Haemorrhoidal stapler prolassectomy versus Milligan Morgan haemorrhoidectomy

International Journal of Colorectal Disease
Clinical and Molecular Gastroenterology and Surgery
© Springer-Verlag 2003
10.1007/s00384-003-0547-3

Original Article

Hemorrhoidal stapler prolapsectomy vs. Milligan-Morgan hemorrhoidectomy: a long-term randomized trial
A. Racalbuto1, 2 , I. Aliotta1, G. Corsaro1, R. Lanteri1, A. Di Cataldo1 and A. Licata1

(1) Department of Surgical Sciences, Organ Transplant and Advanced Technologies, O.U. General Surgery, Catania University, Catania, Italy
(2) Via Soldato Mannino 41, 95037 San Giovanni La Punta, Italy

Abstract
Background and aims 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.
Patients and methods 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).
Results 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.
Conclusion 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.
Keywords Hemorrhoidal prolapse – Stapler hemorrhoidectomy – Long-term randomized trial

Introduction
Hemorrhoidal prolapsectomy using a stapler has doubtedly radically changed the surgical treatment of hemorrhoids both conceptually and in practice. After earlier studies without controls, two excellent randomized studies were published in 2000, one by Rowsell et al. [1] and the other by Mehigan et al. [2], who in a short-term follow-up study compared the circular stapled procedure, namely the Longo operation, and the current standard procedure of Milligan-Morgan hemorrhoidectomy, with particular regard to pain symptoms. They concluded that the stapled procedure for hemorrhoids is associated with a significant improvement in postoperative pain control and with an earlier return to normal activity. Fazio [3] concluded that, the data available on stapled hemorrhoidectomy indicate that the procedure looks promising. Other important papers were published the same and following years [4, 5], but not all judgements have been favorable [6, 7, 8]. Moreover, the data required concern not only the symptoms of pain in the immediate postoperative period, but also functional results, complications, and of course the possibility of relapse over the long term. Only a longer follow-up would provide such data on the validity of the technique. Our randomized study with a long follow-up period of 48 months was directed at this goal.

Patients and methods
The study included 100 patients with 3rd and 4th degree hemorrhoids operated on between June 1998 and May 1999 and follow-up extended until May 2003. The investigation was approved by our local ethics committee. After providing written informed consent the patients were randomly divided into two groups by the selection of sealed envelopes. One group of 50 patients (31 men, 19 women; mean age 48.16 years, range 25–66) were operated on using the Longo circular stapler (stapled prolapsectomy, SP), and the other group of 50 patients (25 men, 25 women; mean age 44.04 years, range 26–71) received traditional Milligan-Morgan hemorrhoidectomy (MMH). Patients main symptoms were bleeding and prolapse (3rd degree in 70%, 4th degree in 30%). Patients with thrombosed hemorrhoids, partial prolapse (only one nodule), or perianal fistulas were excluded from the study. The presence of chronic associated fissures also excluded patients from the study. Nevertheless, in more recent cases of fissures associated with hemorrhoids admitted after the end of the present study we performed SP, completing the operation with a left sphincterotomy.

Before surgery the patients underwent fecal incontinence testing (Continence Grading Scale, CGS) [9] and continence evaluation by anorectal manometry. These examinations were repeated 1 and 12 months after the operation and at the end of the follow-up period (48 months).

