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Endoscopic options for fecal incontinence
Endoscopic Options for Fecal Incontinence Elisa H. Birnbaum, MD
Radiofrequency energy has been used for treatment of gastroesophageal reflux disease, benign prostatic hypertrophy, and joint laxity. The use of the SECCA procedure (submucosal delivery of radiofrequency energy to treat fecal incontinence) has been recently reported for fecal incontinence. Improvement in reported symptoms of fecal incontinence and quality has been reported. There has been no improvement in anal manometric findings in follow-up evaluations. No significant new defects have been noted on endo-anal ultrasound. The precise mechanism of action of radiofrequency energy in the treatment of fecal incontinence is unknown. Ongoing trials will help define the role for this technology. © 2004 Elsevier Inc. All rights reserved.
reatment of fecal incontinence is dependent on the severity and pathophysiology of the incontinence and should be approached in a step wise fashion First line therapy for mild incontinence is generally dietary alterations, antimotility medications, and pelvic floor exercises. More severe symptoms of fecal incontinence warrant a work-up to evaluate for neurogenic or mechanical injuries. Anal manometry, electromyography, and endo-rectal ultrasound are used to determine whether there is a defect in the internal or external anal sphincter and if the pudendal nerve terminal motor latency is abnormal. Patients with mechanical sphincter injuries are candidates for surgical repair. Anal sphincter reconstruction is performed if there is a defined injury to the external anal sphincter. Biofeedback has been used for second-line treatment for patients with fecal incontinence not amenable to surgical repair or in whom surgical repair has not been successful. Unfortunately, there are a large number of patients who have symptoms of fecal incontinence who have failed the first and second-line treatment options. There are limited additional options for patients with fecal incontinence in whom conservative therapy has failed. Radio frequency energy has been used to treat a variety of benign and malignant diseases in an effort to cause mechanical shrinkage and fibrosis.1-4 The radio-frequency energy heats tissue by means of water molecule friction. At temperatures greater than 65° C, collagen contraction and thus tissue shrinkage occurs. The remodeling of collagen reduces the wound volume over time. This has been shown to occur when radiofrequency energy is used in the treatment of benign prostatic hypertrophy1 and in lax joint capsules.2 Radio-frequency en-
T
From the Section Of Colon and Rectal Surgery, Washington University School of Medicine, St Louis, MO. Address reprint requests to Elisa H. Birnbaum, MD, Associate Professor of Surgery, Section Of Colon and Rectal Surgery, Washington University School Of Medicine, 660 South Euclid Ave, Box 8109, St. Louis, MO 63110. © 2004 Elsevier Inc. All rights reserved. 1096-2883/04/0601-0009$30.00/0 doi:10.1053/j.tgie.2004.02.001
38
ergy has been used in the treatment of gastroesophageal reflux disease (GERD) and has been shown to thicken the lower esophageal sphincter submucosa and circular layers.3 Quality of life scores are significantly improved and there is a decrease in the esophageal acid exposure time after treatment of patients with GERD. Although patients improved symptomatically, there were no significant changes in the mean lower esophageal sphincter pressures.4 Radio-frequency energy (SECCA procdure) was first used for fecal incontinence in 1999.5 This initial trial was a feasible study involving 10 patients and showed that radio-frequency energy could be delivered safely to the anal sphincter. Improvement in the Cleveland Clinic Florida scale for Fecal Incontinence and patient reported quality of life prompted further evaluation of this technique.
