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eDigest, Winter 2013

Finding More Effective Treatments For Fecal Incontinence

Three new treatments for fecal incontinence are now available, thanks to Cleveland Clinic colorectal surgeons, whose leadership in clinical trials helped these therapies gain acceptance and U.S. FDA approval. As a result, they are among the most experienced surgeons in the world with these treatments and are able to provide the most appropriate procedure for each individual.

The three options – two of which are office-based procedures – are a welcome addition to anal sphincter repair, the sole option available until now. These new treatments – sacral nerve stimulation, injectable therapy and radiofrequency treatment – approach fecal incontinence from different directions.

Having three new approaches allows the surgeon to individualize treatment for this frustrating and embarrassing condition based on the underlying reason for the fecal incontinence.

“Fecal incontinence doesn't cause mortality, but it does cause heartache. Although we have experience with overlapping sphincter repair, our 10-year data showed that the positive effects of this treatment simply don’t last. We needed other treatments, and now we have more options,” says Cleveland Clinic colorectal surgeon Tracy Hull, MD, Section Head of Pelvic Floor Disorders, who participated in clinical trials of all three new techniques with her colleague, Cleveland Clinic Florida Colorectal Surgery Chairman Steven Wexner, MD.

Sacral nerve stimulation

Sacral nerve stimulation is a technique developed and used in Europe since 1994 to treat both urinary and fecal incontinence. It was approved for use by urologists in the United States in 1997. Dr. Wexner was lead investigator in North America for the study that led to FDA approval of Medtronic’s InterStim device in 2011 (Ann Surg. 2010;251(3):441-449). Five-year results were recently published by Drs. Hull, Wexner and their co-investigators (Dis Colon Rectum. 2013;56(2):234-245).

The technique is performed in two stages. First, an electrode is implanted in the spine against the third sacral nerve. When an electrical current is applied to the sacral nerves that supply the pelvis, the brain perceives an improvement in sensation. Unlike other treatments, this may cause both sensory and motor improvements.

After two weeks of observation, if the patient achieves a 50 percent improvement in their overall fecal incontinence as measured by the Wexner Incontinence Score, a permanent pulse generator is implanted.

Cleveland Clinic colorectal surgeons have among the largest experience in the world with this procedure for fecal incontinence, which Dr. Wexner says has a low complication rate and a good reputation.

“When it works – which it does in 75 to 85 percent of the time – the patient gains motor and sensory improvement. If there is no improvement, nothing is lost, and we can try one of the other new techniques,” says Dr. Wexner.

Injectable therapy

Several injectable products are in development, but only one – Solesta by Salix Pharmaceuticals – has been approved in the U.S. Solesta is made from the naturally occurring compounds dextranomer and hyaluronic acid and is designed to create bulk in a selected area of the anal canal.

“Like sacral nerve stimulation, the exact mechanism of action is unclear, but it does improve fecal control, perhaps through bulk in the anal canal region,” says Dr. Hull.

The injection can be performed in the office and is well tolerated. No anesthesia is needed.

The initial study to obtain FDA approval included patients with severe and moderate fecal incontinence. The optimal patient population for this treatment is still being investigated. The procedure has a 55 to 60 percent success rate (Lancet. 2011;377(9770):997-1003), with sustained results at three years (Dis Colon Rectum, January 2013.)

Radiofrequency treatment

Radiofrequency therapy is the oldest of the three treatments for fecal incontinence. Originally developed by an otolaryngologist for the endoscopic treatment of gastroesophageal reflux disease (for which it is called Stretta), Secca therapy was approved for fecal incontinence in 2002. However, the procedure did not gain popularity until it was purchased, refined and released by Mederi in 2010.

Secca therapy is an outpatient procedure in which electrodes are applied to the submucosa of the rectum and radiofrequency energy is delivered for 60 seconds. It is theorized that this energy causes collagen re-formation, improving sensation in anywhere from 37 to 80 percent of patients (Dis Colon Rectum, 2010;53:1041-1046).

Five-year studies have shown that improvement endures over time. The procedure is performed in an endoscopy suite or outpatient operating room with local anesthesia or conscious sedation.

