Background The most widely used classification for hemorrhoidal disease (HD) is the Goligher classification, which ranks presence and severity of prolapse in four grades. Since physicians base this gradation on medical history and physical examination, it might be prone to interobserver variability. Furthermore, the gradation impacts the treatment of choice which makes reproducibility of utmost importance. The aim of this study was to determine the interobserver variability of Goligher classification among surgeons in the Netherlands. Methods A single-choice survey was used. The first part consisted of questions concerning baseline characteristics and the use of the Goligher classification in routine clinical practice. In the second part, to assess interobserver variability, we asked gastrointestinal surgeons and residents who routinely treat HD to review 25 photographs (with given timing as during rest or push) of patients with HD and classify the gradation using the Goligher classification. The survey was sent by email on April 19, 2021 and was available online until July 5, 2021. Interobserver variability was assessed using Fleiss’ Kappa test. Results A total of 329 gastrointestinal surgeons, fellows and residents were sent an invitation email, of whom 95 (29%) completed the survey. Among the respondents, 87% indicated that they use the Goligher classification in clinical practice. Eighty-one percent found the classification helpful and 63% classified HD according to Goligher and followed the guidelines for treatment of HD accordingly. The interobserver variability showed an overall fair strength of agreement, with a Fleiss’ Kappa (κ) of 0.376 (95% CI 0.373–0.380). There was a moderate agreement for grade I and IV HD with a κ statistic of 0.466 and 0.522, respectively. For grades II and III, there was a lower (fair) strength of agreement with 0.206 and 0.378, respectively. Conclusions The fair interobserver variability is disappointing and demonstrates the need for a more reliable, and internationally accepted, classification for HD. A new classification should enable more uniformity in treating HD and in comparing outcomes of future trials and prospective registries. The protocol for a Delphi study for a new classification system is currently being prepared and led by an international research group.
Background The aim of this study was to review clinical outcome of haemorrhoidectomy and rubber band ligation in grade II–III haemorrhoids. Methods A systematic review was conducted. Medline, Embase, Cochrane Library, Clinicaltrials.gov, and the WHO International Trial Registry Platform were searched, from inception until May 2018, to identify randomised clinical trials comparing rubber band ligation with haemorrhoidectomy for grade II–III haemorrhoids. The primary outcome was control of symptoms. Secondary outcomes included postoperative pain, postoperative complications, anal continence, patient satisfaction, quality of life and healthcare costs were assessed. Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines were followed. Results Three hundred and twenty-four studies were identified. Eight trials met the inclusion criteria. All trials were of moderate methodological quality. Outcome measures were diverse and not clearly defined. Control of symptoms was better following haemorrhoidectomy. Patients had less pain after rubber band ligation. There were more complications (bleeding, urinary retention, anal incontinence/stenosis) in the haemorrhoidectomy group. Patient satisfaction was equal in both groups. There were no data on quality of life and healthcare costs except that in one study patients resumed work more early after rubber band ligation. Conclusions Haemorrhoidectomy seems to provide better symptom control but at the cost of more pain and complications. However, due to the poor quality of the studies analysed/it is not possible to determine which of the two procedures provides the best treatment for grade II–III haemorrhoids. Further studies focusing on clearly defined outcome measurements taking patients perspective and economic impact into consideration are required.
Background Management of cryptoglandular fistula-in-ano (FIA) can be challenging. Despite Dutch and international guidelines determining optimal therapy is still quite difficult. The aim of this study was to report current practices in the management of cryptoglandular FIA among gastrointestinal surgeons in the Netherlands. Methods Dutch surgeons and residents who are treating FIA regularly were sent a survey invitation by email. The survey was available online from September 19 to December 1 2019. The questionnaire consisted of 28 questions concerning diagnostic and surgical techniques in the treatment of intersphincteric and transsphincteric FIA. Results In total, 147 (43%) surgeons responded and completed the survey. Magnetic resonance imaging was the preferred diagnostic imaging modality (97%) followed by the endo-anal ultrasound (12%). In case of a high FIA, 86% used a non-cutting seton. Most respondents removed a seton between 6 weeks and 3 months (n = 84, 58%). Fistulotomy was the procedure of preference in low transsphincteric (86%) and low intersphincteric FIA (92%). Mucosal advancement flap (MAF) and ligation of intersphincteric fistula tract (LIFT), with 78% and 46%, respectively, were the procedures that were applied most often in high transsphincteric FIA. In high intersphincteric FIA 67% performed a MAF and 33% a fistulotomy. Thirty-three percent of all respondents stated that they habitually closed the internal fistula opening, half of them used a Z-plasty. For debridement of the fistula tract the preferred method was curettage (78%). Conclusions Dutch gastrointestinal surgeons use various techniques in the management of FIA. Novel promising techniques should be investigated adequately in sufficient large trials to increase consensus. A core outcome measurement and a prospective international database would help in comparing results. Until then, treatment should be adjusted to the individual patient, governed by fistula characteristics and patient choice.
Background Chronic anal fissure (CAF) is a common, bothersome condition frequently accompanied by pelvic floor complaints. Despite current guidelines, optimal management is challenging. The aim of this study is to evaluate current management of CAF among gastrointestinal surgeons in the Netherlands. Methods Dutch gastrointestinal surgeons and residents were sent a survey invitation by email, which was available online between June 2021 and September 2021. The questionnaire consisted of 21 questions concerning work experience, physical examination, diagnostic and surgical techniques, and follow-up. Results Overall, 106 (33%) respondents completed the survey. Most respondents (59%) had at least 10 years of experience in treating CAF. Only 23% always addressed pelvic floor complaints. Fifty-one percent performed digital rectal examination and 22% always, or almost always, examined the pelvic floor muscles. Most respondents started treatment with fibers and/or laxatives and ointment (96%). Diltiazem was in 90% the preferred ointment. Twenty-two percent referred patients for pelvic floor physical therapy. Botulinum toxin was in 54% performed under general or spinal anesthesia or sedation. The surgical procedure of choice was fissurectomy (71%) followed by lateral internal sphincterotomy (27%). Fissurectomy was in 51% always combined with botulinum toxin. Fifty-seven percent of the respondents preferred a physical follow-up appointment. Conclusion Guideline recommendations are largely followed in the Netherlands, starting with conservative measures followed by surgical procedures. Surgeons do not consistently assess pelvic floor complaints, nor do they routinely examine the pelvic floor muscles. Awareness of pelvic floor dysfunctions is important to refer patients for pelvic floor physical therapy.
IntroductionHaemorrhoidal 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 analysisThis 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 disseminationThe 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 numbersNCT04621695, NTR8020
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