Technique The SECCA procedure can be done in the Ambulatory Center or Endoscopy Unit with intravenous sedation and local anesthesia. Patients are instructed to discontinue platelet-inhibiting medications 7 days prior to treatment to minimize bleeding from the treatment sites. A bowel-cleansing enema is given prior to the procedure and prophylactic antibiotics are given. The patient is placed in a prone jack-knife position and local anesthesia is given. The thickness of the rectal-vaginal septum is evaluated in female patients to determine the proximal extent of needle/lesion placement in the anterior quadrants. The radio frequency energy device (SECCA; Curron Medical, Sunnyvale, CA) is a clear plastic anoscopic barrel with a light cable for visualization (Fig 1). The device is positioned under direct visualizations so that the needles are aligned at the dentate line. The needle electrodes are deployed from within the anoscopic barrel (22 gauge, 7-mm length). Once deployed there is a reduction in the electrical impedance indicating electrode muscle contact. If a reduction in the impedance is not seen, the needles are redeployed to get improved contact with the sphincter. Thermo-couples (electrical thermometers) present within the tip and at the base of each needle monitor tissue and mucosal temperatures during the delivery of the radio-frequency energy and provide temperature feedback. A target temperature is preselected (85°centigrade) and the power is modulated to achieve this temperature. Continuous cooling of the mucosa is done via continuous outflow of cold water to the base of each needle to minimize surface mucosal ulceration. The generator delivers energy for 90 seconds. Once the energy is delivered, the needles are retracted and the instrument is advanced 0.5 cm proximal to the treatment site and the process is repeated. A total of four rings of treatment are produced between the dentate line and 15 mm proximal to the dentate line. In women with short sphincter length and thin rectal vaginal septum fewer lesions are placed in the anterior quadrants to minimize complications. The therapeutic
Techniques in Gastrointestinal Endoscopy, Vol 6, No 1 (January), 2004: pp 38-40
Fig 1. Radio-frequency energy delivery device (SECCA; Curron Medical, Sunnyvale, California) the clear barrel has a light for visualization. The circular black marking (arrow) shows the level from which needle electrodes are deployed. (Reprinted with permission.7)
goal is to create thermal lesions in the muscle while preserving mucosal integrity (Fig 2). The number of patients treated with this modality is limited; therefore. follow-up examination and evaluation as reported in the literature is limited.5-7 Reported complications have been minimal. Most of the complications are acute discomfort after the procedure and occasional minor bleeding. Superficial ulceration can occur if mucosal cooling is not optimized. Anal strictures have not been reported. One patient has developed an abscess in the rectovaginal septum that resulted in a significant rectovaginal fistula following a SECCA treatment (D. Beck, personal communication, December 2003). There appears to be no anatomic or physiologic change in the anal sphincter after treatment with radio-frequency energy. Anal manometry performed pre-treatment and six months post treatment did not show measurable differences in rest or squeeze pressures in patients who reported improved continence.6,7 Pudendal nerve terminal motor latency is not altered and there have been no additional findings of new defects or scar tissue when endo-anal ultrasound has been performed.6,7 Patient reported fecal incontinence symptoms and quality of life has been shown to be improved.5-7 In the initial study, by Takahashi et al, the median Cleveland Clinic Florida Fecal ENDOSCOPIC OPTIONS
Incontinence (CC-FI) score improved from 13.5 to 5 (P ⬍ .001) with 80% of patients considered responders at 12 months.5 A 2-year follow-up of the same patients showed that this improvement persisted.6Twenty-four months after the SECCA procedure the mean CC-FI score improved from 13.5 to 7.3 (P ⫽ .002) and eight patients had scores of less than or equal to 10. Similar improvements in patient reported fecal incontinence and quality of life were seen in a multicenter trial by Efron et al.7 The questionnaires were given at baseline and 6 months post-treatment. These authors found that although patient symptoms improved, the CC-FI scores did not show as dramatic an improvement (14.5 to 11.1 P ⬍ .0001) as reported in the earlier trials.5,6 The precise mechanism of action for the SECCA procedure has not been determined. The initial hypothesis was that the radio-frequency energy would result in a circumfential thermal lesion which would contract and “tighten” the internal anal sphincter. The hypothesis that this technique would improve resting and/or squeeze pressures has not been supported by initial data.6,7 Although symptomatic improvement has been documented, the exact population studied in these limited trials is a heterogeneous population with regards to fecal incontinence and mechanical anal sphincter defects.
