PPH: To Staple or Not to Staple: That is the Question

INTRODUCTION

Symptomatic internal and external hemorrhoids present with some of the most vexing problems known to mankind and to surgeons. Each year, over 525,000 patients are treated for symptoms associated with hemorrhoids. (1) Of these, 10-20% ultimately require surgical treatment.

Watch this brief video of Hemorrhoid Treatment Options Explained by Dr. Hoffman:

Until recently, the surgical treatment of hemorrhoidal disease was often more debilitating than the problem itself. Surgical therapy has involved significant postoperative pain, with large blocks of time being spent away from work or the activities of daily living. There exists a natural reluctance on the part of an experienced surgeon to replace a proven, albeit painful operation with one that is new. This is particularly evident in the private practice setting. Should problems arise, the post operative course may become quite complicated, painful, and permanently debilitating. This reluctance is underscored when dealing with diseases of the anal canal

With the advent of modern surgical stapling techniques, the introduction of circular stapled hemorrhoidectomy (or stapled hemorrhoidopexy) has come to the forefront as a possible solution to this problem. In this discussion, we will briefly review hemorrhoidal anatomy and symptomatology as well as the various treatment options. We will discuss the technical details of the stapled hemorrhoidectomy and then evaluate our early results using this technique. Stapled hemorrhoidectomy will then be discussed and presented as an alternative to, and an improvement on traditional surgical procedures.

ANATOMY

Hemorrhoids are naturally occurring vascular cushions found in the anal canal. At birth, they are small and insignificant. However, with time, they enlarge. They may remain asymptomatic or may produce symptoms of varying degrees.

Traditionally, hemorrhoidal vasculature is found in the anal canal in the right anterior, right posterior, and left lateral positions. When located distal to the dentate line, hemorrhoids are considered to be external (although they may not be visible to the eye of the examiner). Proximal to the dentate line, hemorrhoids are considered to be internal. Fibers from the internal anal sphincter and conjoined longitudinal muscles anchor the submucosal plexus of hemorrhoids and serve to prevent prolapse of the plexus and overlying mucosa.

The main blood supply to hemorrhoids arises from the terminal branches of the superior hemorrhoidal artery. Middle and inferior hemorrhoidal arteries make lesser contributions to the hemorrhoidal plexus. There is a corresponding venous drainage. It is these veins, when enlarged, which constitute the bulk of the hemorrhoidal plexus. It should be emphasized that although this represents the traditional anatomy of the region, the true anatomy is much more variable and can be much more extensive. Hemorrhoidal veins can actually be much more numerous than the traditional grouping of three. Indeed, the hemorrhoidal plexus can actually be circumferential.

ETIOLOGY

No definite etiology has been proven to be the primary cause of symptomatic hemorrhoids. However, factors which seem to be associated with hemorrhoidal disease include constipation, prolonged straining at defecation, diarrhea, pregnancy, heredity, aging, internal sphincter abnormalities, and gravity. All members of the adult population have experienced one or more of these etiological associations at sometime during life, making an exact etiology of hemorrhoidal disease difficult to prove.

Hemorrhoidal disease is not more frequent in patients with portal hypertension. However, rectal varices do occur with portal hypertension and must be differentiated from hemorrhoidal disease, as management and treatment options differ significantly.

SYMPTOMS

Symptoms attributable to internal (and external) hemorrhoids include bleeding, hemorrhoidal protrusion, pain, mucous discharge, itching and/or a sensation of incomplete evacuation. It is important that other causes of these symptoms be ruled out prior to embarking on hemorrhoidal treatment. Anal pain must be differentiated from an anal fissure or a thrombotic external hemorrhoid. In appropriate patient populations, bleeding malignancies, as well as bleeding polyps must be searched for and treated. Many of the symptoms of ulcerative colitis or Crohn’s disease can present similar to symptoms associated with hemorrhoidal disease. A thorough search for inflammatory bowel disease must be performed, and any inflammatory conditions appropriately treated. Irritable bowel syndrome may present with a mucous discharge and should be investigated. If appropriate, stools, and possibly the perineum can be cultured to be sure that a bacterial, fungal or parasitic infestation is not the source of pruritus ani. Many patients use soap in an effort to maintain anal hygiene. Soap use (abuse) for cleaning can be most irritating to the skin. This should be stopped and a short course of topical hydrocortisone creams used to treat a soap irritation and the resulting pruritus.

