A prospective, randomized, controlled multicenter trial comparing stapled hemorrhoidopexy and Ferguson hemorrhoidectomy: perioperative and one-year results. Stapled hemorrhoidopexy vs. diathermy excision for fourth-degree hemorrhoids: a randomized, clinical trial and review of the literature. Stapled hemorrhoidopexy versus milligan-morgan hemorrhoidectomy: a prospective, randomized, multicenter trial with 2-year postoperative follow up. Randomized comparison between stapled hemorrhoidopexy and Ferguson hemorrhoidectomy for grade III hemorrhoids in Taiwan: a prospective study. Stapled hemorrhoidopexy vs. Harmonic Scalpel hemorrhoidectomy: a randomized trial. Day-case stapled (circular) vs. diathermy hemorrhoidectomy: a randomized, controlled trial evaluating surgical and functional outcome. Randomised controlled trial between stapled circumferential mucosectomy and conventional circular hemorrhoidectomy in advanced hemorrhoids with external mucosal prolapse. Hemorrhoidal stapler prolapsectomy vs. Milligan-Morgan hemorrhoidectomy: a long-term randomized trial. Stapled vs excision hemorrhoidectomy: long-term results of a prospective randomized trial. Long-term results after excision haemorrhoidectomy versus stapled haemorrhoidopexy for prolapsing haemorrhoids; a Belgian prospective randomized trial. Flavonoids to reduce bleeding and pain after stapled hemorrhoidopexy: a randomized controlled trial.
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. 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. The purpose of this study was to compare the outcome of stapled hemorrhoidopexy (SH group) performed using a circular stapler with that of the Milligan-Morgan technique (MM group). The goals of the study were to evaluate the efficacy and reproducibility of stapled hemorrhoidopexy and define its place among conventional techniques.
                A series of 134 patients were included at 7 hospital centers. They were randomized according to a single-masked design and stratified by center (with balancing every 4 patients). Patients were clinically evaluated preoperatively and at 6 weeks, 1 year, and a minimum of 2 years after treatment. Patients completed a questionnaire before and 1 year after surgery to evaluate symptoms, function, and overall satisfaction.
                The mean follow-up period was 2.21 years +/- 0.26 (1.89-3.07). Nine patients (7%) could not be monitored at 1 or 2 years, but 4 of these 9 nevertheless filled in the 1-year questionnaire. The patients in the SH group experienced less postoperative pain/discomfort as scored by pain during bowel movement (P < 0.001), total analgesic requirement over the first 3 days (according to the World Health Organization [WHO] class II analgesics [P = 0.002]; class III [P = 0.066]), and per-patient consumption frequency of class III analgesics (P = 0.089). A clear difference in morphine requirement became evident after 24 hours (P = 0.010). Hospital stay was significantly shorter in the SH group (SH 2.2 +/- 1.2 [0; 5.0] versus MM 3.1 +/- 1.7 [1; 8.0] P < 0.001). At 1 year, no differences in the resolution of symptoms were observed between the 2 groups, and over 2 years, the overall incidence of complications was the same, specifically fecaloma (P = 0.003) in the MM group and external hemorrhoidal thrombosis (P = 0.006) in the SH group. Impaired sphincter function was observed at 1 year with no significant difference between the groups for urgency (12%), continence problems (10%), or tenesmus (3%). No patient needed a second procedure for recurrence within 2 years, although partial residual prolapse was detected in 4 SH patients (7.5%) versus 1 MM patient (1.8%) (P = 0.194).
                Stapled hemorrhoidopexy causes significantly less postoperative pain. The technique is reproducible and can achieve comparable outcomes as those of the MM technique as long as the well-described steps of the technique are followed. Like with conventional surgery, anorectal dysfunction can occur after stapled hemorrhoidopexy in some patients. Its effectiveness in relieving symptoms is equivalent to conventional surgery, and the number of hemorrhoidal prolapse recurrences at 2 years is not significantly different. Hemorroidopexy is applicable for treating reducible hemorrhoidal prolapse. 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. 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. Stapled hemorrhoidectomy may be associated with less pain and faster recovery than conventional hemorrhoidectomy for prolapsing hemorrhoids. Therefore, the outcome of stapled hemorrhoidectomy was compared with that of diathermy hemorrhoidectomy in a randomized, controlled trial.
                Sixty patients with third-degree hemorrhoids were randomly assigned to stapled hemorrhoidectomy (n = 30) or to diathermy hemorrhoidectomy in a day-case setting. Visual analog scale was used for postoperative pain scoring. Surgical and functional outcome was assessed at six weeks and one year after surgery.
