Stapled hemorrhoidopexy vs. diathermy excision for fourth-degree hemorrhoids: a randomized, clinical trial and review of the literature. Randomized comparison between stapled hemorrhoidopexy and Ferguson hemorrhoidectomy for grade III hemorrhoids in Taiwan: a prospective study. A prospective, randomized, controlled multicenter trial comparing stapled hemorrhoidopexy and Ferguson hemorrhoidectomy: perioperative and one-year results. Prospective randomised multi-centre trial comparing the clinical efficacy, safety and patient acceptability of circular stapled anopexy with closed diathermy haemorrhoidectomy. Long-term results after excision haemorrhoidectomy versus stapled haemorrhoidopexy for prolapsing haemorrhoids; a Belgian prospective randomized trial. Randomized clinical trial of stapled haemorrhoidopexy versus conventional diathermy haemorrhoidectomy. Hemorrhoidal stapler prolapsectomy vs. Milligan-Morgan hemorrhoidectomy: a long-term randomized trial. Stapled hemorrhoidopexy vs. Harmonic Scalpel hemorrhoidectomy: a randomized trial. Randomized clinical trial of stapled hemorrhoidectomy vs open with Ligasure for prolapsed piles.
The aim of this prospective study was to compare the results of stapled hemorrhoidopexy with those of conventional diathermy excision for controlling symptoms in patients with fourth-degree hemorrhoids.
                Thirty-one patients with symptomatic, prolapsed irreducible piles were randomized to either stapled hemorrhoidopexy (n = 15) or diathermy excision (n = 16). The primary outcome measure was the control of hemorrhoidal symptoms one year after operation.
                The two procedures were comparable in terms of pain relief and disappearance of bleeding. Recurrent prolapse starting from the fourth month after operation was confirmed in 8 of 15 patients in the stapled group and in none in the diathermy excision group: two-tailed Fisher's exact test P = 0.002, RR 0.33, 95 percent confidence interval 0.19-0.59). Five of these patients responded well to a later conventional diathermy hemorrhoidectomy. Persistence of itching was reported in six patients in the stapled group and in one of the diathermy excision group (P = 0.03). On the other hand, six patients in the stapled group and none in the diathermy excision group experienced tenesmus (P = 0.007).
                Stapled hemorrhoidopexy was not effective as a definitive cure for the symptoms of prolapse and itching in patients with fourth-degree hemorrhoids. Moreover, stapled hemorrhoidopexy induced the appearance of a new symptom, tenesmus, in 40 percent of the patients. Therefore conventional diathermy hemorrhoidectomy should continue to be recommended in patients with symptomatic, prolapsed, irreducible piles. Short-term and mid-term outcomes of stapled hemorrhoidopexy (SH) were compared with those for Ferguson hemorrhoidectomy (FH) for treating hemorrhoids.
                Patients with prolapsed hemorrhoids were randomized into two groups treated with SH (N = 300) and FH (N = 296) at Chang Gung Memorial Hospital at Chiayi in Taiwan between January 2002 and December 2004. The outcomes of the procedures were evaluated postoperatively (short-term, i.e., intra-/postoperative conditions, hospital stay, pain intensity scoring, time off work, and procedure-related morbidity) and over a follow-up period of minimum 18 months (mid-term, i.e., relapse of prolapse and/or bleeding, anal stricture, anal sepsis, and the acceptability of the procedures to the patients).
                SH was superior to FH in operative time, intraoperative blood loss, postoperative pain intensity, and return to work. Based on telephone interviews over the follow-up period, most patients who received SH appreciated the procedure better than those with FH.
                This study confirms that SH generates less postoperative suffering, less time off work, and more complete resolution of primary symptoms associated with hemorrhoids in the mid-term follow-up than FH. There is a growing body of evidence supporting the lesser degrees of pain with stapled hemorrhoidopexy, also called the procedure for prolapse and hemorrhoids. However, there have been few randomized comparisons assessing both perioperative and long-term outcomes of the procedure for prolapse and hemorrhoids and Ferguson hemorrhoidectomy. Results are presented here from the first prospective, randomized, multicenter trial comparing these hemorrhoid procedures in the United States.
