Prospective randomised multi-centre trial comparing the clinical efficacy, safety and patient acceptability of circular stapled anopexy with closed diathermy haemorrhoidectomy. How we can improve patients' comfort after Milligan-Morgan open haemorrhoidectomy. Prospective randomized controlled trial of a micronized flavonidic fraction to reduce bleeding after haemorrhoidectomy. Clinical use of micronized purified flavonoid fraction for treatment of symptoms after hemorrhoidectomy: results of a randomized, controlled, clinical trial. Prospective randomized multicentre trial comparing stapled with open haemorrhoidectomy. Flavonoids to reduce bleeding and pain after stapled hemorrhoidopexy: a randomized controlled trial. Randomized clinical trial of micronized flavonoids in the early control of bleeding from acute internal haemorrhoids. Long-term results after excision haemorrhoidectomy versus stapled haemorrhoidopexy for prolapsing haemorrhoids; a Belgian prospective randomized trial. Randomised trial comparing LigaSure haemorrhoidectomy with the diathermy dissection operation.
Unlike excisional haemorrhoidectomy, stapled anopexy (SA), which does not involve radical excision, has theoretical advantages, thus offering potential patient benefits. We compared the clinical efficacy, safety and patient acceptability of SA, with closed haemorrhoidectomy (CH).
                182 patients with symptomatic haemorrhoids (grades II, III, IV) were randomly assigned to receive SA or CH and were followed for up to 1 year (6, 12, 24, 48 weeks) after operation. Postoperative pain, symptom control, complications, re-treatment rates, patient satisfaction, and quality of life were compared on an intention-to-treat basis.
                Postoperative pain in the SA group (n = 91) was significantly lower (p = 0.004, Mann-Whitney U test). At 1 year there were no significant differences in the symptom load, symptom severity or the disease severity between the two groups. Overall complication rates were similar but faecal urgency was reported more frequently following SA (p = 0.093, Fisher's exact test). Despite a similar rate of residual symptoms, prolapse control was better with CH (p = 0.087, Fisher's exact test), and more patients in the SA group required re-treatment for residual prolapse at 1 year (p = 0.037, Fisher's exact test). However, more patients rated SA as an excellent operation at 6 and 12 weeks (p = 0.008 and 0.033, binary logistic regression) and were willing to undergo a repeat procedure if required (p = 0.018, Fisher's exact test).
                Stapled anopexy offers a significantly less painful alternative to excisional haemorrhoidectomy and achieves a higher patient acceptability. Although the overall symptom control and safety are similar in the majority of the patients, the re-treatment rate for recurrent prolapse at 1 year is higher following SA when compared to CH. To demonstrate the value of Diosmin (flavonidic fraction) in the management of post-haemorhoidectomic symptoms.
                Eighty-six consecutive patients with grades III and IV acute mixed hemorrhoids admitted to the Anorectal Surgical Department of First Affiliated Hospital, Xinjiang Medical University from April 2009 to April 2010, were enrolled in this study. An observer-blinded, randomized trial was conducted to compare post-haemorhoidectomic symptoms with use of Diosmin flavonidic fraction vs placebo. Eighty-six patients were randomly allocated to receive Diosmin flavonidic fraction 500 mg for 1 wk (n = 43) or placebo (n = 43). The Milligan-Morgan open haemorrhoidectomy was performed by a standardized diathermy excision method. Pain, bleeding, heaviness, pruritus, wound edema and mucosal discharge were observed after surgery. The postoperative symptoms and hospitalization time were recorded.
                The mean age of the Diosmin group and controls was 53.2 and 51.3 years, respectively. In Diosmin group, haemorrhoid piles were of the third degree in 33 patients and the fourth degree in 10; and in the control group, 29 were of the third degree and 14 were of the fourth degree. There was no statistically significance in age, gender distribution, degree and number of excised haemorrhoid piles, and the mean duration of haemorrhoidal disease between the two groups. There was a statistically significant improvement in pain, heaviness, bleeding, pruritus from baseline to the 8th week after operation (P < 0.05). Patients taking Diosmin had a shorter hospitalization stay after surgery (P < 0.05). There was also a significant improvement on the proctoscopic appearance (P < 0.001). However, there was no statistical difference between the two groups in terms of wound mucosal discharge. Two patients experienced minor bleeding at the 8th week in Diosmin group, and underwent surgery.
                Diosmin is effective in alleviating postoperational symptoms of haemorrhoids. Therefore, it should be considered for the initial treatment after haemorrhoid surgery. However, further prospective randomized trials are needed to confirm the findings of this study. A prospective randomized controlled trial was carried out on the effects of Daflon 500 mg (a micronized flavonidic fraction containing diosmin 450 mg and hesperidin 50 mg) on bleeding after haemorrhoidectomy. In all, 228 consecutive patients with prolapsed irreducible piles were recruited. Elective haemorrhoidectomy was performed with a standardized diathermy excision method. Some 114 patients were randomized to receive Daflon 500 mg for 1 week after operation (group 1), and there were 114 controls (group 2). Postoperative analgesia and laxative prescription as well as hospital stay were otherwise the same. One patient (0.9 per cent) from group 1 and seven (6.1 per cent) from group 2 had postoperative bleeding (P = 0.03). All bleeding occurred from 6 to 15 days after haemorrhoidectomy. There were no side-effects from the use of Daflon 500 mg. The risk of secondary bleeding from haemorrhoidectomy is reduced with postoperative Daflon. The aim of this study was to evaluate if the combination of micronized purified flavonoid fraction with short-term routine antibiotic and anti-inflammatory therapy was better at reducing the intensity of postoperative symptoms and wound bleeding after a Milligan-Morgan's open hemorrhoidectomy than antibiotic and anti-inflammatory treatment alone.
