European Society of Coloproctology Core Outcome Set for haemorrhoidal disease: an international Delphi study among healthcare professionals.

AIM: There is considerable heterogeneity in outcomes in studies reporting on the treatment of haemorrhoidal disease (HD). The aim of this study was to develop a Core Outcome Set (COS) for HD in cooperation with the European Society of Coloproctology. METHOD: A Delphi study was performed according to the Outcome Measures in Rheumatology (OMERACT) methodology. In total 38 healthcare professionals and 30 patients were invited to the panel. Previously, 10 outcome domains and 59 outcomes were identified through a systematic literature review. In this study, these domains and outcomes were formed into one questionnaire for healthcare professionals and a separate questionnaire for patients. Sequential questionnaire rounds prioritizing the domains and outcomes were conducted. Panel members were asked to rate the appropriateness of each domain and outcome on a nine-point Likert scale. During a face-to-face meeting, healthcare professionals agreed on the primary and secondary end-points of the COS for HD. Finally, a short survey was sent to the healthcare professionals in order to reach consensus on how the chosen end-points should be assessed and at which time points. RESULTS: The response rate in questionnaire round 1 for healthcare professionals was 44.7% (n = 17). Sixteen out of 17 healthcare professionals also completed the questionnaire in round 2. The response rate for the patient questionnaire was 60% (n = 18). Seventeen healthcare professionals participated in the face-to-face meeting. The questionnaire rounds did not result in a clear-cut selection of primary and secondary end-points. Most domains and outcomes were considered important, and only three outcomes were excluded. During the face-to-face meeting, agreement was reached to select the domain 'symptoms' as primary end-point, and 'complications', 'recurrence' and 'patient satisfaction' as secondary end-points in the COS for HD. Furthermore, consensus was reached that the domain 'symptoms' should be a patient reported outcome measure and should include the outcomes 'pain' and 'prolapse', 'itching', 'soiling' and 'blood loss'. The domain 'complications' should include the outcomes 'incontinence', 'abscess', 'urinary retention', 'anal stenosis' and 'fistula'. Consensus was reached to use 'reappearance of initial symptoms' as reported by the patient to define recurrence. During an additional short survey, consensus was reached that 'incontinence' should be assessed by the Wexner Fecal Incontinence Score, 'abscess' by physical examination, 'urinary retention' by ultrasonography, 'anal stenosis' by physical examination, and 'fistula' by physical examination and MR imaging if inconclusive. During follow-up, the outcome 'symptoms' should be assessed at baseline, 7 days, 6 weeks and 1 year post-procedure. The outcomes 'abscess' and 'urinary retention' should be assessed 7 days post-procedure and 'incontinence', 'anal stenosis' and 'fistula' 1 year post-procedure. CONCLUSIONS: We developed the first European Society of Coloproctology COS for HD based on an international Delphi study among healthcare professionals. The next step is to incorporate the patients' perspective in the COS. Use of this COS may improve the quality and uniformity of future research and enhance the analysis of evidence.

Hemorrhoids: Diagnosis and Treatment Options.

Many Americans between 45 and 65 years of age experience hemorrhoids. Hemorrhoidal size, thrombosis, and location (i.e., proximal or distal to the dentate line) determine the extent of pain or discomfort. The history and physical examination must assess for risk factors and clinical signs indicating more concerning disease processes. Internal hemorrhoids are traditionally graded from I to IV based on the extent of prolapse. Other factors such as degree of discomfort, bleeding, comorbidities, and patient preference should help determine the order in which treatments are pursued. Medical management (e.g., stool softeners, topical over-the-counter preparations, topical nitroglycerine), dietary modifications (e.g., increased fiber and water intake), and behavioral therapies (sitz baths) are the mainstays of initial therapy. If these are unsuccessful, office-based treatment of grades I to III internal hemorrhoids with rubber band ligation is the preferred next step because it has a lower failure rate than infrared photocoagulation. Open or closed (conventional) excisional hemorrhoidectomy leads to greater surgical success rates but also incurs more pain and a prolonged recovery than office-based procedures; therefore, hemorrhoidectomy should be reserved for recurrent or higher-grade disease. Closed hemorrhoidectomy with diathermic or ultrasonic cutting devices may decrease bleeding and pain. Stapled hemorrhoidopexy elevates grade III or IV hemorrhoids to their normal anatomic position by removing a band of proximal mucosal tissue; however, this procedure has several potential postoperative complications. Hemorrhoidal artery ligation may be useful in grade II or III hemorrhoids because patients may experience less pain and recover more quickly. Excision of thrombosed external hemorrhoids can greatly reduce pain if performed within the first two to three days of symptoms.

