Stapled Hemorrhoidectomy With Local Anesthesia can be Performed Safely and Cost-Efficiently
- First Online:
- Cite this article as:
- Esser, S., Khubchandani, I. & Rakhmanine, M. Dis Colon Rectum (2004) 47: 1164. doi:10.1007/s10350-004-0550-y
- 41 Views
This prospective study was designed to assess the feasibility of performing the procedure for prolapsing hemorrhoids, or stapled hemorrhoidectomy, under local anesthesia supplemented with conscious sedation.
Seventy consecutive patients (mean age, 56 years; 37 males) with Grade 3 or 4 hemorrhoids underwent the procedure for prolapsing hemorrhoids after perianal infiltration of 0.5 percent lidocaine with 1:200,000 epinephrine and supplemental conscious sedation. The procedure was performed in an outpatient setting, with the patient being discharged within two hours of checking into the ambulatory facility. All patients were assessed the following day by telephone, and then in the office at three weeks and two months for degree of postoperative pain, bleeding, continence, and time back to work or social activities. Additionally, all excised mucosal anastomotic rings were analyzed for presence or absence of muscle.
Each patient rated the pain as minimal or none. Five patients complained of mild, transient perineal pressure, and three complained of fecal urgency and seepage before their first office visit; one complained of external skin tags at the second office visit. All subjects were back to work or social activities within three to four days—most within 48 hours. Complications included urinary retention in five patients, two of whom had a concomitant urinary tract infection, and one had urosepsis requiring hospitalization. One patient required immediate reoperation for bleeding from the staple line. Another patient was admitted for postoperative bleeding and packed with a hemostatic agent the evening of surgery. Muscularis propria fibers were identified in 68 of 70 pathologic specimens.
Administration of general, spinal, or epidural anesthesia for the procedure for prolapsing hemorrhoids is well described. This study suggests that the use of local anesthesia supplemented with conscious sedation for the procedure for prolapsing hemorrhoids yields results equivalent to those achieved with general or regional anesthesia without the attendant risks and additional costs. This study also suggests that the presence of muscle fibers in the pathologic specimen does not seem to lead to increased pain or impaired continence, although it was not specifically designed to address this issue.
Key wordsProlapsing hemorrhoidsHemorrhoidectomyStapled hemorrhoidectomyOutpatient procedureLocal anesthesiaConscious sedationPainContinence
Hemorrhoidectomy has historically been considered a painful procedure. Goligher1 recalls a patient describing a bowel movement as “like passing pieces of broken glass.” For this reason, outpatient procedures such as rubber band ligation,2, 3, 4 injection sclerotherapy,5 infrared coagulation,5 and cryotherapy6 are still used frequently for Grade I and II hemorrhoids but have been shown to have high recurrence rates with Grade III and IV hemorrhoids.5
Until the early 1990s, the two main surgical treatments for Grade III and IV hemorrhoids were open (Milligan-Morgan)7 and closed (Ferguson)8 techniques, which have undergone modifications over the years9, 10 but still cause patients suffering.11, 12 Addition of such modalities as lateral internal sphincterotomy,13 trimbutine,14 metronidazole,15, 16 and topical nitroglycerin17 to these procedures have had mixed results on postoperative pain. Other techniques such as CO2 laser,18 Harmonic Scalpel®(Ethicon Endo-Surgery, Cincinnati, OH),19, 20, 21 and LigaSure™ (Valleylab, Boulder, CO)22 hemorrhoidectomy have been tested in small clinical trials and yielded similar variable results.
The Whitehead-Rand hemorrhoidectomy23, 24 is an alternative technique for circumferential Grade III and IV hemorrhoids that, in properly selected patients, yields good results.25, 26, 27, 28 The procedure for prolapsing hemorrhoids (PPH) was first adapted to a circular endorectal stapler by Allegra in 199029 and later by Pescatori et al.,30 and in a larger study by Longo,31 who proposed alleviating symptoms without affecting function by interrupting the blood flow to the hemorrhoids by circumferentially excising mucosa and submucosa rather than the hemorrhoids themselves. More than 50,000 stapled hemorrhoidectomies were performed in Europe and Asia before the publishing of the first three, major, randomized studies, which demonstrated decreased operative time and pain, earlier discharge and return to work and activities, and similar short-term efficacy compared with conventional hemorrhoidectomy.32, 33, 34 Other studies supporting these findings soon followed, some prospective or retrospective,35, 36, 37 some randomized,38, 39, 40, 41, 42, 43 and one meta-analysis.44 To date, there have been seven negative articles regarding PPH.44, 45, 46, 47, 48, 49, 50 One claims no advantage,45 two claim greater failure rates,46, 47 and one widely publicized article reports persistent pain and fecal urgency.48, 49 Three others are case reports of pelvic sepsis50 and rectal perforation.51, 52
The first experience with PPH in the United States was not reported in the literature until 2002, emphasizing that PPH is safe, effective, and can be performed as an outpatient procedure with local or regional anesthesia.53 All other studies, with the exception of two,36, 54 describe the use of general, spinal, or epidural anesthesia for PPH. We hypothesized that we could get similar results by performing PPH under local anesthesia with supplemental conscious sedation and that all patients would be suitable for discharge on the same day.
