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| 번호 | 제목 | 등록일 | 조회수 |
|---|---|---|---|
| 76 | Stapled Rectal Mucosectomy vs. Closed Hemorrhoidectomy [2002년 10월 DCR] | 2011-11-17 | 3281 |
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A Randomized, Clinical Trial
Jose´ Manuel Correa-Rovelo, M.D.,* Oscar Tellez, M.D.,* Leoncio Obrego´n, M.D.,*Adriana Miranda-Gomez, M.D.,* Segundo Moran, M.D.†
From the *Colon and Rectum Clinic and the †Gastroenterology Clinic, Me´dica Sur Hospital, Mexico City, Mexico
INTRODUCTION: We compared the safety and clinical outcome between stapled rectal mucosectomy and closed hemorrhoidectomy for the surgical treatment of noncomplicated hemorrhoidal disease.
METHODS: Eighty-four patients with Grade III and IV hemorrhoidal disease were randomly assigned to two groups: 1) stapled rectal mucosectomy group (n = 42) and 2) closed hemorrhoidectomy group (n = 42). Postoperative pain, analgesic use, symptoms, disability, early and late complications, and patient
satisfaction were evaluated, among others. Follow-up was six months. RESULTS: Eighty-four patients, averaging 45 +/- 9 years of age, underwent surgery. Two were lost to followup. Length of surgery and disability, postoperative pain, and use of analgesics were significantly less for patients in the stapled rectal mucosectomy group. In the closed hemorrhoidectomy group early complications were more frequent but not statistically significant, and there were no statistically significant differences regarding the frequency of late complications. No serious complications were reported in either group. Closed hemorrhoidectomy proved to be superior for bleeding control (95.1 percent closed hemorrhoidectomy vs. 80.5 percent stapled rectal mucosectomy; P = 0.04). Patient satisfaction was similar in the two groups, but stapled rectal mucosectomy patients were more
willing to undergo the same procedure (P = 0.02). CONCLUSION: Both stapled rectal mucosectomy and closed hemorrhoidectomy are safe procedures. Closed hemorrhoidectomy was superior for bleeding control in Grade III and IV hemorrhoidal disease, but more painful and disabling than stapled rectal mucosectomy.
Hemorrhoidal disease (HD) is very common among patients older than the age of 50. Treatment has varied and been controversial over the years and includes alternatives such as infrared ray
photocoagulation, electrocoagulation, sclerotherapy and closed or open hemorrhoidectomy. Although each has its specific indications, closed or open hemorrhoidectomy is currently considered the most effective treatment and has few complications. Nonetheless, the associated postoperative pain and disability make it an unpopular choice with patients. Anopexy, or stapled rectal mucosectomy (SRM), is an innovative procedure based on the principle of
healing symptoms without affecting functions. Pescatori, in 1997, reported the resection of mucous prolapse by means of a circular stapler. The principles of SRM and his experience with 144 patients over a 3-year period were reported by Longo in 1998. With this technique, hemorrhoidal packs are relocated within the anal canal by means of a circumferential resection of the mucosa located over these packs, between the rectal ampulla and the anal canal. Theoretically, the blood flow from the different submucous ramifications of the hemorrhoidal arteries is reduced. Because the procedure is done from above the dentate line, part or all of the transitional epithelium is preserved. Therefore, postoperative pain is less than the pain caused by a hemorrhoidectomy, and the sensitivity of the anal canal is preserved. Advantages of this technique include minimal pain, early return to activities, and scarce morbidity, according to comparative clinical trials. The safety of this method has recently been questioned after reports of persistent postoperative pain and fecal urgency following the procedure in patients followed up for a period of more than six months. Therefore, despite SRM being a promising technique, mediumterm and long-term comparative clinical trials between this procedure and traditional hemorrhoidectomy is required to determine its true therapeutic value. We designed a prospective, randomized study to evaluate the safety and clinical response of stapled rectal mucosectomy compared with closed hemorrhoidectomy (CH) in patients with uncomplicated Grade III and Grade IV hemorrhoidal disease. DISCUSSION
This study shows that both stapled rectal mucosectomy and closed hemorrhoidectomy are safe as a surgical treatment for patients with uncomplicated Grade III and IV hemorrhoidal disease. CH was superior for bleeding control in Grade III and IV hemorrhoidal disease, but more painful and disabling than SRM. In accordance with previous observations, our results with a large group of patients with at least a six-month follow-up indicate that SRM is performed faster, causes less postoperative pain, requires less intake of analgesics, allows bowel movement to be resumed sooner, and reduces the length of disability.
