Radiofrequency
Radiofrequency energy delivery (Secca® procedure;
Curon Medical) is a newer modality for treating fecal incontinence originally used for treating gastroe- sophageal reflux disease [1], benign prostatic hyper- plasia [2], and joint-capsule laxity [3]. After being found a safe and effective means of strengthening tis- sues, its beneficial effects were first used within the anal canal in Mexico in 1999. Since then, demon- strated improvements have prompted further inves- tigation, with promising results, for use within the anal canal. The radiofrequency generator produces heat by a high-frequency, alternating current that flows from two electrodes–active and dispersive–
causing frictional movement of ions and tissue heat- ing [4]. This procedure is not an option for obvious sphincter defects but can be used with a weak or thinned anal sphincter complex. Patients with a his- tory of inflammatory bowel disease (IBD), extensive perianal disease, or chronic diarrhea should not be offered this treatment.
The exact mechanism of action is unknown, although the current hypothesis is that the tempera- ture-controlled energy heats the tissue causing colla- gen contraction and initiates focal wound healing in the sphincter muscle, actually tightening the tissue [5]. Preliminary animal studies demonstrated small areas of fibrosis within the anal sphincter [6]. In a prospective follow-up study of ten women, Takahashi et al. [7] showed that symptomatic improvement per- sists for 2 years after delivery of radiofrequency ener- gy to the anal canal. The patients answered question- naires including the Cleveland Clinic Florida Fecal Incontinence (CCF-FI) scale, Fecal Incontinence Quality of Life (FIQOL) score, and the Short Form–36 (SF-36) at baseline and at 1, 2, 3, 6, 12, and 24 months after the procedure. At 24 months, the CCF-FI score improved from 13.8 to 7.3. The FIQOL score also improved significantly. There was no decrease in effect shown from 12 to 24 months postprocedure. Of note, manometric studies show a significant reduc- tion in initial and maximal rectal volumes, although
resting and squeeze pressures have not been demon- strated to change after treatment [7].
Patients who may be candidates for this treatment should have no definite sphincter defect, as overlap- ping sphincteroplasty is still the optimal treatment.
Radiofrequency can still be used as an adjunct post sphincter repair. Patients who have IBD, chronic diarrhea, anal fissure, or abscesses should not under- go this treatment.
The procedure itself is simple to perform, requires minimal sedation, and can be performed in an ambu- latory setting requiring no hospital admission. The patient is placed in the prone jackknife position with the buttocks taped apart. The handheld disposable anoscope (Fig. 1) is inserted into the anal canal 1 cm distal to the anal verge. The needle electrodes are deployed, and the radiofrequency energy is delivered deep within the muscle, while the mucosa and sub- mucosa are cooled by constant external irrigation.
The needle electrodes contain sensors to prevent overheating and tissue desiccation. The energy is
Radiofrequency
Jenny Speranza, Steven D. Wexner
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Fig. 1.Handheld disposable anoscope is inserted into the anal canal 1 cm distal to the anal verge
deployed for 90 s to achieve a temperature of 85 °C.
If the resistance or the mucosal tissue becomes too high, the energy being delivered to the tissue will be automatically discontinued. The main control unit (Fig. 2) displays the time elapsed, tissue and mucosal surface temperature, and the resistance of each elec- trode (Fig. 3). This procedure is carried out in 0.5-cm increments proximally along the distance of the internal sphincter and then repeated in each quad- rant of the anal canal. By the end of the procedure, approximately 16–20 thermal lesions are created along the internal anal sphincter (Fig. 4).
Radiofrequency energy has proven to be an effec- tive modality in treating fecal incontinence. In a mul- ticenter study, Efron et al. [8] demonstrated a signif- icant improvement in both CCF-FI and FIQOL scores. Fifty patients at five centers were enrolled.
Initially and 6 months postprocedure, patients com- pleted the CCF-FI score, the FIQOL score, the SF-36, and visual analog scale (VAS). At 6 months, the CCF- FI score improved from 14.5 to 11.1 (p<0.0001).
FIQOL scores all improved significantly, although anal manometry and anal ultrasound showed no changes. Complications were minimal and included mucosal ulceration and delayed bleeding in one patient.
Radiofrequency energy delivery is minimally invasive requiring only sedation and can be per- formed on an outpatient basis. It is ideal as a pre- liminary step in a patient with multiple comorbidi- ties who may not be able to tolerate a lengthier pro- cedure. Radiofrequency energy delivery has been shown to be a relatively safe treatment with minimal morbidity, including mucosal ulceration and bleed- ing [8]. It is a simple procedure that can be used alone or in conjunction with other modalities in the challenging, often difficult realm of treating fecal incontinence. The Secca procedure is approved by the US Federal Drug Administration for use in the United States. However, the Curon Company filed bankruptcy on November 15, 2006, and therefore this technology is not available at the time of publi- cation of this chapter.
References
1. Triadafilopoulos G, DiBaise JK, Nostrant TT et al (2002) The Stretta procedure for the treatment of 230 J. Speranza, S.D. Wexner
Fig. 2.The main control unit displays the time elapsed and tissue and mucosal surface temperature
Fig. 3.The main control unit also displays the resistance of each electrode
Fig. 4.By the end of the procedure, 16–20 thermal lesions have been created along the internal anal sphincter
Chapter 23 Radiofrequency
GERD: 6 and 12 month follow-up of the U.S. open label trial. Gastrointest Endosc 55:149–156
2. Issa MM, Oesterling JE (1996) Transurethral needle ablation (TUNA): an overview of radiofrequency ther- mal therapy for the treatment of benign prostatic hyperplasia. Curr Opin Urol 6:20–27
3. Hecht P, Hayashi K, Cooley AJ et al (1998) The thermal effect of monopolar radiofrequency energy on the por- perties of joint capsule. An in vivo histologic study using a sheep model. Am J Sports Med 26:808–814 4. Person B, Wexner S (2005) Advances in the surgical
treatment of fecal incontinence. Surg Innovation 12:7–21 5. Gustavson KH (1964) On the chemistry of collagen.
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6. Takahashi T, Garcia-Osogobio S, Valdovinos M et al (2002) Radio-frequency energy delivery to the anal canal for the treatment of fecal incontinence. Dis Colon Rectum 45:915–922
7. Takahashi T, Garcia-Osogobio S, Valdovinos M et al (2003) Extended two-year results of radio-frequency energy delivery for the treatment of fecal inconti- nence(the Secca Procedure). Dis Colon Rectum 46:711–715
8. Efron, JE, Corman ML, Fleshman J et al (2003) Safety and effectiveness of temperature-controlled radio-fre- quency energy delivery to the anal canal (Secca® pro- cedure) for the treatment of fecal incontinence. Dis Colon Rectum 46:1606–1616
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