CLASSIFICATION

Hemorrhoids are traditionally classified into four grades. Grade 1 is associated with hemorrhoids that protrude into the lumen of the anal canal. Grade 2 hemorrhoids protrude from the anal canal with bowel movement, and spontaneously reduce after the movement is completed. Grade 3 hemorrhoids protrude spontaneously from the anal canal (or with a bowel movement) and require manual reduction. Grade 4 hemorrhoids are associated with an irreducible prolapse. A clear differentiation must be made from true rectal procidentia.

It is important to note that any hemorrhoidal grade may be associated with symptoms, or may be asymptomatic. This point is important in planning treatment regimens for hemorrhoidal disease. Large hemorrhoids may be completely asymptomatic and thus require no treatment. Conversely, small hemorrhoids may be quite debilitating, causing patients to request curative treatment.

TREATMENT OPTIONS

Treatment options for symptomatic hemorrhoids are numerous and varied. They range from simple dietary modification with increased fiber intake and adequate fluid intake to surgical treatment. In between this range of options, patients may be treated with topical agents such as hydrocortisone creams, over-the-counter medicated preparations, sitz baths, leg elevation, and a variety of minimally invasive procedures.

Sclerotherapy (5% phenol in olive oil) has been a time-tested symptomatic remedy. Injections can be associated with immediate relief and are usually reserved for patients with minor bleeding, but may be used in patients who complain of mild fecal soiling or mucous discharge. Success rates vary, but sclerotherapy is most often only temporary.(2)

Infrared coagulation, laser therapy and cryotherapy have been used with greater and lesser degrees of success. These modalities depend upon the application of extremely high temperatures (or extremely cold temperatures) to the hemorrhoidal plexus in an effort to coagulate the blood supply and denature the protein in the hemorrhoidal plexus. Originally, it was thought that this would lead to obliteration of the hemorrhoids and the associated hemorrhoidal symptoms. However, these treatments have not been found to be associated with a high success rate.(3) Additionally, if used incorrectly, the post-treatment pain associated with these modalities can be debilitating and prolonged.

Rubber band ligation has been used with varying degrees of success in an attempt to remove individual hemorrhoidal groups. With or without an anesthetic agent, rubber bands (either a single band or double bands) are placed around the base of each hemorrhoidal pedicle. This produces vascular necrosis of all of the tissue beyond the rubber band. This modality has also met with varying degrees of success. It has an associated failure rate of between 20-30%.(4) Bands have been known to slough off in the early post-treatment period resulting in an incomplete treatment. Advantages of the rubber band technique include its use as an outpatient treatment and its ease of use. Sepsis is a rare but life threatening complication.(5-7)

Traditionally, surgical hemorrhoidectomy has been viewed as the definitive method in the treatment of symptomatic hemorrhoidal disease. Several techniques have been popularized (Millikin-Morgan, and Ferguson). In its most simple form, surgical hemorrhoidectomy removes all hemorrhoidal tissue (both internal and external) and, ideally returns patients to an asymptomatic lifestyle. It is well known that a surgical hemorrhoidectomy may be associated with an exquisitely painful postoperative experience, leading to a delayed return to work and to the activities of daily living. Additionally, surgical hemorrhoidectomy is associated with potential complications. These include anal stenosis, hemorrhoidal recurrence, (which may indeed simply be a failure to remove the entire hemorrhoidal vascular plexus at the time of the initial operation), and postoperative urinary retention or constipation. The first several bowel movements are usually extremely painful.

Despite these various treatment options, patients have been reluctant to seek help from their physicians. Surgeons have been reluctant to recommend definitive surgical therapy for their patients.

