Ostomy

Implantica’s Solution, StomaRestore®

Implantica’s StomaRestore® is subject to further development and approval process. StomaRestore® is designed to free patients who need an ostomy operation or existing ostomates from using stoma bags, which will greatly improve their quality of life. Many patients need to remove part of their intestine due to illness and therefore receive a stoma, which is when the end of the intestine protrudes through the abdominal wall. These patients use a plastic bag to collect their fecal matter outside the abdominal wall. StomaRestore® is expected to offer a completely new solution to those patients and is expected to permanently free patients from using stoma bags.

StomaRestore® is expected to permanently free patients with a stomy from using stoma bags.

StomaRestore® is designed to be controlled wirelessly or by a push button under the skin and to use an artificial sphincter and electrical stimulation in such a way that is expected to mimic the bowel organs’ natural function.

StomaRestore® is designed to offer a sphincter function and to control the emptying of a reservoir made from the intestines. The reservoir prolongs the time in between bowel emptying. A muscle contraction of the intestinal wall causes emptying of the reservoir at patient’s will. StomaRestore® is designed to use a combination of hydraulic pressure and electrical stimulation to help control the flow of liquids and food passing through the intestine.

Benefits of StomaRestore®

Freedom from stoma bags

StomaRestore® is designed to avoid plastic stoma bags outside the abdominal wall for the collection of fecal matter, which should significantly increase patients’ quality of life and may provide them with a permanent freedom from the constraints of having to wear and regularly change the plastic bag.

Remote-control will provide independence

When using the remote control or push button under the skin, the patient has the potential to decide when to release fecal matter for defecation.

Adaptable intelligent pressure to prevent damage to the bowel

The closing pressure of StomaRestore® is designed to vary in position, which should allow for optimal blood circulation and permit time for recovery.

The reservoir will be placed inside the body

A reservoir will be created using the intestine itself. The device is designed to empty the reservoir using natural muscle wall contractions applying electrical stimulation.

Field Description

Ostomy surgery is a treatment method for severe intestinal disease in the abdomen. It is also the end alternative when all other treatment methods fail for fecal incontinence. An ostomy is a surgically created opening of the intestines and the abdominal wall through which waste material passes out of the body from the bowel (or urinary tract). A stoma is the end of the bowel, protruding through the abdominal wall. After ostomy surgery, patients need to wear a stoma bag for collection of bodily waste often for the rest of their lives.

Different types of ostomy procedures are performed depending on how much and what part of the intestine is removed. Colostomy refers to a surgical procedure where a portion of the large intestine is brought through the abdominal wall to carry stool out of the body, meanwhile an ileostomy refers to the small intestine, brought through the abdominal wall and in this case collecting floating fecal matter. In both cases patients must wear a plastic stoma bag over the stoma to collect all waste. Sometimes the intestine can be operated back into the abdomen, however, often it’s a permanent solution.

The end of the ileum, which is the lowest part of the small intestine, is brought through the abdominal wall to form a stoma due to illness or lack of the large intestine called colon. A plastic stoma bag is usually attached to the abdominal wall to collect waste matter, which is liquid when it reaches the ileum. An ileostomy may be temporary or permanent and when permanent often involve removal of a part of or the complete colon.

Existing Treatments

The causes for needing ostomy surgery include chronic disease in the intestine such as inflammatory bowel disease (mainly Morbus Crohn and Ulcerous colitis), intra-abdominal infection, injury to the colon or rectum, colon/rectal cancer or wounds or fistulas.

People of all ages are affected and whether the ostomy is temporary or permanent depends on the specific disease or injury. Ostomy surgery severely impacts quality of life and can significantly affect the patient’s self-image. Additional problems associated with ostomy include leakage from the stoma, allergic reaction and food blockages, leakage of mucous and bleeding from anus or prolapse.

Detailed Treatment Field Information

An ostomy involves creating a stoma, an artificial opening on the abdominal wall, through which waste material passes out of the body from the bowel (or urinary tract). Patients need to wear a stoma bag for collection of bodily waste, often for the rest of their lives.

The terms ostomy and stoma are often used interchangeably, although they have different meanings: An ostomy refers to the surgical procedure to create an opening in the body, while a stoma is the end of the bowel, protruding through the abdominal wall.

Ostomy surgery is a treatment method for severe abdominal disease, which we will describe from different angels in the following sections.

^{Fig. 4}

Description and definition

Different types of ostomy procedures are performed depending on how much, and what part, of the intestines is removed. The operation may involve a colostomy, removing a part of the large intestine, or an ileostomy, removing a part of the small intestine.

Colostomy refers to a surgical procedure where a portion of the large intestine is brought through the abdominal wall to carry stool out of the body. Patients who have had a colostomy need to wear an appliance (stoma bag) over the stoma to collect all waste until the colon can be operated back into the abdomen. In some cases, the colostomy is a permanent solution.