Operation
As antibiotic prophylaxis we used a single 1-g dose of cefatriaxone 2 h before the operation, repeated only once 24 h after the first administration. The patients operating position was lithotomic in both operations. The technique used was either MMH or SP, decided randomly at the moment of operation by choosing one of two sealed envelopes of equal size and color. MMH as modified at St. Marks Hospital was rigorously followed, namely the exeresis of the hemorrhoidal piles upon low ligature of each vascular pedicle, sutured using absorbable material while safeguarding the mucous-cutaneous bridges. In SP the first step was to place the purse-string (Prolene 2/0, Ethicon) 3–4 cm above the dentate line using a circular anal dilator CAD 33 and the fenestrated anoscope of the special PPH kit (Ethicon). In three cases excessive prolapse required the use of a second string. We took great care to ensure that sutures pierced only the mucous membrane and the submucosa, avoiding damage to the underlying muscular layer. The stapler (CDH 33), opened to the maximum and well lubricated, was then introduced. Tilting the stapler slightly it was possible to knot the purse-string and check the reduction in the rectal mucous membrane over its entire circumference. The stapler was then closed slowly, taking particular care to make sure that the neither mucous membrane below the dentate line nor, in women, the posterior vagina wall were in the mechanical jaws. Having closed the stapler completely, we usually waited 60 s before stapling to ensure better hemostasis. For the same reason we waited a further 60 s before opening the stapler and gently removing it. Maintaining the CAD 33 in place, we checked the integrity of the metal staple suture line over the entire circumference. Any bleeding was halted using absorbable hemostatic sutures. In the case of incomplete reduction of the hemorrhoidal prolapse, it is possible to immediately staple a second time, although this was not necessary in the present study. The alvus was left open to stool and laxatives were prescribed (lactitol monohydrate for at least 7 days). The mean duration of each type of operation was calculated.

The type of anesthesia was almost entirely homogeneous. In the great majority of cases a mixed technique was employed in both types of operation using a hypnogenic such as propofol (Diprivan) together with local anesthesia by infiltration of 20 ml carbocaine 2% and 1:200,000 adrenaline. In 10% of cases we practiced general anesthesia with oral-tracheal intubation. Peridural saddle anesthesia was used in only 5% of cases. Regarding analgesia in the immediate postoperative period, the prolonged effect of local anal infiltration of carbocaine was exploited in patients who had received local anesthesia. Further, 1 mg/kg keterolac was always administered intravenously during the operation and, on request, in the hours immediately following the operation. On the first day after operation and in the days following discharge from the hospital ketorolac tablets were prescribed only on request of the patients in pain. The number of analgesic tablets taken by each patient was recorded.

Patients were followed up at 7 days, 15 days, and 1 month in the immediate postoperative period, then at 12 months, with a final long-term check-up at 48 months. In examinations in the immediate postoperative period, patients were asked about: (a) the presence or absence pain from the 1st day after operation and its continuation over the following days, quantified by the number of analgesic tablets used, (b) the moment of return to normal activity, working or domestic, (c) the degree of satisfaction in terms of alleviation of preoperative symptoms (on a scale of 1–10), (d) the degree and/or frequency (Wexner scale) of any fecal incontinence, and (e) the degree (Wexner scale) of any outlet obstruction. At middle- and long-term follow-up (12 and 48 months), patients were asked about: (a) Any relapse (recurrence) of the prolapse, (b) any recurrence of bleeding, (c) the degree and/or frequency (Wexner scale) of any fecal incontinence, and (d) the degree (Wexner scale) of any outlet obstruction. Manometric examinations (Polygram Medtronic) were carried out in the early postoperative period (within 1 month), at 12 months, and at the end of the follow-up period at 48 months. Digital examinations and anoscopy were performed to detect any possible stenosis.

Statistical analysis
Students t test was used to compare the results of the two groups and to compare pre- and postoperative paired data.

Results
Perioperative and early postoperative period (within 1 month)
No significant differences were found in the duration of the operation between the SP group (19.36±3.89 min, range 15–45) and the MMH group (22.78±1.99 min, range 10-45; (P=0.164). Significantly longer operating time was noted with SP technique only in particular cases, usually due to difficulty in setting up the purse-string or for hemostatic problems at the end of the operation. However, the same was true with the traditional operation for a variety of causes.

