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| 번호 | 제목 | 등록일 | 조회수 |
|---|---|---|---|
| 105 | Extended Two-Year Results of Radio-Frequency Energy Delivery for the Treatment of Fecal Incontinence (the Secca Procedure) [2003년 6월 DCR] | 2011-11-17 | 3590 |
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Takeshi Takahashi, M.D.,* Sandra Garcia-Osogobio, M.D.,* Miguel A. Valdovinos, M.D.,†Carlos Belmonte, M.D.,‡ Camilo Barreto, M.D.,* Liliana Velasco, M.D.*
From the Service of Colon and Rectal Surgery, *Department of Surgery and †Department of Gastroenterology,Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran and ‡Service of Colon and Rectal Surgery, Department of Surgery, Hospital Central Militar, Mexico City, Mexico
PURPOSE: This study evaluated the durability and long-term safety of radio-frequency energy delivery for fecal incontinence (Secca procedure).
METHODS: This was an extended follow-up of a prospective study in which patients with fecal incontinence of various causes underwent radio-frequency energy delivery to the anal canal muscle. The Cleveland Clinic Florida Fecal Incontinence Scale (0–20), fecal incontinence–related quality-of-life score, and Medical Outcomes Study Short Form 36 were administered at baseline and at 1, 2, 3, 6, 12, and 24 months after the procedure. Differences between baseline and follow-up were analyzed with the Wilcoxon signed-rank test.
RESULTS: Ten females (aged 55.9 +/- 9.2 (range, 44–74) years) were treated. At two-year follow-up, the mean Cleveland Clinic Florida Fecal Incontinence Scale score was improved from 13.8 to 7.3 (P
= 0.002), with eight patients having scores of <10. All fecal incontinence–related quality-of-life score parameters were improved, including lifestyle (from 2.3 to 3.3; P = 0.002), coping (from 1.7 to 2.7; P = 0.002), depression (from 2.4 to 3.4; P = 0.004), and embarrassment (from 1.5 to 2.4; P =0.008). There was no decrement in effect noted in any parameter between 12 and 24 months (P > 0.2). The social function component of the Short Form 36 improved from 50 to 82.5 (P = 0.04), whereas there was an improvement trend for the mental component summary of the Short Form 36 from 38.3 to 48.1 (P = 0.11). Protective pad use was eliminated in four of the seven baseline users. There were no long-term complications, such as stricture, pain, or constipation. CONCLUSIONS: A significant improvement in symptoms of fecal incontinence and quality of life persists two years after radio-frequency delivery to the anal canal, which demonstrates durability of this intervention. Fecal incontinence is defined as recurrent, uncontrolled passage of solid or liquid stool or gas for at least one month in an individual with a developmental age of at least four years. Although not specifically life-threatening, fecal incontinence has a severely negative impact on a patient’s lifestyle and overall quality of life. Fecal incontinence may affect certain demographic groups more commonly but is frequently associated with complications of obstetric or anorectal procedures. Patients may be reluctant to seek therapy because of either embarrassment or lack of knowledge regarding available therapeutic options.
Treatment for fecal incontinence is often stepwise, depending on disease severity and pathophysiology,
commonly beginning with dietary measures, pelvic exercises, antimotility agents, and biofeedback. Overlapping sphincter repair is an option for those patients who have a repairable defect and are candidates for general/spinal anesthesia, whereas artificial bowel sphincter implantation may be used in highly selected patients for whom colostomy is the only option. The administration of temperature-controlled radio-frequency (RF) energy delivery to the anal canal
muscle (Secca procedure) was used for the first time for treating fecal incontinence at Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran in Mexico in 1999. One-year follow-up demonstrated improvement in fecal incontinence symptoms, fecal incontinence–related quality of life, and general quality of life (Medical Outcomes Study Short Form 36 (SF-36)). The proposed mechanism of action is heatinduced tissue contraction and remodeling of the anal canal and distal rectum. A significant reduction in initial and maximum rectal volumes was noted on anorectal manometry. Whether the positive clinical benefits of the Secca procedure noted at one year are durable is an important issue in determining the role of this procedure in the longer-term management of fecal incontinence. The purpose of this article is to extend the follow-up period of this clinical trial and evaluate the two-year results of the Secca procedure on fecal incontinence symptoms and to survey for long-term complications.
  DISCUSSION Therapies for fecal incontinence are often evaluated on the basis of relatively short-term results (1 year or less), despite fecal incontinence being a chronic, often lifelong disorder. Long-term durability and safety of any intervention must be considered when a management strategy is selected for these
patients.
Biofeedback entails very little risk to the patient and is therefore offered early in the treatment algorithm
for fecal incontinence. A significant failure rate of biofeedback therapy may present over time, often necessitating additional training sessions after one year to maintain the results. Overlapping sphincter repair is used for selected patients who present with a repairable sphincter defect
and who are able to tolerate general/spinal anesthesia. Success rates range from 69 to 93 percent, although efficacy may decrease slightly over time. Artificial bowel sphincter implantation is offered selectively to end-stage patients who are considering colostomy, yet durability is hampered by the high incidence of infection and extrusion associated with this procedure. RF energy delivery to the anal canal muscle is a safe, well-tolerated outpatient procedure that can be
performed without need for general anesthesia. There were no long-term adverse sequelae of this procedure. Additional study is under way to further elucidate the mechanism of action of this procedure and to evaluate the procedure in a randomized, sham-controlled, double-blind clinical trial. The present data support the effectiveness and durability of the procedure for improving CCF-FI, all
parameters of the FIQL, the social function component of SF-36, and protective pad use. These findings corroborate those of Efron et al.in 50 patients treated in a United States trial with the Secca procedure. There was no decrement in effect between one and two years in this study. This procedure may be appropriate, therefore, for those patients with chronic fecal incontinence who have failed conservative measures and are neither candidates for overlapping sphincter repair nor willing to undergo artificial bowel sphincter implantation or colostomy. An additional potential patient population to be considered, although not treated in the present study, comprises those patients with recurrent fecal incontinence symptoms after previous overlapping sphincter repair. |
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