39
Fig 2. Thermal lesions are delivered in four rings of treatments, beginning at the dentate line and moving approximately 5mm intervals. A total of 64 lesions are delivered in this way. (Reprinted with permission.6)
Many questions are still unanswered, including the mechanism of action and patient selection. Although on the surface it appears as if radio frequency energy may be a useful modality for treatment of fecal incontinence, further studies are warranted. A multicenter randomized controlled trial is currently underway.
References 1. Issa M, Oesterling J: Transurethral needle ablation (TUNA): An overview of radiofrequency thermal therapy for the treatment of benign prostatic hyperplasia. Curr Opin Urol 6:20-27, 1996 2. Hecth P, Hayashi K, Cooley AJ, et al: The thermal effect of monopolar radiofrequency energy on the properties of joint capsule: An in vivo histologic study using a sheep model. Am J Sports Med 26:808-814, 1998
40
3. Chang KJ, Utley DS: Endoscopic ultrasound (EUS) in vivo assessment of radiofrequency (RF) energy delivery to the gastroesophageal (GE) junction in a porcine model. Gastrointest Endosc 53:165(abstr), 2001 4. Houston H, Khaitan L, Holzman M, et al: First year experience of patients undergoing the Stretta procedure. Surg Endosc 17:401-404, 2003 5. Takahashi T, Garcis-Osogobio S, Valdovinos MA, et al: Radio-frequency energy delivery to the anal canal for the treatment of fecal incontinence. Dis Colon Rectum 45:915-922, 2002 6. Takahashi T, Garcia-Osogobio S, Valdovinos MA, et al: Extended two year results of radio-frequency energy delivery for the treatment of fecal incontinence (the SECCA procedure). Dis Colon Rectum 46:711715, 2003 7. Efron JE, Corman ML, Fleshman J, et al: Safety and effectiveness of temperature-controlled radio-frequency energy delivery to the anal canal (SECCA procedure) for the treatment of fecal incontinence. Dis Colon Rectum 46:1606-1618, 2003
ELISA H. BIRNBAUM
Radiofrequency energy has been used for treatment of gastroesophageal reflux disease, benign prostatic hypertrophy, and joint laxity. The use of the SECCA procedure (submucosal delivery of radiofrequency energy to treat fecal incontinence) has been recently reported for fecal incontinence. Improvement in reported symptoms of fecal incontinence and quality has been reported. There has been no improvement in anal manometric findings in follow-up evaluations. No significant new defects have been noted on endo-anal ultrasound. The precise mechanism of action of radiofrequency energy in the treatment of fecal incontinence is unknown. Ongoing trials will help define the role for this technology. © 2004 Elsevier Inc. All rights reserved.
reatment of fecal incontinence is dependent on the severity and pathophysiology of the incontinence and should be approached in a step wise fashion First line therapy for mild incontinence is generally dietary alterations, antimotility medications, and pelvic floor exercises. More severe symptoms of fecal incontinence warrant a work-up to evaluate for neurogenic or mechanical injuries. Anal manometry, electromyography, and endo-rectal ultrasound are used to determine whether there is a defect in the internal or external anal sphincter and if the pudendal nerve terminal motor latency is abnormal. Patients with mechanical sphincter injuries are candidates for surgical repair. Anal sphincter reconstruction is performed if there is a defined injury to the external anal sphincter. Biofeedback has been used for second-line treatment for patients with fecal incontinence not amenable to surgical repair or in whom surgical repair has not been successful. Unfortunately, there are a large number of patients who have symptoms of fecal incontinence who have failed the first and second-line treatment options. There are limited additional options for patients with fecal incontinence in whom conservative therapy has failed. Radio frequency energy has been used to treat a variety of benign and malignant diseases in an effort to cause mechanical shrinkage and fibrosis.1-4 The radio-frequency energy heats tissue by means of water molecule friction. At temperatures greater than 65° C, collagen contraction and thus tissue shrinkage occurs. The remodeling of collagen reduces the wound volume over time. This has been shown to occur when radiofrequency energy is used in the treatment of benign prostatic hypertrophy1 and in lax joint capsules.2 Radio-frequency en-
