%) and 50 (26%) patients (P = 0.70). DGHAL resulted in longer mean operating time (44±16 vs 30±14 min; P < 0.001), less pain (postoperative and at 2 wks visual analogic scale: 2.2 vs 2.8; 1.3 vs 1.9; P = 0.03; P = 0.013) and shorter sick leave (12.3 vs 14.8 d; P = 0.045). At 1 year, DGHAL led to more residual grade III HD (15% vs 5%) and a higher reoperation rate (8% vs 4%). Patient satisfaction was >90% for both procedures. Total cost at 1 year was greater for DGHAL [&OV0556;2806 (&OV0556;2670; 2967) vs &OV0556;2538 (&OV0556;2386; 2737)]. The D.90, incremental cost-effectiveness ratio (ICER) was &OV0556;7192 per averted complication. At 1 year DGHAL strategy was dominated. CONCLUSIONS: DGHAL and SH are viable options in grade II/III HD with no significant difference in operative-related risk. Although resulting in less postoperative pain and shorter sick leave, DGHAL was more expensive, took longer, and provided a possible inferior anatomical correction suggesting an increased risk of recurrence.

Haemorrhoidal artery ligation versus rubber band ligation for the management of symptomatic second-degree and third-degree haemorrhoids (HubBLe): a multicentre, open-label, randomised controlled trial.

BACKGROUND: Optimum surgical intervention for low-grade haemorrhoids is unknown. Haemorrhoidal artery ligation (HAL) has been proposed as an efficacious, safe therapy while rubber band ligation (RBL) is a commonly used outpatient treatment. We compared recurrence after HAL versus RBL in patients with grade II-III haemorrhoids. METHODS: This multicentre, open-label, parallel group, randomised controlled trial included patients from 17 acute UK NHS trusts. We screened patients aged 18 years or older presenting with grade II-III haemorrhoids. We excluded patients who had previously received any haemorrhoid surgery, more than one injection treatment for haemorrhoids, or more than one RBL procedure within 3 years before recruitment. Eligible patients were randomly assigned (in a 1:1 ratio) to either RBL or HAL with Doppler. Randomisation was computer-generated and stratified by centre with blocks of random sizes. Allocation concealment was achieved using a web-based system. The study was open-label with no masking of participants, clinicians, or research staff. The primary outcome was recurrence at 1 year, derived from the patient's self-reported assessment in combination with resource use from their general practitioner and hospital records. Recurrence was analysed in patients who had undergone one of the interventions and been followed up for at least 1 year. This study is registered with the ISRCTN registry, ISRCTN41394716. FINDINGS: From Sept 9, 2012, to May 6, 2014, of 969 patients screened, 185 were randomly assigned to the HAL group and 187 to the RBL group. Of these participants, 337 had primary outcome data (176 in the RBL group and 161 in the HAL group). At 1 year post-procedure, 87 (49%) of 176 patients in the RBL group and 48 (30%) of 161 patients in the HAL group had haemorrhoid recurrence (adjusted odds ratio [aOR] 2·23, 95% CI 1·42-3·51; p=0·0005). The main reason for this difference was the number of extra procedures required to achieve improvement (57 [32%] participants in the RBL group and 23 [14%] participants in the HAL group had a subsequent procedure for haemorrhoids). The mean pain 1 day after procedure was 3·4 (SD 2·8) in the RBL group and 4·6 (2·8) in the HAL group (difference -1·2, 95% CI -1·8 to -0·5; p=0·0002); at day 7 the scores were 1·6 (2·3) in the RBL group and 3·1 (2·4) in the HAL group (difference -1·5, -2·0 to -1·0; p<0·0001). Pain scores did not differ between groups at 21 days and 6 weeks. 15 individuals reported serious adverse events requiring hospital admission. One patient in the RBL group had a pre-existing rectal tumour. Of the remaining 14 serious adverse events, 12 (7%) were among participants treated with HAL and two (1%) were in those treated with RBL. Six patients had pain (one treated with RBL, five treated with HAL), three had bleeding not requiring transfusion (one treated with RBL, two treated with HAL), two in the HAL group had urinary retention, two in the HAL group had vasovagal upset, and one in the HAL group had possible sepsis (treated with antibiotics). INTERPRETATION: Although recurrence after HAL was lower than a single RBL, HAL was more painful than RBL. The difference in recurrence was due to the need for repeat bandings in the RBL group. Patients (and health commissioners) might prefer such a course of RBL to the more invasive HAL. FUNDING: NIHR Health Technology Assessment programme.