PATIENTS AND METHODS
Seventy patients (37 males; mean age, 56 years) with symptomatic Grade III (n = 24) or Grade IV (n = 46) prolapsing hemorrhoids were included in this prospective study. Patients with concomitant anorectal pathology were not offered PPH. Patients with large external hemorrhoids were counseled and excluded if they were particular about cosmetic result. Therefore, the series consisted of all eligible, consecutive patients with or without external hemorrhoids. Institutional review board approval was obtained; because the study was considered to be a variation of previously published studies, no special consent by the patient was deemed necessary.
Patients were instructed to self-administer a Fleet® enema (CB Fleet Co., Inc., Lynchburg, VA) on the morning of the operation. Preoperative antibiotics were not administered. All operations were performed under local anesthesia with supplemental intravenous sedation at the same outpatient surgical facility.
The Proximate® HCS Hemorrhoidal Circular Stapler (Ethicon Endo-Surgery, Inc., Cincinnati, OH) and included supplies were used for all operations. Patients were placed in the prone jackknife position, and after administration of midazolam and/or fentanyl, the perianal area was prepared and infiltrated with approximately 15 ml of 0.5 percent lidocaine with 1:200,000 epinephrine solution, first superficially into the perianal skin, and then deep into the submucosal plane in all four quadrants. The circular anal dilator and obturator were then inserted into the rectum. After securing the dilator to the skin with 0 silk sutures, the obturator was removed and the pursestring suture anoscope was inserted to facilitate placement of a 0 Prolene® (Ethicon, Somerville, NJ) pursestring suture through the mucosa and submucosa 4 to 5 cm proximal to the dentate line. Once completed, the pursestring suture was gently tightened to draw the redundant rectal mucosa into the lumen of the rectum. Next, the fully opened stapler was inserted through the pursestring into the rectum. A gentle “pop” could be felt as the anvil passed across the pursestring suture. The ends of the suture were then pulled through the lateral channels of the stapler housing with the aid of the hooked suture threader. An “air-knot” was tied, and this suture was used for traction as the stapler was closed and advanced into the rectum until the 4-cm mark on the head of the stapler was at the anal verge. One minute was allowed to elapse for hemostasis before firing the stapler.
During this time, in females a digital vaginal examination was performed to ensure that the stapler had not included the posterior vaginal wall. After firing the stapler, it was held closed for an additional minute to assist in hemostasis. The head of the stapler was then opened two full turns and removed. The pursestring anoscope was used to inspect all four quadrants for bleeding and anastomotic integrity. The majority of patients had bleeding or separation, and 3-0 Vicryl® (Ethicon) figure-of-eight sutures were used for repair. Hemostatic agents were used selectively along the staple line. The anastomotic ring was removed from the stapler, flattened out on the backtable, visually inspected for muscle fibers, and sent to pathology for analysis.
Patients were sent to the recovery room and all were subsequently discharged home within two hours. At the time of discharge, oral narcotics were prescribed, and patients were instructed to take sitz baths. Two bisacodyl tablets were provided to be taken the evening of surgery to facilitate early bowel movement. One surgeon (MR) routinely prescribed postoperative metronidazole. At follow-up office call the day after surgery and all subsequent postoperative office visits, patients were examined and questioned about hemorrhoid symptoms and bowel habits.
Seventy patients underwent stapled hemorrhoidectomy during the period from January 2002 to December 2002. Operations were performed by one of two board-certified colorectal surgeons (IK and MR). Every operation attempted was successfully completed. No major complications occurred. The majority of the patients required figure-of-eight sutures to control bleeding at the staple line.
One patient returned to the operating room the same day for bleeding from the staple line and was discharged two hours after packing. No oversewing of the staple line was necessary. Another patient was admitted through the emergency department for postoperative rectal bleeding the evening of surgery, which required a hemostatic pack in the rectum. Five patients had postoperative urinary retention requiring catheterization. Of these, two patients had concomitant urinary tract infections, and one patient had urosepsis and rectal pain, which required hospitalization. The perineal pressure sensation produced false urges and, in fact, is not a true retention. The incidence of retention is higher with regional and general anesthesia.
Evaluation of pain was performed by providing the patient with a color-coded chart for self-assessment and delineation of the degree of pain. All patients received a telephone call from the nursing staff the following morning and were questioned regarding the degree of pain and the use of analgesics. The patients were discharged home with a prescription for oxycodone (5-mg tablets). Further evaluation of pain was recorded by one of the two operating surgeons, preferably blinded, at the first follow-up in the office three weeks after the operation. Almost all patients experienced minimal or no pain at digital inspection and reported little bleeding after defecation. Five patients (7 percent) complained of a mild rectal pressure sensation, one patient (1 percent) had to digitally disimpact her rectum, and three patients (4 percent) complained of some anal seepage and urgency. All of these complaints had disappeared by the two-month visit.
Endoscopic examination showed induration and granulation at the staple line, which took as long as eight weeks to resolve, until most of the staples were expelled. All patients were back to work or social activities within three to four days. Histologic examination of the anastomotic tissue rings was made in all patients, and the presence of muscle fibers was detected in 68 of 70 patients (97 percent).