Mean length of hospitalization, calculated as the number of nights of admission, also did not differ significantly between the two techniques (SP 2.12±0.26 vs. MMH 2.34±2.44 days; P=0.098). In nearly all operations patients of both groups were discharged from the hospital after 2 nights, irrespective of any complications except the most severe. It should be noted that for reasons detailed below, we have not yet taken advantage of the opportunity offered by the SP technique to adopt day-surgery procedures, which would certainly make a significant difference, allowing the rapid discharge of those patients with minimal or no pain symptoms. On the other hand, prolonged hospitalization was necessary only in a few particular cases.

The presence of pain was the most significant parameter differentiating the two techniques. SP was clearly advantageous, with 47 patients (97%) reporting a total absence or only moderate degree of pain in the postoperative period (pain requiring only one or two analgesics in the immediate postoperative period was considered moderate). The mean consumption of analgesic for these patients was 1.30 tablets. Three patients (6%) complained of acute pain requiring serious and prolonged analgesic therapy with large dose of analgesics. Two took analgesics twice a day for 10 days for a total of 20 tablets each, and the third required two analgesics a day for 15 days for a total of 30 tablets. The possible causes of this are discussed below. Including these cases of acute pain the mean consumption of analgesic tablets for all patients in the SP group was 2.60 tablets. Pain was present in MMH patients for a total period varying from 7 days to 1 month, with a mean of 15.9 analgesic tablets per patient (P<0.0001) Consequently the return to working activity (including domestic) was more rapid in the SP group (mean 8.04±1.37 days, range 2–16) than in the MMH (mean 16.9±2.50 days, range 10–40; P<0.0001).

Early results
Complications (other than pain)

In the MMH group there was edema of the residual skin tags and/or of the mucous bridges in ten patients, acute urine retention in two, and massive bleeding in one who required a second operation a few hours after the first.

In the SP group there was congestion and perianal edema in ten patients, acute urine retention in one, and hematoma under the mucosa in one (case already described above). Massive bleeding on the same day as the operation or during the night immediately following was found in three patients (6%). The first case required surgical exploration while in the subsequent two cases we adopted an emergency technique, described below, to arrest the bleeding. No massive bleeding occurred in the short term (within 7–10 days from the operation). Modest bleeding was found in two cases observed between 15 and 30 days after the operation. This were considered probably due to the traumatic detachment of the metal clips on the passage of particularly hard feces. Questioned as to their degree of satisfaction (on a scale of 1–10) with the operation and its effects 1 month after the operation, patients in the MMH group reported a mean score of 6.46 and those in the SP group mean score of 7.88 (P<0.0001).

Functional results

In the MMH group five patients showed difficulty in controlling liquid stool, and four had difficulty in defecation (outlet obstruction), which was very severe in one woman. The mean Wexner incontinence score was 0.36 before operation and 0.50 after 1 month (P=0.24). The mean Wexner outlet obstruction score was 7.58 before operation and 9.38 1 month after (P=0.067). There were no significant differences on anal manometry before and after surgery. Mean basal pressure values of anal sphincter were 78.4±13.2 mmHg before the operation and 74.5±13.8 mmHg 1 month after the operation (P=0.148). The mean maximal squeeze pressure was 102.0±16.8 mmHg before the operation and 98.0±13.0 1 month after the operation (P=0.16).

In the SP group four patients experienced some form of minor incontinence (mainly urgency) immediately after operation and three had difficulty in defecation. The mean Wexner incontinence score was 0.40 before operation and 0.542 1 month after (P=0.25). The mean Wexner outlet obstruction score was 7.80 before operation and 8.54 1 month after (P=0.49). Also in this group there was no statistically significant difference between pre- and postoperative manometric values. Mean basal pressure values of anal sphincter were 83.8±14.8 before the operation and 79.0±12.7 after 1 month (P=0.082). The mean maximal squeeze pressure (expression of the striated sphincter functionality) was 108±23.7 before the operation and 99.6±21.4 1 month after operation (P=0.068).