SRM has gradually been gaining acceptance among surgical groups in Europe, and recently in Asia and
America. Its postoperative period is considered less painful and less disabling than conventional open or closed hemorrhoidectomy, both of which have been shown to be equally painful. The information about the efficiency and safety of this new technique is based on reports of case series and comparisons with conventional techniques in the short-term. Two published studies include a series of 40 patients and another has been reported with 119 patients but a follow-up of three months. The decrease in postoperative pain in SRM is apparently a result of less trauma to the innervation of the anal canal, because free nerve endings located in the transitional area are closer to the anal valves. Because of the variable length of the transitional zone, a portion may have to be resected to reposition the hemorrhoids adequately by SRM, as happened in one-half of our patients. This does not mean that a subtotal hemorrhoidectomy must be performed. The inclusion of squamous epithelium must be avoided so that postoperative pain from SRM is less than that of a conventional hemorrhoidectomy.
As the pain experienced by patients may be influenced by the level of stapling—at least in some cases - the clinical response in the long run can be correlated with the level of stapling. In our study the level of stapling on average was 28.9 mm. Some clinical trials do not mention the level of stapling or the type of epithelium found. Longo believes that in some of these patients with pain, a subtotal hemorrhoidectomy with the stapler is performed instead of a hemorrhoid-preserving mucosectomy. This is important, because if the pursestring suture is placed 2 to 3 cm over the dentate line, perhaps part of the hemorrhoid is being included. In addition, it may be seen as anoderm in the histologic examination, as happened in three of the patients we operated on before this clinical trial. The percentage of early complications for the CH group was not significantly greater than that of the SRM group and all early complications were considered minor. Late complications in the two groups were similar. Contrary to that reported by Cheetham, none of our patients developed chronic and disabling anal pain caused by the SRM procedure. We cannot currently find a clear explanation for this discrepancy. Only 6 of 42 of our SRM patients took analgesics for more than 7 days for anal pain, and the longest time analgesics were used was 15 days. A female patient developed dyspareunia that lasted four weeks and remitted spontaneously. This could be attributed to the inclusion of rectovaginal septum,
because no other clear source was found. Other authors have reported that up to 8 percent of female patients experienced dyspareunia after coloanal or ileoanal anastomoses performed with a circular stapler. Our SRM patients did not present prolonged fecal urgency, contrary to that reported in another study. Some patients in both groups developed minor and temporary changes in continence during the first postoperative days, which we believe were part of an adaptation period perhaps because of transitory damage of anal sensitivity. Only one SRM patient and three CH patients experienced minor anal incontinence two months after the procedure. Anal incontinence persisted at further follow-up in two of the CH patients. One of these patients had previous damage to the external anal sphincter. SRM patients experienced no change in continence, despite similar findings of smooth muscle fibers in specimens from the two groups. Damages to the internal sphincter as diagnosed by endoanal ultrasound are rare and not necessarily associated with incontinence. Unlike other reports, none of our patients experienced fever 48 hours after the procedure, and no pelvic sepsis was found in either group.
Our findings regarding clinical response at two months are similar to those reported by Ho at six weeks.
At Month 3 Ho reports a 1.8-percent incidence of minor bleeding from the wound, but there are no
longer-term results. Although no significant difference in percentage of healing was found between the two techniques, bleeding control was higher for CH. According to a long-term report on closed hemorrhoidectomy by the Ferguson Clinic, 7.4 percent of 1,016 patients that were followed up during 5 years experienced some bleeding, and only 0.15 percent required surgical treatment because of additional hemorrhoidal tissue. Mc-Connel reported that 2.5 percent of 441 patients followed up 1 to 7 years experienced some bleeding, and 7.5 percent required some treatment because of a residual hemorrhoidal problem. According to a report by Longo, 23.8 percent of 101 patients with bleeding treated by SRM and followed up during at least one year experienced bleeding, of which 2.9 percent showed no improvement and 0.6 percent a partial recurrence. Thus a difference in the control of bleeding may be expected in the long term. The permanence of hemorrhoids even in cases of regression may predispose patients, whose prolapse has been corrected, to experience minor bleeding originating in capillaries of the lamina propria. Despite the clinical response, there was no difference in patient satisfaction between the groups. Nevertheless, a significantly higher number of SRM patients were willing to undergo the same procedure. We believe this is secondary to a more prolonged and disabling postoperative period caused by CH. The main cause of poor satisfaction within the SRM group was not bleeding, but rather the lack of regression of the external component. Thus, patients with a significant external component may benefit more from another technique.
Although a cost analysis was not considered in this research, we believe the use of the stapler in the SRM procedure increases the cost of the surgery. This is probably balanced by the cost associated with the disability caused by CH, although we did not analyze this.
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