STAPLED HEMORRHOIDECTOMY

In 1991, Allegra discussed his use of a circular stapling device in the surgical treatment of symptomatic hemorrhoidal disease.(8) In 1998, Longo reported his modifications of Dr. Allergra’s technique. He reported his results in patient care using what he termed a stapled hemorrhoidopexy.(9) Although the procedure is commonly referred to as a stapled hemorrhoidectomy, it is actually an hemorrhoidopexy.

Briefly, stapled hemorrhoidectomy involves the excision of a ring of mucosa, submucosa and hemorrhoidal vasculature at a point four cm. proximal to the dentate line. Simultaneously, a mucosal anastomosis is performed with a 33 mm circular surgical stapler, applying a staggered double row of 28 titanium staples. This results in a repositioning of the vascular cushions to a more normal anatomic location within the anal canal (hemorrhoidopexy). Concurrent with this, the hemorrhoids are circumferentially devascularized. Over the course of several weeks, they will begin to shrink and involute.

Because the procedure is performed proximal to the dentate line, in a region devoid of pain fibers, stapled hemorrhoidectomy is associated with significantly less postoperative discomfort, and a more rapid to return to the activities of daily living. Visceral sensory fibers are found in the surgical area however, and this can give rise to a temporary sense of fullness (urinary or rectal) and an associated feeling of needing to empty the bladder or to defecate in the immediate post operative period.

It is significant to note that since the procedure was first popularized in Europe (Italy), the adoption of the procedure as a standard technique in the treatment of hemorrhoidal disease has spread from east to west. Over the course of the last five years, 300,000 stapled hemorrhoidectomies have been performed world wide (personal communication from Ethicon Endo-Surgery).

INDICATIONS

Stapled hemorrhoidectomy may be considered as the primary mode of treatment in any patient who, heretofore, would have been a candidate for a standard surgical hemorrhoidectomy. These indications typically include patients with grades 3 and 4 symptomatic hemorrhoids. Additionally, patients with grade 2 hemorrhoids who have had failures of other therapeutic modes may be considered as candidates for the procedure. Selected patients with grade 2 hemorrhoids, who have requested definitive treatment of their hemorrhoidal disease, also may be considered candidates for stapled hemorrhoidectomy. Patients with a rectal mucosal prolapse are also candidates for the procedure.

Absolute contraindications are few and include an anal canal that does not permit the insertion of the stapler, and patients with anorectal Crohn’s disease or ulcerative colitis. Stapled hemorrhoidectomy should not be performed while there exists an active anorectal abscess.

Relative contraindications include patients in whom previous hemorrhoidal operations or other operative procedures have left the patient with decreased sphincter tone or muscular disruption. Additionally, patients who have been anticoagulated must be evaluated closely. Stapled hemorrhoidal operations should be considered like any other operative procedure in these individuals. Therefore, patient overall physical and medical status must be evaluated prior to embarking definitive therapy.

THE PROCEDURE

It should be noted that the stapled hemorrhoidectomy can be technically challenging. There are numerous steps in this procedure which must be followed in order to avoid postoperative complications. We have found that two trained surgeons performing the procedure together lessen the likelihood of a surgical misadventure. One surgeon should be a colon and rectal specialist (by formal training or through focused experience). Similar proposals have been advocated by other authors as well.

The procedure is usually performed in the outpatient setting. It may be performed with any method of suitable anesthesia. Currently, our patients receive total intra-venous anesthesia and a local anal block. The procedure is most commonly performed in the prone jackknife position. It may be performed in the lithotomy position, however, the ergonomics make this a more difficult and cumbersome approach. The surgical time for this procedure can be as short as 15 minutes or as long as 45 minutes, and is dependent on surgeon experience and various other anatomical factors. These factors include the size and extent of the hemorrhoids, their friability, and the angulation of the anal canal. A preoperative cleansing enema is self-administered by the patient on the morning of the operation. Preoperative antibiotics are not mandatory and are left to the discretion of the surgeon.

Figure 1 shows an artistic rendering of the anal canal prior to beginning a stapled hemorrhoidectomy.