Midterm results (12 months)
Complications

In the MMH group no fistulas, stenosis, or symptomatic skin tags were observed. Anal fissures were observed in two patients operated on again by left internal sphincterotomy. Pain at defecation of only modest intensity was reported by the 20% of the patients and anal itching by 30%. In the SP group a recurrence of complete prolapse was observed in two patients (4%), both men, at 6 and 8 months, and partial slipping of the mucous membrane in four women. Three patients had anal fissures at, respectively, 5, 6, and 9 months after the operation and, as with the patients of the MMH group with the same problem, they were operated on again by left internal sphincterotomy.

Functional results

In the MMH group three patients complained of urgency for liquid stool and four of some difficult in defecation. The mean Wexner incontinence score was 0.440 1 year after operation. The difference from the preoperative value was not significant (P=0.48). The mean Wexner outlet obstruction score was 7.92 1 year after operation (P=0.71). The mean basal anal pressure values (74.6±13.1, P=0.17) and the mean maximal squeeze pressures values (98.9±13.3, P=0.27) 12 months after the operation did not differ significantly from preoperative pressures.

In the SP group urgency persisted in three patients and outlet obstruction in other three. Neither the mean Wexner incontinence score (0.472 after 12 months, P=0.48) nor the mean outlet obstruction score (7.98 after 1 year, P=0.86) differed significantly from preoperative values. Mean basal pressure values of the anal sphincter (80.3±11.8 12 months after, P=0.20) were not significantly different from preoperative values. The mean maximal squeeze pressure was 99.7±18.2 12 months after (P=0.056), a quantitative confirmation of the generally good results of the continence test.

Long-term results (48 months)
This represents the more interesting aspect of the present study because it is the least mentioned in the literature on SP. In the MMH group no fistulas, stenosis, symptomatic skin tags, or anal fissures were observed 48 months after the operation. Few patients (n=8) presented modest sporadic bleeding with defecation, but these were patients who had unresolved problems of obstructed defecation and/or the formation of fecalomas after the operation. No relapse of the mucosa has been observed at longer times from the operation. We did not observe any cases of organic stenosis of the anus at the end of the follow-up. This excellent result is probably associated with our procedure of subjecting patients to rigorous postoperative checks with immediate digital or instrumental (Sapimed) anal dilation if any anal retraction was detected, together with a strict high-fiber diet. The long-term functional results at 48 months did not show significant differences between before and after operation by MMH. The mean Wexner incontinence score was 0.360 before the operation and 0.480 after 48 months (P=0.30), but three patients complained of urgency with occasional incontinence to gas and liquid stool. The mean Wexner outlet obstruction score was 7.58 before the operation and 7.90 after 48 months (P=0.74) with improvement after operation in the 10% of the patients but with worsening in some patients with good defecation before operation (8%). The manometric values in the long term (48 months) did not differ significantly from preoperative values regarding mean basal pressure (76.1±13.3, P=0.41) or mean maximal squeeze pressure (95.0±17.3, P=0.12).

In the SP group no stenosis was found 48 months after the operation. No other new cases of prolapse were reported except the two observed at midterm follow-up (4%). Only three patients complained of rare and modest bleeding upon defecation, probably due to the same factor as in the MMH group (obstructed defecation, fecalomas). With regard to the functional aspect of the SP group we paid particular attention to the possibility of reduced continence resulting from the use of the anal dilator in the stapler technique. No significant differences were found between patient continence (mean Wexner scale) before the operation and that 48 months after (0.400 before vs. 0.438 after, P=0.74) except in three cases in which patients reported urgency after the operation, with occasional incontinence to gas and liquid stool (Wexner score 4). The results of manometry measurements at 48 months (mean basal pressure 82.1±11.5, P=0.52; mean maximal squeeze pressure 101.0±16.7, P=0.11) did not differ significantly from preoperative values. In three patients symptoms of outlet obstruction persisted. At 48 months rectoanal sensitivity, tested by volumetric balloon, was within normal limits in all except two patients.