                Fifty patients were randomly assigned to receive routine antibiotic and anti-inflammatory treatment alone (control patients) or a combination of micronized purified flavonoid fraction with identical antibiotic and anti-inflammatory treatment (micronized purified flavonoid fraction patients). The evolution of symptoms (pain, tenesmus, pruritus, and bleeding) during the postoperative period was assessed by means of patients' self-questionnaires. Each symptom was scored on a graded severity scale from 0 to 3, daily during the first three days of the immediate postoperative period, then at regular intervals (about every 14 days) until postoperative day 60. A global score for evaluation of each postoperative symptom and bleeding was used. The global score for each symptom was the sum of scores for each patient over the study period. The global score for each symptom was compared between the two groups with the Mann-Whitney U test.
                No significant differences in age, gender distribution, and stage of disease between the two groups were noticed at baseline. Posthemorrhoidectomy symptoms were relieved more rapidly in the micronized purified flavonoid fraction group; during the first three postoperative days, the global score for each symptom was significantly more reduced in the micronized purified flavonoid fraction group. The global scores for each symptom are as follows: pain after 3 days, 6.16 (SD = 1.9) in the control group vs. 3.48 (SD = 1.8) in the micronized purified flavonoid fraction group (P < 0.0001); tenesmus, 5.36 (SD = 1.8) in the control group vs. 1.48 (SD = 1.5) in the micronized purified flavonoid fraction group (P < 0.0001); pruritus, 4.04 (SD = 1.9) in the control group vs. 1.84 (SD = 1.4) in the micronized purified flavonoid fraction group (P < 0.0001); bleeding, 4.4 (SD = 2.1) in the control group vs. 2.0 (SD = 1.3) in the micronized purified flavonoid fraction group (P < 0.0001). A significant difference (P < 0.0001) between groups was also shown in favor of micronized purified flavonoid fraction patients when global scores were calculated over the entire study period (60 days).
                Micronized purified flavonoid fraction used in combination with short-term antibiotic and anti-inflammatory treatment can reduce both the duration and extent of postoperative symptoms and wound bleeding following hemorrhoidectomy. The aim of this study was to compare the results of conventional open haemorrhoidectomy as currently practised in Italy (group 1) with stapled haemorrhoidectomy using a 33-mm circular stapling device (group 2).
                One hundred patients with symptomatic third- and fourth-degree haemorrhoids were enrolled by five hospitals. Patients were allocated to the two groups according to a centralized randomization scheme featuring five permutated blocks of 20. Preoperative clinical examination and anorectal manometry demonstrated no features of anal incontinence. Patients had a clinical and manometric re-evaluation after operation and were asked to complete a clinical diary. After a median of 16 (range 8-19) months patients were administered a standardized questionnaire by telephone.
                Postoperative bleeding requiring haemostatic procedures occurred in three patients in each group. Patients in group 1 complained of moderate pain for a median of 5.3 (range 0-19) days compared with 3.1 (range 0-10) days in group 2 (P = 0.01), while severe pain was present for 2.3 (range 0-24) days in group 1 but only for 1 (range 0-14) day in group 2 (P = 0.03). The median hospital stay was 2 days in group 1 compared with 1 day in group 2 (P = 0.01). In the early days after operation, patients in group 2 had greater difficulty in maintaining normal continence to liquid stools (P = 0.01), but after 30 days the continence score was better in group 2 (P = 0.04).
                Stapled haemorrhoidectomy is as effective as conventional haemorrhoidectomy. Reduced postoperative pain, shorter hospital stay and a trend toward earlier return to work suggest short-term advantages for the stapled technique. Control of postoperative symptoms is of paramount importance in ambulatory surgery. This trial was conducted to evaluate whether a micronized purified flavonoid fraction (MPFF) (Detralex((R))) reduces postoperative bleeding, pain and consumption of analgesics after ambulatory stapled hemorrhoidopexy, as reported in trials after classic hemorrhoidectomy. Phlebotropic activity, protective effect on the capillaries and anti-inflammatory properties of this drug have been reported in several studies.
                Sixty-three patients with third-degree hemorrhoids had ambulatory stapled hemorrhoidopexy under spinal anesthesia in the period of one year. The patients were randomized, with 30 receiving Detralex 500 mg (2 tablets 3 times daily for 5 days after the operation) and 33 forming the control group. The patients were asked to daily self-assess the presence of blood on defecation, degree of pain and consumption of analgesics for the first week after the operation.