A pragmatic, multicentre, randomised controlled trial comparing stapled haemorrhoidopexy to traditional excisional surgery for haemorrhoidal disease (eTHoS): study protocol for a randomised controlled trial.

BACKGROUND: Current interventions for haemorrhoidal disease include traditional haemorrhoidectomy (TH) and stapled haemorrhoidopexy (SH) surgery. However, uncertainty remains as to how they compare from a clinical, quality of life (QoL) and economic perspective. The study is therefore designed to determine whether SH is more effective and more cost-effective, compared with TH. METHODS/DESIGN: eTHoS (either Traditional Haemorrhoidectomy or Stapled Haemorrhoidopexy for Haemorrhoidal Disease) is a pragmatic, multicentre, randomised controlled trial. Currently, 29 secondary care centres are open to recruitment. Patients, aged 18 year or older, with circumferential haemorrhoids grade II to IV, are eligible to take part. The primary clinical and economic outcomes are QoL profile (area under the curve derived from the EuroQol Group's 5 Dimension Health Status Questionnaire (EQ-5D) at all assessment points) and incremental cost per quality adjusted life year (QALY) based on the responses to the EQ-5D at 24 months. The secondary outcomes include a comparison of the SF-36 scores, pain and symptoms sub-domains, disease recurrence, complication rates and direct and indirect costs to the National Health Service (NHS). A sample size of n =338 per group has been calculated to provide 90% power to detect a difference in the mean area under the curve (AUC) of 0.25 standard deviations derived from EQ-5D score measurements, with a two-sided significance level of 5%. Allowing for non-response, 400 participants will be randomised per group. Randomisation will utilise a minimisation algorithm that incorporates centre, grade of haemorrhoidal disease, baseline EQ-5D score and gender. Blinding of participants and outcome assessors is not attempted. DISCUSSION: This is one of the largest trials of its kind. In the United Kingdom alone, 29,000 operations for haemorrhoidal disease are done annually. The trial is therefore designed to give robust evidence on which clinicians and health service managers can base management decisions and, more importantly, patients can make informed choices. TRIAL REGISTRATION: Current Controlled Trials ISRCTN80061723 (assigned 8 March 2010).

The HubBLe trial: haemorrhoidal artery ligation (HAL) versus rubber band ligation (RBL) for haemorrhoids.

BACKGROUND: Haemorrhoids (piles) are a very common condition seen in surgical clinics. After exclusion of more sinister causes of haemorrhoidal symptoms (rectal bleeding, perianal irritation and prolapse), the best option for treatment depends upon persistence and severity of the symptoms. Minor symptoms often respond to conservative treatment such as dietary fibre and reassurance. For more severe symptoms treatment such as rubber band ligation may be therapeutic and is a very commonly performed procedure in the surgical outpatient setting. Surgery is usually reserved for those who have more severe symptoms, as well as those who do not respond to non-operative therapy; surgical techniques include haemorrhoidectomy and haemorrhoidopexy. More recently, haemorrhoidal artery ligation has been introduced as a minimally invasive, non destructive surgical option.There are substantial data in the literature concerning efficacy and safety of 'rubber band ligation including multiple comparisons with other interventions, though there are no studies comparing it to haemorrhoidal artery ligation. A recent overview has been carried out by the National Institute for Health and Clinical Excellence which concludes that current evidence shows haemorrhoidal artery ligation to be a safe alternative to haemorrhoidectomy and haemorrhoidopexy though it also highlights the lack of good quality data as evidence for the advantages of the technique. METHODS/DESIGN: The aim of this study is to establish the clinical effectiveness and cost effectiveness of haemorrhoidal artery ligation compared with conventional rubber band ligation in the treatment of people with symptomatic second or third degree (Grade II or Grade III) haemorrhoids. DESIGN: A multi-centre, parallel group randomised controlled trial. OUTCOMES: The primary outcome is patient-reported symptom recurrence twelve months following the intervention. Secondary outcome measures relate to symptoms, complications, health resource use, health related quality of life and cost effectiveness following the intervention. PARTICIPANTS: 350 patients with grade II or grade III haemorrhoids will be recruited in surgical departments in up to 14 NHS hospitals. RANDOMISATION: A multi-centre, parallel group randomised controlled trial. Block randomisation by centre will be used, with 175 participants randomised to each group. DISCUSSION: The results of the research will help inform future practice for the treatment of grade II and III haemorrhoids. TRIAL REGISTRATION: ISRCTN41394716.