T
From the Section Of Colon and Rectal Surgery, Washington University School of Medicine, St Louis, MO. Address reprint requests to Elisa H. Birnbaum, MD, Associate Professor of Surgery, Section Of Colon and Rectal Surgery, Washington University School Of Medicine, 660 South Euclid Ave, Box 8109, St. Louis, MO 63110. © 2004 Elsevier Inc. All rights reserved. 1096-2883/04/0601-0009$30.00/0 doi:10.1053/j.tgie.2004.02.001
38
ergy has been used in the treatment of gastroesophageal reflux disease (GERD) and has been shown to thicken the lower esophageal sphincter submucosa and circular layers.3 Quality of life scores are significantly improved and there is a decrease in the esophageal acid exposure time after treatment of patients with GERD. Although patients improved symptomatically, there were no significant changes in the mean lower esophageal sphincter pressures.4 Radio-frequency energy (SECCA procdure) was first used for fecal incontinence in 1999.5 This initial trial was a feasible study involving 10 patients and showed that radio-frequency energy could be delivered safely to the anal sphincter. Improvement in the Cleveland Clinic Florida scale for Fecal Incontinence and patient reported quality of life prompted further evaluation of this technique.
Technique The SECCA procedure can be done in the Ambulatory Center or Endoscopy Unit with intravenous sedation and local anesthesia. Patients are instructed to discontinue platelet-inhibiting medications 7 days prior to treatment to minimize bleeding from the treatment sites. A bowel-cleansing enema is given prior to the procedure and prophylactic antibiotics are given. The patient is placed in a prone jack-knife position and local anesthesia is given. The thickness of the rectal-vaginal septum is evaluated in female patients to determine the proximal extent of needle/lesion placement in the anterior quadrants. The radio frequency energy device (SECCA; Curron Medical, Sunnyvale, CA) is a clear plastic anoscopic barrel with a light cable for visualization (Fig 1). The device is positioned under direct visualizations so that the needles are aligned at the dentate line. The needle electrodes are deployed from within the anoscopic barrel (22 gauge, 7-mm length). Once deployed there is a reduction in the electrical impedance indicating electrode muscle contact. If a reduction in the impedance is not seen, the needles are redeployed to get improved contact with the sphincter. Thermo-couples (electrical thermometers) present within the tip and at the base of each needle monitor tissue and mucosal temperatures during the delivery of the radio-frequency energy and provide temperature feedback. A target temperature is preselected (85°centigrade) and the power is modulated to achieve this temperature. Continuous cooling of the mucosa is done via continuous outflow of cold water to the base of each needle to minimize surface mucosal ulceration. The generator delivers energy for 90 seconds. Once the energy is delivered, the needles are retracted and the instrument is advanced 0.5 cm proximal to the treatment site and the process is repeated. A total of four rings of treatment are produced between the dentate line and 15 mm proximal to the dentate line. In women with short sphincter length and thin rectal vaginal septum fewer lesions are placed in the anterior quadrants to minimize complications. The therapeutic
Techniques in Gastrointestinal Endoscopy, Vol 6, No 1 (January), 2004: pp 38-40
Fig 1. Radio-frequency energy delivery device (SECCA; Curron Medical, Sunnyvale, California) the clear barrel has a light for visualization. The circular black marking (arrow) shows the level from which needle electrodes are deployed. (Reprinted with permission.7)