                Patients with prolapsing hemorrhoids (Grade III) were randomized to undergo the procedure for prolapse and hemorrhoids or Ferguson hemorrhoidectomy by colorectal surgeons who had training in using the stapling technique. Primary end points were acute postoperative pain, and hemorrhoid symptom recurrence requiring additional treatment at one-year follow-up from surgery.
                A total of 156 patients (procedure for prolapse and hemorrhoids, 77; Ferguson, 79) completed randomization and the surgical procedure, 18 (procedure for prolapse and hemorrhoids, 12; Ferguson, 6) had significant protocol violations. One hundred seventeen patients (procedure for prolapse and hemorrhoids, 59; Ferguson, 58) returned for one-year follow-up. Demographic parameters, hemorrhoid symptoms, preoperative pain scores, and bowel habits were similar between groups. There were a similar number of patients with adverse events in each group (procedure for prolapse and hemorrhoids, 28 (36.4 percent) vs. Ferguson, 38 (48.1 percent); P = 0.138). Reoperation for an adverse effect was required in six (7.6 percent) Ferguson patients and in 0 patients having the procedure for prolapse and hemorrhoids (P = 0.028). Postoperative pain during the first 14 days, pain at first bowel movement, and need for postoperative analgesics were significantly less in the procedure for prolapse and hemorrhoids group. Control of hemorrhoid symptoms was similar between groups; however, significantly fewer patients having the procedure for prolapse and hemorrhoids required additional anorectal procedures during one-year follow-up (procedure for prolapse and hemorrhoids, 2 (2.6 percent), vs. Ferguson, 11 (13.9 percent); P = 0.01). Only four of the Ferguson patients (5 interventions) required additional procedures more than 30 days after surgery.
                These data demonstrate that stapled hemorrhoidopexy offers the benefits of less postoperative pain, less requirement for analgesics, and less pain at first bowel movement, while providing similar control of symptoms and need for additional hemorrhoid treatment at one-year follow-up from surgery. 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 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 aim of this study was to compare the results of stapled haemorrhoidopexy (commonly called stapled haemorrhoidectomy) with those of conventional diathermy haemorrhoidectomy.
                Fifty-five patients with symptomatic third- and fourth-degree haemorrhoids were randomized to either stapled haemorrhoidopexy (n = 27) or conventional diathermy haemorrhoid ectomy (n = 28). Operating time, postoperative pain, time to return to work, postoperative complications and effectiveness of haemorrhoidal symptom control were recorded. The mean follow-up was 15.9 months in the stapled haemorrhoidopexy group and 15.2 months in the conventional haemorrhoidectomy group.
                Mean pain intensity was significantly less in the stapled group (P = 0.001). There were no significant differences in the total number of complications, the length of absence from work or control of symptoms. Seven patients in the stapled group re-presented with prolapse compared with none in the conventional haemorrhoidectomy group (P = 0.004). This difference was also observed in the subset of patients with fourth-degree haemorrhoids (P = 0.003).
                The stapled operation was significantly less painful than conventional haemorrhoidectomy. However, the rate of recurrent prolapse was higher after stapled haemorrhoidopexy than after conventional diathermy haemorrhoidectomy. The notable success of stapled prolapsectomy in recent years led us to compare this technique with Milligan-Morgan hemorrhoidectomy in terms of the results obtained both in the immediate postoperative period and in the long term.
                We performed conventional hemorrhoidectomy on 50 randomly selected patients and operated on a further 50 using the stapler technique. The patients were monitored over the immediate postoperative period (e.g., type of anesthesia, mean duration of operation, mean hospitalization time, analgesic administration, time before returning to work) and over a long-term follow-up period of 48 months (later complications such as prolapse relapse, bleeding, stenosis, incontinence).
                The stapled group experienced significantly less pain (mean number of analgesic tablets 2.60 vs. 15.9) and returned to normal activity sooner (8.04 vs. 16.9 days), as reported by other authors. In the long-term follow-up at 48 months, stapled hemorrhoidectomy was found to control prolapse, discharge, and bleeding, with no stenosis or significant incontinence, in 94% of cases.