Discussion and conclusions
Undoubtedly the conventional techniques of ligature-excision of hemorrhoidal piles, of which MMH still remains the most commonly used throughout the world, have long represented the gold standard in the treatment of 3rd and 4th degree prolapsed hemorrhoids. They constitute an advance over more dated methods which, as a result of their coarseness and painful postoperative period, did much to earn hemorrhoidectomy an aura of terror and to relegate it to a place among the more neglected operations. Credit is therefore still due to MMH and similar techniques, but attention must now be given to hemorrhoidal prolapsectomy with circular stapler which both conceptually and technically is revolutionary and may be able to supplant traditional techniques. The SP technique has shown significant advantages over MMH for patients both in the immediate postoperative period and in the short term. Our experience confirms that of other researchers who have found benefits in terms of reduced pain and rapid return to work.

No significant difference was observed in the length of the operation (the stapler operation taking an average of only 4 min less, except in exceptional cases) and little difference regarding the incidence of early complications, above all perianal edema and congestion of skin tags, of negligible practical interest, however. Severe postoperative pain was rare in the stapled group. In one patient, the very first to be treated, pain was due to a hematoma under the mucosa at the line of suture. The pain ended suddenly when 10 days after the operation we drained the hematoma by incision under local anesthesia. In the other two patients the cause was a technical error: the purse-string sutures were placed too close to the dentate line, resulting in the accidental stapling of the sensitive anoderm. However, the pain ended 15–20 days after operation when the metal clips began to detach spontaneously from the anal mucosa or were removed surgically through the anus. In our study there was no persistent pain at the percentages (31%) or length (up to 15 months) as reported by other authors [10].

Another problematic aspect of the new technique which must be mentioned is the danger of massive bleeding in the immediate postoperative period, reported in many studies, although fortunately of modest incidence overall (5–6%). The fact is that such hemorrhagic incidents, probably due to imperfect hemostasis of the metal clips (defective closing of the stapler related to thickness of the tissue?), are insidious, and their weight is excessive for this type of operation. In our study there were three such cases. As in every operation, hemostasis was cautiously confirmed at the end of the operation, checking the entire suture circumference, and applying additional hemostatic stitches when necessary. The hemorrhages had a deceptive onset, with a slow but continuous loss of blood which accumulated in large quantities in the rectal ampulla before being evidenced by violent hematic discharges from the anus, symptoms of lipothymia, and rapid fall in hemochrome. In the first case we returned the patient to the operating theater during the night, and exploration of the anal channel and rectum and also endoscopic examination of the rest of the colon revealed a large quantity of coagulated blood as far as the cecum. The circular suture of the stapler gave no signs of further bleeding, as though this had stopped spontaneously. As a result of this experience in the two subsequent cases we stopped the bleeding using a Foley catheter, with the balloon inflated to the maximum. This was placed in the anal canal above the zone of bleeding, corresponding to the circular suture of metal clips, and put under traction by means of external weights. The compression was maintained for several hours (up to 6 h) sufficient to halt the hemorrhage completely and permanently. In proportional terms the occurrence of this complication was modest (5%), but the severity and inherent danger of the clinical picture has made us cautious. This is the main reason why, as mentioned above, we have not yet performed this type of operation in day-surgery.

Of the two cases of recurrent prolapse in the SP group, one patient refused a second operation while a new operation with stapler resolved the problem in the second, a patient with relapse at 6 months, and the final check-up at 48 months confirmed the positive outcome. Compared to the MMH group, this incidence of recurrence (8.5%) was not significant (P=0.16). However, for the aims of this study, the results and evaluations at 48-month follow-up are of greater interest. The MMH results were good, as was to be expected from the numerous follow-up reports in the literature, including a study on 52 patients published by the authors some 10 years ago [11]. Now as then, long-term monitoring (48 months) has not shown recurrence of hemorrhoidal prolapse or bleeding of note, although severe constipation persists in 10–15%, hyperemia and itching in 15%, and sphincter hypertonia and pain, also of considerable intensity, in 10%. Two patients (5.7%) were reoperated on for anal fissures, one 5 and one 8 months after the first operation.