Stapled hemorrhoidopexy, an innovative surgical procedure for hemorrhoidal prolapse: cost-utility analysis.

AIM: To undertake full economic evaluation of stapled hemorrhoidopexy (PPH) to establish its cost-effectiveness and investigate whether PPH can become cost-saving compared to conventional excisional hemorrhoidectomy (CH). METHODS: A cost-utility analysis in hospital and health care system (UK) was undertaken using a probabilistic, cohort-based decision tree to compare the use of PPH with CH. Sensitivity analyses allowed showing outcomes in regard to the variations in clinical practice of PPH procedure. The participants were patients undergoing initial surgical treatment of third and fourth degree hemorrhoids within a 1-year time-horizon. Data on clinical effectiveness were obtained from a systematic review of the literature. Main outcome measures were the cost per procedure at the hospital level, total direct costs from the health care system perspective, quality adjusted life years (QALY) gained and incremental cost per QALY gained. RESULTS: A decrease in operating theater time and hospital stay associated with PPH led to a cost saving compared to CH of GBP 27 (US $43.11, €30.50) per procedure at the hospital level and to an incremental cost of GBP 33 (US $52.68, €37.29) after one year from the societal perspective. Calculation of QALYs induced an incremental QALY of 0.0076 and showed an incremental cost-effective ratio (ICER) of GBP 4316 (US $6890.47, €4878.37). Taking into consideration recent literature on clinical outcomes, PPH becomes cost saving compared to CH for the health care system. CONCLUSIONS: PPH is a cost-effective procedure with an ICER of GBP 4136 and it seems that an innovative surgical procedure could be cost saving in routine clinical practice.

Economic evaluation of the treatment of grade II haemorrhoids: a comparison of stapled haemorrhoidopexy and rubber band ligation.

OBJECTIVES: Haemorrhoidal disease is a common condition causing considerable distress to individuals and significant cost to healthcare services. This paper explored the cost-effectiveness of stapled haemorrhoidopexy (SH) compared with the non-surgical intervention, rubber band ligation (RBL), for grade II symptomatic circumferential haemorrhoids. METHOD: An economic evaluation alongside a randomized controlled trial conducted between October 2002 and February 2005. Adults were recruited and randomized to either SH or RBL. The same surgeon performed all procedures and investigators were blinded until analyses were completed. Primary outcomes measured at 52 weeks were cumulative costs to the NHS, clinical diagnosis of recurrence and quality adjusted life years (QALYs). RESULTS: Sixty symptomatic men and women with confirmed clinical diagnosis of grade II symptomatic haemorrhoids were randomized. Loss to follow-up was up to 10% at 52 weeks. The mean cost for SH was greater than RBL (mean difference: 1483 pounds, 95% CI: 1339-1676); disease recurrence was lower (OR = 0.18, 95% CI: 0.03-0.86); and there was no evidence of a statistically significant difference in QALYs (-0.014, 95% CI: -0.076 to 0.051). SH was associated with a modest incremental cost per recurrence avoided at 12 months follow-up (4945 pounds). Based on current data, it was considered highly unlikely to be cost-effective in terms of incremental cost per QALY. CONCLUSIONS: There is insufficient evidence about the cost-effectiveness of SH for grade II haemorrhoids to recommend its routine use in place of RBL. Further information is needed from larger trials with a longer-term follow-up to inform subsequent economic evaluation.

Stapled haemorrhoidectomy (haemorrhoidopexy) for the treatment of haemorrhoids: a systematic review and economic evaluation.