In the operating room, after the administration of an appropriate anesthetic, an anal block is administered using ¼% bupivicaine-without epinephrine. We then use the lubricated obturator to gently dilate the anal canal prior to inserting the circular anal dilator. The circular anal dilator and obturator are then inserted into the anal canal (figure 2). Once in position in the anal canal, the obturator is removed and the anal dilator is held in place with several sutures placed through the openings in the attached flange. (Alternatively, the first assistant can simply hold the anal dilator in place throughout the procedure). Care should be taken to make sure that the dentate line is protected by the circular anal dilator.

With the surgeon standing on the left side of the patient, the purse string anoscope is then inserted into the anal canal. The surgeon begins the purse string suture placement in the left anterior quadrant of the patient. The circumferential mucosal/submucosal purse-string suture is placed approximately 4 cm – 6 cm proximal to the dentate line (figure 3). We have found that the use of 2-0 Monocryl (Ethicon Endo-Surgery) on a UR-6 needle is our suture material of choice. The UR-6 needle facilitates ergonomic ease of placement of the purse string suture. In some patients, due to the posterior angulation of the anal canal, extra attention must be paid to placing the purse suture in the correct location when approaching the posterior wall of the rectum. It is possible to inadvertently continue placing the purse string suture into the anterior wall of the rectum while believing that the purse string suture is actually being placed in the posterior wall. Misapplication of the purse string can result in a surgical misadventure.

Once the purse string suture has been placed, the purse string anoscope is removed and a gloved finger is placed into the rectum and across the purse string suture. Each end of the purse string suture is gently pulled snug and the operating surgeon then determines that there are no gaps in the purse string. The surgeon should feel only mucosa and should not feel a bowstringed suture. If necessary, the purse string suture may be removed and placed again.

At this point, the hemorrhoidal stapler is opened to its maximal extent. The anvil is coated with water-soluble lubricant and placed into the rectum. It is carefully, and under direct vision, advanced proximal to the purse string. A gentle “popping” sensation is felt as the anvil traverses the purse string suture. This must be done gently and in line with the central axis of the anal canal. When it has been determined that the anvil is indeed located proximal to the purse string suture, the purse string suture is cinched closed around the center rod of the stapler. Visual and tactile inspection will ensure that the entire circumference of the anorectal mucosa is snug around the center rod. The purse string suture is then tied. The ends of the suture are now brought out through the side of the instrument using the purse string puller (figure 4).

The first assistant applies gentle outward traction on the purse string suture, while the surgeon gently pushes the instrument into the anal canal and closes the stapler jaws (figure 5). It is important to note that the sliding red bar in the staple height window (located on the body of the stapler) moves to the fully closed position. Gentle traction is maintained on the suture tails as the instrument is closed (figure 6).

In female patients, a gloved finger is then placed into the vagina to ascertain that the vaginal lining is free from the jaws of the closed stapler. The closed stapler is moved laterally in both directions and then proximally and distally. This movement of the stapler will help the surgeon to ensure that the rectovaginal septum in not incorporated between the anvil and chamber of the stapler.

The surgeon then removes the circular anal dilator and everts the perianal buttock skin. This important step is done to ensure that the dentate line is actually seen to be free from the jaws of the stapling device.

The stapler is fired and held closed for two or three minutes to aid in hemostasis. Finally, the stapler is opened, and removed and the staple line is visualized (figure 7).

Hemostasis is evaluated by placing the purse string anoscope back into the anorectum, and evaluating the staple line for bleeding. Any venous oozing can be controlled using electrocautery, and any arterial bleeding can be controlled with a 2-0 or 3-0 absorbable suture ligature. The staple line must be evaluated for its complete circumferential placement. Any gaps in the staple line can be over-sewn with 2-0 absorbable suture (proximal to the level of the dentate line).

Once again, in female patients, a bimanual examination of the rectovaginal septum is performed. Both fingers are moved in opposite directions to ensure that the mucosa of the rectum and the vagina move separately from each other and that there is no rectovaginal fistula present.

The stapler is opened to its maximum extent and the hemorrhoidal doughnut is carefully retrieved from the chamber of the stapler. It is evaluated to be sure that it is completely circumferential. An incomplete doughnut should alert the surgeon to a possible skip area or problem with the staple line, and the operative site should be re-evaluated. The specimen is evaluated for height and thickness. It is then sent to the pathologist with a request that all microscopic layers be described in the final pathology report.