All patients noted satisfaction with the procedure with an improved quality of life and symptomatology. Quality of life was assessed by the degree of discomfort and return to social activities and employment. No patient had incontinence to flatus, liquids, or solids at the two-month visit. The status of continence was evaluated by direct questioning by the surgeons. No manometry was performed.
The lack of external surgical wounds, the short operative time, and negligible postoperative pain make PPH under local anesthesia with supplemental conscious sedation an attractive option for the treatment of Grade III or IV hemorrhoidal disease. Our study is not the first to describe this type of anesthetic technique for PPH, although ours differs in a few ways.
Arnaud et al.36 described PPH under local or regional anesthesia, although the type and amount of local anesthetic was not mentioned. Additionally, they routinely gave preoperative antibiotics and placed a Foley catheter, which is not our practice. Their mean length of stay was 36 hours, whereas all of our patients went home within 2 hours after operation with only one readmission.
Gabrielli et al.55 described the use of “modified regional anesthesia,” consisting of a technical modification of Marti’s posterior block.56 This involves a deep and superficial infiltration, which seems more cumbersome than our technique. Additionally, their local anesthetic of choice was ropivacaine, which takes five minutes to work, as opposed to the instantaneous action of lidocaine. They also had to keep eight patients overnight, although they only had three patients with urinary retention, which was lower than that reported in traditional anorectal surgery with general or spinal anesthesia.57
Singer et al.53 also described PPH under local anesthesia. Their study was conducted at two institutions, Washington University in St. Louis and University of Illinois at Chicago. All 27 patients at Washington University underwent PPH under local with 0.25 percent bupivacaine with 1:100,000 epinephrine, whereas all 41 patients at University of Illinois underwent PPH under spinal or general anesthesia. However, 96.3 percent of patients at Washington University were admitted for a 23-hour stay (for purposes of the study only), whereas only 9.8 percent of patients at University of Illinois stayed overnight. Interestingly, an article recently published from Washington University touted the benefits of performing anorectal surgery under local anesthesia, with an emphasis on quicker discharge and potential cost savings,58 so it is not entirely clear why the overwhelming majority of their PPH patients stayed overnight in the hospital.
Most studies mentioned the presence of muscle fibers in the excised mucosal rings.32, 34, 36, 38, 39, 40, 41, 42, 43, 46, 47, 48, 53 One asserted that resected specimens should not contain any muscular fibers because this can predispose to stricture,36 and another claimed that muscle fibers may lead to persistent pain and fecal urgency.48 All other studies reported muscle fibers in the pathologic specimen but observed that this had no effect on postoperative pain or anal continence. Two articles make the point that the muscle fibers may actually be part of the muscular layer of the rectal wall rather than the internal anal sphincter.38, 40 Our data support the conclusion that inclusion of small amounts of muscle fibers by the stapler has no deleterious effect on postoperative anal continence or comfort.
Bleeding after hemorrhoidectomy is the most common reason for reoperation. We only had one patient return to the operating room to control bleeding. This was encouraging, considering that almost all patients required a hemostatic suture on the staple line intraoperatively. Singer et al.53 had similar findings in 90 percent of their patients, leading them to conclude that bleeding should be considered a routine part of the operation rather than a complication.
Even among supporters of PPH, increased costs seem to be an issue. The stapler itself costs approximately $450.00. Ho et al.34 found that the cost over a three-month period for conventional hemorrhoidectomy was $921.17 vs. $1,283.09 for PPH (P < 0.005). There was no difference in anesthesia charge between the two procedures, and we performed both procedures in the same time all under local with sedation. PPH costs more for the patient and insurance company, at least initially. However, the first three randomized studies showed a quicker return to work,32, 33, 34 and this was corroborated by most other subsequent trials.35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 53, 54 This, along with a decreased hospital stay, should lead to less costs overall for PPH for society in the long run. Wilson et al.43 observed a total procedure cost of $1,798.00 for open hemorrhoidectomy, $1,156.00 for Autosuture™ stapled anopexy, and $1,312.00 for Ethicon™ stapled anopexy, based on operating room charge of $1.40 per minute and hospital charge of $34.00 per hour for an inpatient stay. Our technique also should decrease charges, because local anesthesia with sedation costs less than general anesthesia and should decrease postoperative morbidity and the chances of an overnight stay.
A word of caution: adoption of PPH in the United States was considerably delayed because of reports of high complication rates from Europe. The instrument was handed to the practitioner (not always surgeons) in an indiscriminate manner. In the United States, the manufacturer has shown responsibility by making the instrument available to surgeons (preferably colon and rectal surgeons) who have completed a prescribed training program and obtained a certificate for presentation to the institutional credentialing committee.
Stapled hemorrhoidectomy has proven to be a viable alternative, perhaps even superior to conventional hemorrhoidectomy in the treatment of Grade III and IV hemorrhoids. The benefits of PPH can be more fully realized by the simple application of local anesthesia with supplemental intravenous sedation to the procedure. Long-term follow-up is not available and remains to be seen.