Determining the most appropriate patient population for this procedure – as well as the others – is a work in progress.

“We need more work to determine where these treatments stand,” says Dr. Hull. “There are always going to be some patients on whom a treatment is not going to work. The good thing is that we have other good treatment options to fall back on.”

Improving sphincter repair

Meanwhile, efforts continue to improve anal sphincter repair in order to make the procedure viable for a larger population. Cleveland Clinic colorectal surgeon Massarat Zutshi, MD, is the principal investigator of an animal trial that involves the use of stem cells and a cytokine product incorporated in an engineered scaffold. The study, which will begin this year, is a result of preliminary studies done in her laboratory. “This is the next step. We are trying to grow new, functioning tissue to cover a larger gap resulting from injury,” she explains.

Co-investigators include Anthony Calabro Jr, PhD, a Cleveland Clinic biomedical engineer who holds the patent for one of the scaffolds, and Marc Penn, MD, PhD, from Summa Health in Akron, Ohio. The project is funded by an $800,000 grant to be given over five years by the Department of Defense, which is interested in its potential for treating wounded veterans with pelvic floor injuries. “We have an eye on translation. Hopefully, this will become an option for treating fecal incontinence in the future,” says Dr. Zutshi.

Dr. Wexner is a consultant for Medtronic, Salix and Mederi. Drs. Hull and Zutshi have no relevant or material financial interests that relate to the research described above.

Cleveland Clinic to Bring First Online CME to China

Cleveland Clinic and Peking Union Medical College Hospital (PUMCH), China’s premier medical center, are in the final stages of forming an education consortium. Prior to the consortium, China only offered live CMEs. The advent of online programming with Cleveland Clinic will give Chinese physicians much-improved access to medical education.

“The online CMEs will reinforce and enhance clinical knowledge of global advances in the field, foster problem solving and collaboration, and improve practice behaviors and quality of patient care, ” says William D. Carey, MD, Director, Center for Continuing Education, Cleveland Clinic. “The programs will also provide a forum for enhancing the medical/scientific English-speaking skills of the Chinese medical community.”

In addition, the consortium’s bi-lingual website will include high-caliber, accreditation-quality postgraduate programs that will reach the country’s 2.4 million physicians, fulfilling a growing need for medical education in China.The first phase of the website will offer CMEs for hepatology (especially viral hepatitis) and gastroenterology, and rheumatic and immunologic disease.

“The consortium is focused on bringing medical education to China and sharing our knowledge and expertise in specialized areas of healthcare,” says Beth Christoff, Education Manager for the Digestive Disease and Surgery Institute.

While China’s medical technology capabilities are significantly advanced, the need for medical education through CME opportunities in China is growing considerably. Health Minister Chen Zhu has set a goal of 9 million fully trained providers by 2015 and 12 million by 2020. Minister Zhu says the CME effort is critical to reach this capacity.

The consortium anticipates launching CMEs in China within the first quarter of 2013 with a long-term goal to produce programs in many specialties for Chinese practitioners – cardiology, diabetes mellitus and wellness, among others. PUMCH and Cleveland Clinic will work together to develop content for the programs.

“There is great potential for continuing to expand programming in China,” Dr. Carey says. “This is the beginning of a mutually beneficial, long-term partnership.”

Physicians from the Peking Union Medical College Hospital and Cleveland Clinic will collaborate to create online CMEs for the consortium. The educational planning committee members for the hepatology/gastroenterology CME program include:

  • William D. Carey, MD, Director, Center for Continuing Education, Cleveland Clinic
  • Dian-Jung Chiang, MD, Staff, Department of Gastroenterology and Hepatology, Cleveland Clinic
  • Yue Li, MD, Staff Gastroenterologist, Peking Union Medical College Hospital
  • Jiaming Qian, MD, Chair, Professor of Medicine, Peking Union Medical College Hospital
  • Bo Shen, MD, FACG, Section Head and Professor of Medicine, Department of Gastroenterology and Hepatology, Cleveland Clinic
  • Anthony Tavill, MD, Professor of Medicine, Case Western Reserve University