                Our conclusions confirm the excellent advantages of stapled hemorrhoidectomy which allows the rapid recovery of patients and also promises the complete resolution of hemorrhoidal prolapse in the long term. A randomized trial was undertaken to evaluate and compare stapled hemorrhoidopexy with excisional hemorrhoidectomy in which the Harmonic Scalpel was used.
                Patients with Grade III hemorrhoids who were employed during the trial period were recruited and randomized into two groups: (1) Harmonic Scalpel hemorrhoidectomy, and (2) stapled hemorrhoidopexy. All operations were performed by a single surgeon. In the stapled group, the doughnut obtained was sent for histopathologic examination to determine whether smooth muscles were included in the specimen. Operative data and complications were recorded, and patients were followed up through a structured pro forma protocol. An independent assessor was assigned to obtain postoperative pain scores and satisfaction scores at six-month follow-up. Patients were also administered a simple questionnaire at follow-up to assess continence functions.
                Over a 20-month period, 88 patients were recruited. The two groups were matched for age and gender distribution. No significant difference was identified between the two groups in terms of operation time, blood loss, day of first bowel movement after surgery, and complication rates. Despite a similar parenteral and oral analgesic requirement, the stapled group had a significantly better pain score (P = 0.002); these patients also had a significantly shorter length of stay (P = 0.02), and on average resumed work nine days earlier than the group treated with the Harmonic Scalpel (6.7 vs. 15.6, P = 0.002). Although 88 percent of doughnuts obtained in the stapled group contained some smooth muscle fibers, no association was found between smooth muscle incorporation and postoperative continence function, and as a whole the continence outcomes of the stapled group were similar to those after Harmonic Scalpel hemorrhoidectomy. Finally, at six-month follow-up, patients who underwent the stapled procedure had significantly better satisfaction scores (P = 0.001).
                Stapled hemorrhoidopexy is a safe and effective procedure for Grade III hemorrhoidal disease. Patients derive greater short-term benefits of reduced pain, shorter length of stay, and earlier resumption to work. Long-term follow-up is necessary to determine whether these initial results are lasting. The aim of the study was to compare the results in 95 patients randomly allocated to undergo either stapled or open hemorrhoidectomy using Ligasure.
                Ninety-five patients with grade III and IV hemorrhoids were randomly allocated to undergo either stapled (50 patients) or open using Ligasure (45 patients). Stapled hemorrhoidectomy was performed with the use of a circular stapling device. Open hemorrhoidectomy was accomplished according to the Milligan-Morgan technique by using Ligasure. Postoperative pain was assessed by means of a visual analog scale (VAS). Recovery evaluation included return to pain-free defecation and normal activities. A 6-month clinical follow-up and an 18 (12-24) month median telephone follow-up were obtained in all patients.
                Operation time for open hemorrhoidectomy using Ligasure was shorter [median 13 (range 9.2-16.1) min vs 15 (range 8-17) minutes, p < 0.05]. Median range of VAS score in the stapled group were significantly lower [VAS score after 8 h: 3 (2-6) vs 5 (3-8), p < 0.01; VAS score after first defecation: 5 (3-8) vs 7 (3-9), p < 0.001. The stapled hemorrhoidectomy was associated with an increased incidence of intraoperative bleeding in 18 cases (36%) vs four cases (8.8%) of the Ligasure group. There were three cases (6%) from the stapled group with recurrence of the hemorrhoids and none from the open technique.
                Hemorrhoidectomy with a circular stapler device is easy to perform, but one more line of clips must be added to the device to avoid intraoperative bleeding from the cut line. Hemorrhoidectomy performed using Ligasure is more painful postoperatively but is a more radical operation.
Stapled hemorrhoidopexy is associated with a higher long-term risk of hemorrhoid recurrence and the symptom of prolapse. It is also associated with a higher likelihood of long-term symptom recurrence and the need for additional operations compared to conventional excisional hemorrhoid surgeries. Patients should be informed of these risks when being offered the stapled hemorrhoidopexy as surgical therapy. If hemorrhoid recurrence and prolapse are the most important clinical outcomes, then conventional excisional surgery remains the "gold standard" in the surgical treatment of internal hemorrhoids.