goal is to create thermal lesions in the muscle while preserving mucosal integrity (Fig 2). The number of patients treated with this modality is limited; therefore. follow-up examination and evaluation as reported in the literature is limited.5-7 Reported complications have been minimal. Most of the complications are acute discomfort after the procedure and occasional minor bleeding. Superficial ulceration can occur if mucosal cooling is not optimized. Anal strictures have not been reported. One patient has developed an abscess in the rectovaginal septum that resulted in a significant rectovaginal fistula following a SECCA treatment (D. Beck, personal communication, December 2003). There appears to be no anatomic or physiologic change in the anal sphincter after treatment with radio-frequency energy. Anal manometry performed pre-treatment and six months post treatment did not show measurable differences in rest or squeeze pressures in patients who reported improved continence.6,7 Pudendal nerve terminal motor latency is not altered and there have been no additional findings of new defects or scar tissue when endo-anal ultrasound has been performed.6,7 Patient reported fecal incontinence symptoms and quality of life has been shown to be improved.5-7 In the initial study, by Takahashi et al, the median Cleveland Clinic Florida Fecal ENDOSCOPIC OPTIONS
Incontinence (CC-FI) score improved from 13.5 to 5 (P ⬍ .001) with 80% of patients considered responders at 12 months.5 A 2-year follow-up of the same patients showed that this improvement persisted.6Twenty-four months after the SECCA procedure the mean CC-FI score improved from 13.5 to 7.3 (P ⫽ .002) and eight patients had scores of less than or equal to 10. Similar improvements in patient reported fecal incontinence and quality of life were seen in a multicenter trial by Efron et al.7 The questionnaires were given at baseline and 6 months post-treatment. These authors found that although patient symptoms improved, the CC-FI scores did not show as dramatic an improvement (14.5 to 11.1 P ⬍ .0001) as reported in the earlier trials.5,6 The precise mechanism of action for the SECCA procedure has not been determined. The initial hypothesis was that the radio-frequency energy would result in a circumfential thermal lesion which would contract and “tighten” the internal anal sphincter. The hypothesis that this technique would improve resting and/or squeeze pressures has not been supported by initial data.6,7 Although symptomatic improvement has been documented, the exact population studied in these limited trials is a heterogeneous population with regards to fecal incontinence and mechanical anal sphincter defects.
39
Fig 2. Thermal lesions are delivered in four rings of treatments, beginning at the dentate line and moving approximately 5mm intervals. A total of 64 lesions are delivered in this way. (Reprinted with permission.6)
Many questions are still unanswered, including the mechanism of action and patient selection. Although on the surface it appears as if radio frequency energy may be a useful modality for treatment of fecal incontinence, further studies are warranted. A multicenter randomized controlled trial is currently underway.
References 1. Issa M, Oesterling J: Transurethral needle ablation (TUNA): An overview of radiofrequency thermal therapy for the treatment of benign prostatic hyperplasia. Curr Opin Urol 6:20-27, 1996 2. Hecth P, Hayashi K, Cooley AJ, et al: The thermal effect of monopolar radiofrequency energy on the properties of joint capsule: An in vivo histologic study using a sheep model. Am J Sports Med 26:808-814, 1998
40
3. Chang KJ, Utley DS: Endoscopic ultrasound (EUS) in vivo assessment of radiofrequency (RF) energy delivery to the gastroesophageal (GE) junction in a porcine model. Gastrointest Endosc 53:165(abstr), 2001 4. Houston H, Khaitan L, Holzman M, et al: First year experience of patients undergoing the Stretta procedure. Surg Endosc 17:401-404, 2003 5. Takahashi T, Garcis-Osogobio S, Valdovinos MA, et al: Radio-frequency energy delivery to the anal canal for the treatment of fecal incontinence. Dis Colon Rectum 45:915-922, 2002 6. Takahashi T, Garcia-Osogobio S, Valdovinos MA, et al: Extended two year results of radio-frequency energy delivery for the treatment of fecal incontinence (the SECCA procedure). Dis Colon Rectum 46:711715, 2003 7. Efron JE, Corman ML, Fleshman J, et al: Safety and effectiveness of temperature-controlled radio-frequency energy delivery to the anal canal (SECCA procedure) for the treatment of fecal incontinence. Dis Colon Rectum 46:1606-1618, 2003
ELISA H. BIRNBAUM