An ileostomy is an opening created in the small intestine to bypass the colon for stool elimination. The end of the ileum, which is the lowest part of the small intestine, is brought through the abdominal wall to form a stoma. A stoma appliance is normally attached to the abdominal wall to collect waste matter, which is liquid when it reaches the ileum. However, one type of ileostomy, called Kock’s pouch, may not require such an appliance.

Causes and effects

The causes for having an ostomy may be chronic disease in the intestine, intra-abdominal infection, injury to the colon or rectum, colon/rectal cancer, or wounds or fistulas. People of all ages are affected. Whether the ostomy is temporary or permanent depends on the specific disease or injury.

Since colostomy and ileostomy bypass the sphincter muscle, there is no voluntary control over bowel movements and an external pouch must be worn to catch the discharge. Obviously, these operations severely influence the quality of life and have an impact on the patient’s self-image. Other problems may be leakage (from the stoma), allergic reaction, and food blockages, leakage of mucous and bleeding from the rectum, or even prolapse.

Colorectal cancer

Cancer of the large intestine (colon) and rectum (last 6 inches of the colon) is referred to as colorectal cancer. Early signs of cancer may include changes in bowel habits and passing blood or mucus with the feces, tiredness and loss of weight, and pain or a lump in the abdomen. Colorectal cancer affects about 1.2 million people worldwide (Garcia et. al, 2007). If detected in an early stage, about 90% of colorectal cancers can be cured through surgery (National Cancer Institute, 2008).

The exact causes of colorectal cancer are not known, but certain factors are linked to an increased chance of developing cancer, e.g: age over 50, polyps in the colon or rectum, familial adenomatous polyposis (a rare kind of polyps), inherited genetic abnormalities, and

inflammatory bowel diseases. Some evidence suggests that the development of colorectal cancer may be associated with a diet that is high in fat and calories and low in fibre. Moreover, research suggests that a sedentary lifestyle may be associated with an increased risk. In contrast, people who exercise regularly may have a decreased risk of developing colorectal cancer. People who are obese, have diabetes and insulin resistance may also have an increased risk of this type of cancer (Colon Cancer Alliance, 2008).

Inflammatory bowel disease (IBD)

Inflammatory bowel disease (IBD) includes a number of chronic inflammatory disorders, leading to damage of the gastrointestinal tract, whereof the two most common are Chrohn’s disease and Ulcerative colitis. Crohn’s disease is a chronic inflammation of the intestines, usually confined to the terminal portion of the small intestine (ileum). It is most common during the ages 20 to 30.

Ulcerative colitis is a similar, and more common, condition that causes inflammation and sores (ulcers) in the lining of the large intestine (colon). Around 25-30% of the patients with ulcerative colitis are considered for surgery if medication is not effective (Crohn’s and Colitis Foundation of America, 2008).

As mentioned, these, and other inflammatory bowel diseases, have been associated with a higher risk of colorectal cancer. Patients who have had extensive ulcerative colitis for many years are at an increased risk of developing large bowel cancer (National Cancer Institute, 2008).

Existing treatments

Both colorectal cancer and IBD can ultimately lead to an ostomy surgery for the patient but is much more frequent for cancer than for IBD. However, the surgical procedure is essentially the same for both types of diseases. Here, we describe the procedure for a colorectal cancer patient, thus not very different from a procedure for an IBD patient destined for surgery.

The first treatment for colorectal cancer is usually surgery. If the primary tumour could be removed and the cancer has not spread (metastasised), the patient has a good chance of survival. Chemotherapy using various combinations of drugs and biological agents can shrink tumours, reduce symptoms, and extend survival time. Other treatment options that directly seek to destroy cancer tissues, such as radiofrequency ablation, are also choices for some cases of advanced colorectal cancer (National Cancer Institute, 2008).

Diagnosis of colon cancer is performed by examinations of the colon. The following methods can be used:

• Sigmoidoscopy. A flexible tube passed into the rectum and lower part of the large bowel.
• Colonoscopy. A method of looking inside the entire bowel through a flexible tube passed via the rectum.
• Barium enema. An x-ray of the large bowel after a barium mixture has been passed into the rectum.

Traditionally, colon cancers are removed through open laparotomy with partial colectomy bowel resection. A more recent method is laparoscopic-assisted colectomy (commonly known as keyhole surgery), where smaller incisions are made to insert special surgical instruments into the abdomen. This requires special training, takes longer than open laparotomy, and is more expensive. Advantages are shortened hospital recovery time and reduced need for pain medication after surgery (Chung, 2007). Surgical treatment of rectal cancer requires special preparation and techniques as the rectum is located deep in the pelvis and affects the anal sphincter. Large tumours are very difficult to remove completely without injuring the anal sphincter resulting in faecal incontinence.

There are mainly two types of ostomy operations described hereafter.