OBJECTIVES: To determine the safety, clinical effectiveness and cost-effectiveness of circular stapled haemorrhoidopexy (SH) for the treatment of haemorrhoids. DATA SOURCES: Main electronic databases were searched up to July 2006. REVIEW METHODS: Randomised controlled trials (RCTs) with 20 or more participants that compared SH with any conventional haemorrhoidectomy (CH) technique in people of any age with prolapsing haemorrhoids for whom surgery is considered a relevant option, were used to evaluate clinical effectiveness. An economic model of the surgical treatment of haemorrhoids was developed. RESULTS: The clinical effectiveness review included 27 RCTs (n = 2279; 1137 SH; 1142 CH). All had some methodological flaws; only two reported recruiting patients with second, third and fourth degree haemorrhoids, and 37% reported using an appropriate method of randomisation and/or allocation concealment. In the early postoperative period 95% of trials reported less pain following SH; by day 21 the pain reported following SH and CH was minimal, with little difference between the two techniques. Significantly fewer patients had unhealed wounds at 6 weeks following SH [odds ratio (OR) 0.08, 95% confidence interval (CI) 0.03 to 0.19, p < 0.001]. Residual prolapse was more common after SH (OR 3.38, 95% CI 1.00 to 11.47, p = 0.05, nine RCTs, results of a sensitivity analysis). There was no difference between SH and CH in the incidence of bleeding or postoperative complications. SH resulted in shorter operating times, hospital stay, time to first bowel movement and return to normal activity. In the short term (between 6 weeks and a year) prolapse was more common after SH (OR 4.68, 95% CI 1.11 to 19.71, p = 0.04, six RCTs). There was no difference in the number of patients complaining of pain between SH and CH. In the long term (1 year and over), there was a significantly higher rate of prolapse after SH (OR 4.34, 95% CI 1.67 to 11.28, p = 0.003, 12 RCTs). There was no difference in the number of patients experiencing pain, or the incidence of bleeding, between SH and CH. There was no difference in the total number of reinterventions, or reinterventions for pain, bleeding or complications, between SH and CH. Significantly more reinterventions were undertaken after SH for prolapse at 12 months or longer (OR 6.78, 95% CI 2.00 to 23.00, p = 0.002, six RCTs). Overall, there was no statistically significant difference in the rate of complications between SH and CH. In the economic assessment it was found that, on average, CH dominated SH. However, CH and SH had very similar costs and quality-adjusted life-years (QALYs). On average, the difference in costs between the procedures was 19 pounds and the difference in QALY was -0.001, favouring CH, over 3 years. In terms of QALYs, the superior quality of life due to lower pain levels in the early postoperative period with SH was offset by the higher rate of symptoms over the follow-up period, compared with CH. The results are very sensitive to modelling assumptions, particularly the valuation of utility in the early postoperative period. The probabilistic sensitivity analysis showed that, at a threshold incremental cost-effectiveness ratio of 20,000-30,000 pounds per QALY, SH had a 45% probability of being cost-effective. CONCLUSIONS: SH was associated with less pain in the immediate postoperative period, but a higher rate of residual prolapse, prolapse in the longer term and reintervention for prolapse. There was no clear difference in the rate or type of complications associated with the two techniques and the absolute and relative rates of recurrence and reintervention for both are still uncertain. CH and SH had very similar costs and QALYs, the cost of the staple gun being offset by savings in hospital stay. Should the price of the gun change, the conclusions of the economic analysis may also change. Some training may be required in the use of the staple gun; this is not expected to have major resource implications. Given the currently available clinical evidence and the results of the economic analysis, the decision as to whether SH or CH is conducted could primarily be based on the priorities and preferences of the patient and surgeon. An adequately powered, good-quality RCT is required, comparing SH with CH, recruiting patients with second, third and fourth degree haemorrhoids, and having a minimum follow-up period of 5 years to ensure an adequate evaluation of the reintervention rate. Other areas for research are the effectiveness of SH in patients with fourth degree haemorrhoids and patients with co-morbid conditions, the reintervention rates for all treatments for haemorrhoids, utilities of patients up to 6 months postoperatively, the trade-offs of patients for short-term pain versus long-term outcomes, and the ability of SH to reduce hospital stays in a real practice setting.

Diathermy haemorrhoidectomy: reasons for a therapeutic choice.