Although we do not use packing or topical hemostatic agents, many surgeons do. An hemostatic agent such as oxidized cellulose may be placed into the anorectum. A light dressing is placed externally. Unless contraindicated, each patient is given intravenous and/or intramuscular ketoralac at the conclusion of the procedure. The operation is then concluded.

In the recovery room, patients may complain of rectal or urinary pressure or pain. They may feel the need to urinate or defecate even though they had given themselves a preoperative enema and had emptied their bladder. Additionally, each patient received a local field block in the operating room. Early in our experience we learned that intravenous narcotics did little to alleviate these uncomfortable sensations. We discovered that midozolam, given in one or two milligram boluses on an as needed basis in the recovery room allowed our patients to rest and then recover without these problems. We administer the midozolam when the patient begins to complain of a painful pressure sensation.

Patients have been advised preoperatively, and are reminded in the postoperative period to avoid straining at bowel movement. This increased valsalva effect can lead to postoperative bleeding. Patients are told that they may feel rectal pressure and the sensation of a need to defecate. This sensation will resolve in 24 to 48 hours. A light sedative on the first postoperative night will allow for a smooth transition into the postoperative period. Patients are told that the staples will slough in four to six weeks, and are advised that no anorectal sexual manipulation can occur for at least six weeks.

Post-operatively, patients are given a prescription for a narcotic analgesic to take on an as needed basis. Most often, this is not necessary. Unless contraindicated, patients are also given a prescription for ketorolac, 10 mg by mouth every six hours, for three days. Patients are instructed to take this on a regular basis until the prescription is finished. We prescribe preoperative and postoperative antibiotics in selected patients (those with cardiac valvular disease or other cardiovascular indications). As we have not had any cases of systemic or local perioperative infections, we are using antibiotics selectively. In our early experience, we routinely prescribed oral stool softeners. However, we found that this practice seemed to be associated with postoperative stool frequency. We also found that since the first bowel movement after the procedure was not necessarily uncomfortable, there no longer seemed to be a need for a postoperative oral bulking agent and we have discontinued this practice.

Patients are interviewed by telephone on the evening of the procedure and on the morning after the procedure. They are then seen in an office setting at one week, three weeks, one month, three months, six months, and one year postoperatively, and then on a yearly basis.

RESULTS

In 2002, in order to evaluate the safety and efficacy of this technique in the private practice setting, we evaluated our first 50 patients.

First and foremost, we found the procedure to be safe and free from all but the mildest of complications.

The average age of the patients undergoing stapled hemorrhoidectomy was 51 years. Gender was equally divided between males and females. One patient had symptomatic grade one hemorrhoids, five patients had grade 2 hemorrhoids, forty two patients had grade 3 hemorrhoids, and two patients had grade 4 hemorrhoids.

Symptoms included prolapse, bleeding, pruritus, pain and discharge. Ten patients had an associated anal fissure, one patient had a large anal papilla, seven patients had thrombotic hemorrhoids (both acute and chronic) and one patient had a superficial anal fistula.

Mean operating time was 32 minutes. It was our subjective opinion that we required approximately ten procedures before each surgeon felt comfortable performing the procedure.

On a visual analog scale ranging from 0 (no postoperative pain) to 10 (the most imaginable pain), our patients experienced an average pain score of 1.1 on postoperative day one. This decreased to 0.7 on day seven, and 0.2 on day 21. Subsequent to this, all scores have remained at zero.

Two patients experienced post operative bleeding. One patient resolved with bed rest, and the other patient required a return to the operating room with suture ligation of a small bleeding artery at the staple line.

One patient experienced a mild postoperative anal stenosis. This has subsequently resolved. The pathology report showed squamous epithelium in the resected specimen. It was this case which encouraged us to change our operating technique such that we now routinely remove the circular anal dilator and evert the anal mucosa to be sure that we can see the dentate line to be sure that it is not entrapped within the jaws of the instrument. Finally, three patients experienced a sense of fecal urgency. These all resolved within three weeks. There were no incidences of infection or sepsis.