New Section of Surgical Oncology to Improve Outcomes and Promote Innovative Care

“Working in collaboration with colleagues from Taussig Cancer Institute and across Cleveland Clinic, we offer the ability to treat some of the more advanced malignancies, such as retroperitoneal sarcomas and advanced-stage melanomas,” explains Dr. Grobmyer, who joined Cleveland Clinic in September 2012 as Director, Section of Surgical Oncology, Department of General Surgery. A major focus is on multidisciplinary care of the cancer patient – collaborating with colleagues from medical oncology, radiation oncology and radiology. “The best treatment is evolving,” he says. “Cancer treatment often involves surgery, radiation and medical therapy. We are working together to determine what the optimal combinations of treatments and their timing will be for each patient.”

Examples of innovative treatments already being offered include:

  • Minimally invasive and robotic surgery options for gastrointestinal malignancies
  • Treating advanced malignancies with regional chemotherapy
  • Using the Nanoknife® IRe system as an alternative treatment for pancreatic cancers
  • Utilizing hyperthermic intraperitoneal chemotherapy (HIPEC) for tumors of the appendix, colon, stomach and ovary, as well as peritoneal mesothelioma
  • New catheter-based techniques for administering radiation therapy to patients with retroperitoneal sarcomas
  • Single-dose intraoperative radiation therapy for breast cancer
  • Nipple-sparing mastectomy for breast cancer

Other areas of emphasis will include enrolling patients in clinical trials, expanding the role of genetics in how treatments are selected, and continuing to improve the experience of the cancer patient — from early diagnosis through treatment and recovery.

“This new section will enrich our ability to further provide the highest quality of care for patients with solid tumors,” he says. “It also sets the platform for us to continue to bring innovative treatments in areas such as pancreatic cancers and others where much overall progress has yet to be made toward improving outcomes.”

Digestive Disease Clinical Trials

Highlights of our featured clinical trials in both Cleveland and Florida:

IRB 11-1092
Disease: Celiac Disease
A Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Different Doses of Larazotide Acetate for the Treatment of Celiac Disease.

Summary: For patients diagnosed with Celiac Disease who have been following a gluten free diet for at least 1 year and are actively experiencing symptoms of Celiac Disease. The purpose of this study is to look at the effectiveness and safety of three different doses of Larazotide Acetate. Patients will continue to follow their current diet and will receive study medication or placebo for up to 147 days. There will be 7 visits for tests and procedures and 1 follow-up telephone visit. Patients will be given a small hand-held electronic device to record daily and weekly diary information.

IRB 12-549
Disease: Celiac Disease
Clinical Evaluation of Three Celiac Disease-Specific Patient Reported Outcome Instruments in Established and Newly Diagnosed Celiac Disease Patients.

Summary: Two types of patients with celiac disease will be enrolled in this study: newly diagnosed, and those who have been diagnosed with celiac disease who have been on a gluten-free diet for at least 12 months. Patients will complete 5 surveys by telephone and internet to answer questions about your symptoms and how the gluten-free diet affects your life.

IRB 13-022
Disease: Crohn's Disease
A Phase II study to evaluate the efficacy and safety of 12 weeks of treatment with oral CNDO 201 Trichuris Suis Ova Suspension (TSO) as compared to placebo, followed by a 12 week open-label treatment period in patients with moderately to severely active Crohn's Disease.

IRB 9285
Disease: Crohn's Disease
A Non-Interventional Long-term Post-Marketing Registry of Patients treated with Certolizumab Pegol (Cimzia®) for Crohn's Disease.

IRB 12-071
Disease: Laparoscopic Left Colectomy
The PILLAR II (Perfusion In Laparoscopic Left colectomy/ Anterior Resection) Multi-Center Trial

IRB 12-072
Disease: Fecal Incontinence
A Prospective, Single Arm, Multicenter, Observational Assessment of the Long Term Safety and Efficacy of Solesta® Injectable Bulking Agent for the Treatment of Fecal Incontinence (SoFI)

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