Systematic review and network meta-analysis comparing clinical outcomes and effectiveness of surgical treatments for haemorrhoids.

BACKGROUND: The aim was to compare the clinical outcomes and effectiveness of surgical treatments for haemorrhoids. METHODS: Randomized clinical trials were identified by means of a systematic review. A Bayesian network meta-analysis was performed using the Markov chain Monte Carlo method in WinBUGS. RESULTS: Ninety-eight trials were included with 7827 participants and 11 surgical treatments for grade III and IV haemorrhoids. Open, closed and radiofrequency haemorrhoidectomies resulted in significantly more postoperative complications than transanal haemorrhoidal dearterialization (THD), LigaSure™ and Harmonic® haemorrhoidectomies. THD had significantly less postoperative bleeding than open and stapled procedures, and resulted in significantly fewer emergency reoperations than open, closed, stapled and LigaSure™ haemorrhoidectomies. Open and closed haemorrhoidectomies resulted in more pain on postoperative day 1 than stapled, THD, LigaSure™ and Harmonic® procedures. After stapled, LigaSure™ and Harmonic® haemorrhoidectomies patients resumed normal daily activities earlier than after open and closed procedures. THD provided the earliest time to first bowel movement. The stapled and THD groups had significantly higher haemorrhoid recurrence rates than the open, closed and LigaSure™ groups. Recurrence of haemorrhoidal symptoms was more common after stapled haemorrhoidectomy than after open and LigaSure™ operations. No significant difference was identified between treatments for anal stenosis, incontinence and perianal skin tags. CONCLUSION: Open and closed haemorrhoidectomies resulted in more postoperative complications and slower recovery, but fewer haemorrhoid recurrences. THD and stapled haemorrhoidectomies were associated with decreased postoperative pain and faster recovery, but higher recurrence rates. The advantages and disadvantages of each surgical treatment should be discussed with the patient before surgery to allow an informed decision to be made.

Portal pyaemia secondary to open haemorrhoidectomy: need for prophylactic broad spectrum antibiotics.

A 70-year-old man presenting with long standing grade 3 Haemorrhoids, underwent open haemorrhoidectomy under spinal anaesthesia. The patient passed stools on subsequent day and there was no bleeding per rectum. On day 5, he complained of dull aching upper abdominal pain. On physical examination, the abdomen was soft and there was mild tenderness in the epigastric region. Subsequently, he developed high temperature with chills and rigors. His condition failed to improve and the abdominal pain increased in severity. There was no pain in the perianal region and per rectum examination was normal. Leucocyte count rose to 12×10(9)/L and there were toxic changes on peripheral smear. Blood culture grew Staphylococcus aureus. Liver enzymes were mildly elevated. Coagulation profile was deranged. Fibrin degradation products were positive. D-dimer was high. CT revealed acute thrombosis of left portal vein and microabscesses suggestive of portal pyaemia.

Ferguson hemorrhoidectomy: is still the gold standard treatment?

Hemorrhoidectomy remains the most definitive procedure to treat symptomatic grades III and IV hemorrhoids. However, over the years, several modifications have been made to the original operation to improve the outcomes. A total of 693 consecutive patients with grade III and IV hemorrhoids underwent Ferguson hemorrhoidectomy. Our results serve as a standard for comparison conventional hemorrhoidectomy (Ferguson's technique) with recent methods such as stapled hemorrhoidopexy and LigaSure hemorrhoidectomy. We have obtained a very low rate of post-operative pain after Ferguson hemorrhoidectomy (VAS pain score was 2.47 ± 1.1 after a day, 1.34 ± 0.7 after 7 days and 0.51 ± 0.1 after 2 weeks) as to for stapler and LigaSure procedure in the literature. Moreover, long-term results demonstrate high levels of patient satisfaction (the satisfaction was good in 624 patients after 2 weeks and in 658 patients after 1 year) with a low recurrence rates (7 patients had recurrence after 1 year and 21 patients after 2 years). We believe that Ferguson-closed hemorrhoidectomy could still be, at the moment, the gold standard to which other techniques are compared.