All patients reported complete satisfaction with the results and postoperative course. There have been no recurrences of symptoms or of hemorrhoids.

DISCUSSION

Most prospective randomized studies have shown that stapled hemorrhoidectomy is associated with significantly less postoperative discomfort and disability when compared with traditional, open hemorrhoidectomy.(10-21) Correa-Roveco et al. obtained a pain score of 5.5 (traditional) vs. 2.8 (stapled) at 24 hours (p<0.001) and 3.7 vs. 1.1, respectively, at two weeks (p=0.001).(16) Consequently there was significantly less narcotic and anti-inflammatory use in the stapled group (p<0.001). Similarly, Kairaluoma et al. showed an average pain score over 14 days of 4.3 for the traditional group vs. 1.8 in the stapled group (p=0.0002).(21) In terms of maximal pain scores, Cheetham et al. showed a max pain score of 9.0 following traditional hemorrhoidectomy compared to only 4.5 for stapled hemorrhoidectomy (p=0.018).(20) As expected, less pain translates into a shorter recovery time and a quicker return to the activities of daily life and work. Hetzer et al. showed patients being disabled an average of 20.7 days following traditional hemorrhoidectomy compared to only 6.7 days following stapled hemorrhoidectomy (p=0.001).(18)

Our results further support these findings. Early postoperative pain scores were minimal and rapidly approached zero. Furthermore, most of our patients were able to return to their usual activities with in a few days. There were minimal complications associated with the procedure and patients have been very satisfied with their results.

There were no post-operative infections in our series. There are case reports of sepsis after both open(22-24) and stapled hemorrhoidectomy,(25-28) as well as after hemorrhoidal sclerotherapy(29-31) and hemorrhoidal banding.(5-7) This complication seems to be secondary to the hemorrhoidectomy itself, and not to the manner in which the hemorrhoidectomy is performed.

Intermediate results of a multicenter, American study were presented at the 2003 annual meeting of The American Society of Colon and Rectal Surgeons. Results showed that stapled hemorrhoidectomy is associated with less postoperative pain and fewer postoperative adverse events when compared head to head with a Ferguson hemorrhoidectomy. Additionally, stapled hemorrhoidectomy was also associated with significantly fewer recurrences of symptoms in the postoperative period.(32)

CONCLUSION

Stapled hemorrhoidectomy is a revolutionary advance in the treatment of a common but vexing problem. Worldwide, it continues to grow in popularity as the procedure of choice in the surgical treatment of hemorrhoids. In the United States, it is being used with increasing frequency.

To date, three hundred thousand stapled hemorrhoidectomies have been performed worldwide. Our evaluation, and multiple other studies have shown that stapled hemorrhoidectomy is safe and is associated with a minimum of postoperative discomfort. Multiple European prospective randomized studies have demonstrated the safety and efficacy of this procedure, and currently several prospective randomized studies are underway in the United States in order to further evaluate the short term and long term results of the procedure.

Stapled hemorrhoidectomy is safe to learn in the private practice setting. It must be learned under the guidance of a surgeon specifically trained in the surgical anatomy of the anorectum and in the use of the hemorrhoidal stapler. This is critical.

Close attention must be given to each step of the procedure. The learning curve appears to be approximately ten cases. Two trained surgeons (one of whom is a colorectal specialist) should be present at each procedure.

TO STAPLE OR NOT TO STAPLE?

Based on our experience and on the experience of others as referenced in the worldwide literature, we believe that in the hands of specifically trained and skilled surgeons, stapled hemorrhoidectomy should be considered to be the gold standard in the surgical treatment of hemorrhoidal disease.

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Acknowledgements

Acknowledgement is hereby given to Ethicon Endo-Surgery Inc. for permission to use anatomical and procedural illustrations. Copyright 2001, Ethicon Endo-Surgery, Inc., a Johnson and Johnson company. Reprinted with permission from Ethicon-Endo Surgery, Inc. All rights reserved.