BACKGROUND: Diathermy haemorrhoidectomy is an effective technique for the management of 2nd, 3rd and 4th degree haemorrhoids. The anal cushions are excised by use of diathermy without ligature of the vascular pedicles. The aim of the present study is to evaluate the efficacy and tolerability of this technique. METHODS: Between September 1999 and September 2003, 84 patients with 2nd, 3rd, and 4th degree haemorrhoids underwent diathermy haemorrhoidectomy. Patients were discharged the same day or the day after. All the patients were asked to complete two questionnaires one on the level of pain they experienced and the other on their expectation of pain. Patients were followed-up for 1 to 4 years (range 12-48 months, mean 20.5). RESULTS: The average pain severity score on a visual analogue scale (0-10) was 3.06 +/- 0.38 and consistently lower than expected. The majority of patients returned to their usual daily activities within 4 days and all of them returned to work within 11 days. A mild residual secretion persisted for 4 to 5 weeks. None of our patients experienced postoperative haemorrhage, complete stenosis or sphincteric disturbances. CONCLUSIONS: Diathermy haemorrhoidectomy appears to be a safe, low cost and effective technique for the treatment of haemorrhoids. It is well tolerated by patients.

Routine surgical pathology in general surgery.

BACKGROUND: Although pathological analysis provides the definitive diagnosis for most resection specimens, recent evidence suggests that such analysis may be omitted for certain routine samples. This was a retrospective analysis of the value of routine histopathological examination performed in daily general surgical practice. METHODS: All specimens from routine appendicectomies, cholecystectomies, haemorrhoidectomies and inguinal hernia repairs performed between 1993 and 2002 were included. The analysis included a comparison of histological and macroscopic diagnoses, review of preoperative and peroperative findings, and an evaluation of the consequences of routine histopathological assessment on patient management and costs. RESULTS: With the exception of hernia specimens, the rate of submission for routine pathological evaluation was 100 per cent. No hernia sac specimen from more than 2000 interventions revealed aberrant histological findings. Of 311 haemorrhoidectomy specimens three showed malignancy, all of which had a suspicious macroscopic appearance. Of 1465 appendices, only one (0.1 per cent) had a potentially relevant histological diagnosis that was not suspected macroscopically. Among 1523 cholecystectomy specimens, all adenomas (0.6 per cent) and carcinomas (0.4 per cent) were suspected macroscopically or developed in association with a known disease. CONCLUSION: The rarity of incidental histological findings relevant to patient management, especially in the absence of macroscopic abnormalities, suggests that routine histological examination of certain specimens may be omitted. A more elementary role for macroscopic examination of the specimen by the surgeon and the pathologist is proposed.

Open haemorrhoidectomy revisited.

The open method of haemorrhoidectomy has been criticized because of slow wound healing, severe pain and prolonged post operative care. This has led to a shift of interest to other methods of haemorrhoidectomy. These grounds of criticism need to be re-appraised for a rational conclusion and recommendation. Thirty nine consecutive patients who had open haemorrhoidectomy between 2nd and 3rd degree haemorrhoids from May, 1998 to April, 1999 were prospectively assessed for wound healing rate and complication rate. There were 26 males and 13 females (ratio 2:1). The average length of hospital stay was 3 days. Post operative pain and acute retention of urine were the commonest complications. The mean wound healing rate was 5 weeks, with a peak (30.8%) in the 5th post operative week. The mean cost of management was thirty eight U.S. Dollars ($38.00) or four thousand, five hundred and ninety three Naira. (N4,593.00). Open haemorrhoidectomy remains a safe and simple surgical technique that should not be discarded in complete preference to newer innovative methods.

[Surgical treatment of hemorrhoidal disease using circular mechanical stapler. Analysis of costs]. / Trattamento chirurgico della malattia emorroidaria mediante suturatrice meccanica circolare. Analisi dei costi.

BACKGROUND: An analysis of surgical treatment costs of haemorrhoid disease with the use of a new circular stapler, is made comparing this operation with Milligan Morgan's technique. The money and management saving due to the reduction of operation time and postoperative stay compensates present costs due to stapler. METHODS: 35 uniform patients (number, age, sex, grade of haemorrhoid disease and surgical equipe) are considered and divided into two groups of study to evaluate perspectively the surgical costs. RESULTS: The cost of treatment with stapler per patient is like Milligan Morgan's treatment (1.714.681 lire versus 1.681.893), with an important management saving of postoperative days (16 hours versus 42 hours). CONCLUSIONS: Moreover there are psychologic and social advantages, not quantifiable but considerable, due to the early physical recovery and to the absence of out-patient dressing cycles peculiar of this surgical technique, with a rapid social and working reinstatement of patients (4-5 days versus 4-5 weeks of conventional intervention).