MMH is a technique that undoubtedly allows the complete cure of hemorrhoids. The possible sequelae are overall of modest degree and incidence, and the result of unpredictable thrombosis phenomena depending on the venous plexuses of the mucous-cutaneous bridges or of sphincter hypertonia with inflammation of the anoderm. Such inflammatory phenomena, however, are also associated with an inadequate treatment of postoperative constipation. Finally, we have never found stenosis a long time after MMH, also because we carefully monitor the scarring process for at least 1 month after the operation, with digital exploration (and if necessary dilation) at 7 days, 15 days, and 1 month from the operation, and guide the process with a fiber-rich diet.

Known functional complications, which are also possible after traditional hemorrhoidectomy and are probably due to iatrogenic disruption of anal sphincter muscle fibers, have been investigated by many authors. These have demonstrated the possibility of a significant reduction in basal anal pressure and squeezing compared to preoperative values, with the corresponding clinical symptoms of minor incontinence (defecation urgency, difficulty in controlling gas and liquid stool). In our experience, however, postoperative manometry values show no significant changes after at long-term follow-up of 48 months. In SP the long-term follow-up results obtained here are of great interest given their absence in the literature. In particular, the long-term effectiveness of SP must be evaluated in terms of any recurrence of the prolapse and/or of bleeding as well as the manifestation of any organic complications such as a stenosis and possible permanent functional damage to the external anal sphincter. The results obtained in our follow-up at 48 months indicate:
– No recurrence of total prolapse, except that of two patients in the early postoperative period.
– No recurrence of bleeding long after the operation, except the rare episodes of modest intensity and brief duration discussed above. This confirmed the long-term effectiveness in nearly all patients of one of the cornerstones of the technique, namely the interruption of the blood supply to the hemorrhoidal venous plexuses through circular anastomosis-section.
– No long-term stenosis was found in patients operated on with this technique, as in the MMH group. Again, outpatient monitoring included digital exploration and, if necessary, moderate dilation.
– Two patients complained of fissures, respectively, 6 and 8 months after the operation. It is unclear whether this was due to erroneous preoperative diagnosis or to a postoperative complication.
– With regard to functional outcome we found only three cases of permanent minor incontinence which could be considered as defecation urgency. In our opinion this was due to excessive dilatation provoked by the large dilator and the consequent stretching of the muscle. We observed no instance of muscle fibers being included in the stapler, which has been indicated as a possible cause of incontinence by some authors.
– With regards particularly to difficulty in defecation (outlet obstruction) the data obtained were discordant and inconclusive. Difficulty was reported by 30% of the patients before operation, with some improvement after the operation (10% with MMH, 6% with SP). Conversely, some patients with good defecation before the operation had difficulty after (8% with MMH, 6% with SP).
In conclusion, the results of SP in our experience not only confirm the excellent benefits of the new technique in the immediate postoperative period (88% of patients had a perfect postoperative period with a higher mean score of satisfaction and a more rapid recovery respect the MMH), but also demonstrate the complete long-term (at 48 months) recovery from hemorrhoidal pathology, in terms of recurrence (96%) and bleeding (94%), for the great majority of patients. These results are congruent with those of the MMH operation. Moreover, monitoring detected no case of stenosis, and the functional study demonstrated that using the stapler does not entail significant risk of permanent damage to the anal sphincter (only 6% of mild incontinence at 48 months). We can therefore consider that the technique is close to being confirmed as the new gold standard in the radical treatment of prolapsed hemorrhoids, if used correctly and with appropriate patient selection. It is now necessary to gather more positive data and to resolve the remaining problem of massive bleeding in the immediate postoperative period by refinement of the procedure.

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