Colostomy

Colostomy is the surgical procedure to attach a portion of the colon to an abdominal opening to allow faecal matter to exit. In colostomy the opening is from the colon, parts of the rectum may be removed and the colon is attached to a stoma. Sigmoid or descending colostomy is the most common type of ostomy surgery, in which the end of the descending or sigmoid colon is brought to the surface of the abdomen, usually located on the lower left side.

Patients who have had a colostomy have no voluntary muscular control over the bowel movement. It is therefore necessary to wear an adhesive drainage bag; or stoma appliance, around the stoma to collect all waste until the colon can heal or additional corrective surgery can be performed. In some cases, if the rectum has been damaged and/or removed, the colostomy is a permanent solution.

A colostomy is often performed by open surgery with a two weeks stay in hospital and six months recovery period due to the large incision. However, keyhole surgery takes less time and is performed through two tiny incisions. Patients spend around four days in hospital and because of the few small wounds patients heal much faster and can be back to normal in a matter of weeks (American Cancer Society, 2008a).

Advantages with a colostomy are that it can cure the underlying disease, has known long-term results, is a relatively simple surgery, and bring fewest complications. Disadvantages are that this method requires an external pouching system that needs to be emptied 4-6 times daily. Occasional problems can be prolapse, narrowing, retraction and skin problems.

Ileostomy

Ileostomy is a surgical procedure in which the lowest part of the small intestine (ileum) is attached to the abdominal wall. Digestive waste then exits the body through a stoma located on the abdominal wall. A stoma appliance is normally attached to the abdominal wall to collect faecal matter.

An ileostomy may be temporary or permanent, and involve removal of a part, or all, of the colon. Since the late 1970s, an alternative to ileostomy has been the ileoanal reservoir (Kock’s pouch) where an internal reservoir is formed, using the ileum, to collect waste matter. The ileum is connected to the anus, after removal of the colon and rectum, avoiding the need for an external stoma appliance.

Other types are so-called J- or S-shaped reservoirs. However, because faecal matter from the small intestine is liquid, it is difficult to maintain continence. All these methods involve problems such as frequent toilet visits and a high incidence of perianal skin problems. To be a candidate for this type of surgery, the patient needs an intact anal sphincter, which is rarely the case (American Cancer Society, 2008b).

Socio-economic burden

The socio economic burden of faecal incontinence (FI) and ostomy surgery is substantial. A major problem for patients suffering from FI is the high risk of infection, which prolongs the hospital stay and need for after care. If treated, these patients can enhance their quality of life and become able to return to work. Resources can be released and used within other areas of society, and the cost for medical care can be reduced.

Examples of cost areas are:

• Tied up resources in the health sector and in society as a whole.
• Decreased, or non-existent, productivity affecting the overall economy.
• Financial burden on family, friends and society welfare.

FI has a dramatic impact on the health care system, as existing treatments are often complicated and associated with high costs. The cost of today’s commercially available artificial sphincters ranges from USD 6 400 to 16 000. This can be can be compared to the long-term cost of treatment of FI secondary to childbirth injury, estimated at more than USD 17 000 per patient (Person & Wexner, 2005).

Items with the strongest impact on the overall cost of FI are: incontinence material (diapers, pants, nappies, anal tampons, waterproof sheets, faeces bags etc.), which accounts for a large part of total expenditures. For instance in the US, FI accounts for more than USD 400 million per year for adult diapers only (Kalantar, Howell & Talley, 2002). In addition, it is the second leading cause of admission to long-term facilities in the US (Person & Wexner, 2005).

Furthermore, a large proportion of direct as well as indirect health care costs involved with FI, derive from the cleaning of incontinent patients. It has been estimated that personnel in charge of caring for incontinent patients who are permanently in institutions, devote more than 13% of time available to this duty. However, the cost of health care personnel is not limited only to time and salary. Staff members who spend much of their time cleaning incontinent patients are more prone to dissatisfaction, depression and infection than are those engaged in other activities, and they are more likely to give up their jobs. (Ratto, Ponzi, Di Stasi & Parello, 2007)

Implantica is developing products with the aim to offer more effective treatments, facilitating for surgeons and patients and thereby reducing costs for hospitalization, medication and after care.

Field conclusion

The final treatment for severe FI is ostomy surgery in order to create a stoma to enable defecation. This has significant impact on a patient’s quality of life and can severely limit their social life. The methods of avoiding a stoma and connecting the small intestine to the anus still have too many problems to be an attractive method for most patients. These methods are used because no better option is at hand. Implantica is developing an outstanding solution for patients who need, or have had, ostomy surgery with products that are designed to permanently free patients from using ostomy bags. Implantica’s new device is designed to be placed around the intestine to enable the patient to control when to empty the bowel; an alternative to stoma bags, this solution is designed to enable patients to live a normal life with physical exercise and intimacy.