                Operation time was a median of 21 (range, 11-59) minutes in the stapled group. 22 (range, 14-40) minutes in the diathermy group. Day-case surgery was successful in 24 patients (80 percent) in the stapled group vs. 29 patients (97 percent) in the diathermy group. Average pain in the stapled group was significantly lower than in the diathermy group (median, 1.8 (0.1-4.8) vs. 4.3 (1.4-6.2), 95 percent confidence interval difference medians, 1.15-3.85, P = 0.0002, Mann-Whitney U test) as was the average pain expected by the patients (median -2.7 (-0.15-0.8) vs. 0.006 (-4.05-0.5) respectively, 95 percent confidence interval difference medians, 0.5-3.55, P = 0.0018, Mann-Whitney U test). Postoperative morbidity and time off work were not significantly different between the diathermy and stapled groups. Seven treatment failures in the stapled group and one in the diathermy group necessitated other treatments at a later date. Patient satisfaction scores in the stapled and diathermy group were similar. Symptoms attributed to difficult rectal evacuation decreased significantly after surgery.
                Stapled hemorrhoidectomy is a significantly less painful operation than diathermy hemorrhoidectomy, but does not seem to offer significant advantages in terms of hospital stay or symptom control in the long term. Hemorrhoidectomy may improve symptoms of difficult rectal evacuation. This randomized prospective study compared the outcome of circular hemorrhoidectomy according to the Hospital Leopold Bellan (HLB) technique (Paris) with Longo stapled circumferential mucosectomy (LSCM) in two homogeneous groups of patients affected by circular fourth-degree hemorrhoids with external mucosal prolapse.
                From December 1996 to December 1999, 80 consecutive patients with fourth-degree hemorrhoids and external mucosal prolapse were randomly assigned to two groups. Forty patients (group A: 18 men, 22 women, mean age 50.5 years, range 21 to 82) underwent HLB hemorrhoidectomy, and 40 patients (group B: 15 men, 25 women, mean age 51.0 years, range 29 to 92) underwent LSCM. Before surgery, all patients were selected with a standard questionnaire for symptom evaluation, full proctological examination, flexible rectosigmoidoscopy, dynamic defecography, and anorectal manometry. No significant differences among the two groups were found. All patients were controlled with follow-up questionnaire and with clinical examination at 1, 2, 4, 12, and 54 weeks after the operation. A postoperative manometry was performed 3 months after surgery.
                The length of the operation was significantly lower in group B (25 +/- 3.1 SD versus 50 +/- 5.3 minutes, P <0.001). Mean hospital stay was 3 +/- 0.4 days in group A and 2 +/- 0.5 days in group B (P <0.01). Mean duration of inability to work was 8 +/- 0.9 days in group B and 15 +/- 1.4 days in group A (P <0.001). Postoperative pain was significantly lower in group B (P <0.001). Mean length of follow-up was 20 +/- 8.0 months in group A and 20 +/- 7.8 months in group B. Late complications were similar in the two groups, with 0%, at present, recurrence rate.
                Our results confirm that both operations are safe, easy to perform, and effective in the treatment of advanced hemorrhoids with external mucosal prolapse. However, the LSCM seems to be preferable owing to the fewer postoperative complications, easier postoperative management, and shorter time to return to work. A longer follow-up is required to confirm the true efficacy of this surgical method. 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. Stapled hemorrhoidectomy offers several advantages over excision hemorrhoidectomy, including reduced postoperative pain, a reduced hospital stay, and an earlier recovery time. Furthermore, stapled hemorrhoidectomy is associated with lower hemorrhoidal recurrence on long-term follow-up.
                A randomized prospective trial. Patients were blinded to the operation technique used. Follow-up occurred at 1 and 3 weeks and 12 months postoperatively.
                A university hospital providing primary, secondary, and tertiary care.
                Forty patients with second- and third-degree hemorrhoid disease were randomized to undergo either stapled or excision hemorrhoidectomy. Two patients were excluded. All patients were subject to a follow-up examination.
                Stapled hemorrhoidectomy (Longo technique) vs excision hemorrhoidectomy (Ferguson technique).
                Operating time, postoperative pain (measured by the visual analog scale), hospital stay, histologic features, morbidity, defecation habit, continence, recovery time (return to work), and hemorrhoid recurrence at 1 year.
                Stapled vs excision hemorrhoidectomy was associated with a significantly reduced operating time (30 vs 43.25 minutes; P<.001), reduced postoperative pain scores (visual analog score) on the first 4 postoperative days (day 1: 2.7 vs 6.3; day 2: 1.7 vs 6.3; day 3: 0.8 vs 5.4; and day 4: 0.5 vs 4.8, where 0 indicates no pain, and 10, maximum pain; P < or = .001), and an earlier return to work (6.7 vs 20.7 days;P =.001). There were no differences for stapled vs excision hemorrhoidectomy in length of hospital stay (2.4 vs 2.1 days), complications (3 [15%] of 20 patients vs 5 [25%] of 20 patients), and recurrence rate (1 [5%] of 20 patients vs 1 [5%] of 20 patients).
                Stapled hemorrhoidectomy is associated with reduced postoperative pain, earlier recovery time and return to work, and a similar recurrence rate compared with the excision technique. Provided further clinical trials confirm these findings, stapled hemorrhoidectomy may become a future gold standard. 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. 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.
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.