                There was no significant difference between the two groups in duration of presence of blood, degree of pain or analgesics requirement. No major complications, such as bleeding requiring transfusion or hospitalization, sepsis, anal stenosis or urgent defecation, were noted in the follow-up period. There were no side effects from Detralex treatment.
                In our study we could not demonstrate any positive effect of prescribing flavonoids after stapler hemorrhoidopexy. This procedure may not be sufficiently aggressive and is associated with too few postoperative complications to show any protective influence of flavonoids. Patients with acute bleeding from internal haemorrhoids often have to be referred by the general practitioner to the surgeon for definitive treatment with invasive outpatient procedures. At the initial consultation, patients frequently seek postponement of immediate surgery to a more convenient time. Effective and rapid non-invasive control of acute bleeding could be of practical use in scheduling surgery to a time convenient to both patient and surgeon.
                In a 90-day randomized, double-blind study treatment with a micronized purified flavonoid fraction (MPFF) was compared with placebo, in 100 outpatients who presented for treatment of acute internal haemorrhoids of less than 3 days' duration. The primary endpoint was cessation of bleeding on the third day of treatment.
                Of 50 patients randomized to each group, acute bleeding ceased by the third day in 40 (80 per cent) who received MPFF compared with 19 (38 per cent) who had placebo (P < 0.01). Mean(s.d. ) duration of acute bleeding from onset to cessation of 4.9(1.6) days was 2.1 (95 per cent confidence interval 1.2-2.9) days less than that in patients receiving placebo (P < 0.01). Continued treatment in patients with no bleeding prevented a relapse in 30 of 47 patients, compared with 12 of 30 receiving placebo (P < 0.05).
                Patients with acute internal haemorrhoids treated with MPFF had rapid cessation of bleeding and a reduced risk of relapse. This could be of value in the more convenient timing of treatment with invasive outpatient procedures. To compare the postoperative evolution and the long-term efficacy after stapled haemorrhoidopexy (PPH) and Milligan-Morgan haemorrhoidectomy (MM).
                In a prospective randomized study, 40 patients requiring surgical treatment for prolapsing haemorrhoids grade II or III were assigned to either MM or PPH (20 each). Postoperative pain, wound healing were evaluated, as well as anal pressures and sphincter anatomy. Mean follow-up is 46 months.
                Postoperative pain at rest and during defecation was less important after PPH if no resection of external piles or skin tags was associated (P < 0.0001). Healing time was shorter after PPH (P < 0.0001). Endoanal ultrasound remained unchanged postoperatively. Resting and squeeze pressures decreased after MM, but not after PPH (P < 0.01). After a mean follow-up of 46 months (12-56), persistent or recurrent symptoms, mostly mild and temporary, were observed after both MM and PPH, in 7 and 11 patients respectively (NS). After PPH, five patients (25%) complained of recurrent external swelling and/or prolapse (P = 0.047 vs. MM) requiring redo surgery in four of them, after 10, 13, 14 and 21 months. No redo-surgery was required after MM. Long term patient satisfaction after PPH was not better than after MM.
                Postoperative pain is less important after PPH. This advantage disappears if any resection is associated with the stapling. At medium to long-term follow-up, PPH seems to carry a higher risk of symptomatic external haemorrhoidal disease, needing further surgery. The study was designed to compare LigaSure haemorrhoidectomy with open haemorrhoidectomy performed by means of diathermy excision. Fifty-sixty consecutive patients with third- and fourth-degree haemorrhoids were randomly allocated to undergo either LigaSure haemorrhoidectomy (29 patients) or diathermy haemorrhoidectomy (27 patients). All patients were evaluated for operative time, pain, post-operative analgesic requirements, time to first bowel movement, length of hospital stay, wound healing period, time to return to work, and occurrence of early postoperative complications (such as urinary dysfunction, bleeding, soiling, seepage, continence disorders) and late complications (such as stenosis). A statistically significant advantage was observed in the patients who received the LigaSure technique as far as concerns length of operative time (9.2 vs. 12.2 min, p<0.001), post-operative analgesic requirements (14.1 vs. 16.8 administrations, p<0.001), wound healing period (16.3 vs. 37.5 days, p< 0.0001), and time to return to work (8.3 vs. 18.3 days, p<0.01). No significant difference was seen in the postoperative pain score, complications rate, first bowel motion or hospital stay. No recurrence was observed at the 6-month follow-up. In conclusion, our experience shows that the LigaSure haemorrhoidectomy offers definite advantages over the classic diathermy technique. This procedure is easier, safer, and more rapid to perform and is followed by a faster wound healing time, a significantly shorter hospital stay, less postoperative pain and faster wound healing.
The evidence suggests that there is a potential benefit in using phlebotonics in treating haemorrhoidal disease as well as a benefit in alleviating post-haemorrhoidectomy symptoms. Outcomes such as bleeding and overall symptom improvement show a statistically significant beneficial effect and there were few concerns regarding their overall safety from the evidence presented in the clinical trials.
However methodological limitations were encountered. In order to enhance our conclusion further, more robust clinical trials which take into account these limitations will need to be performed in the future.