Technology and Products

Numerous diseases in the gastrointestinal tract require surgical procedures in which parts of the intestine are resected (cut off) and joined together again. One such disease is cancer in the large intestine. A majority of all colorectal cancers are treated by surgery. Colorectal cancer surgery is always time consuming and, if the anastomosis needs to be formed in the lower pelvic area, it is also very difficult for the surgeon to get sufficient access for suturing the intestine together. One third of these cases, so-called low resections, are in the lower pelvic area where surgeons need to anastomose the colon to the rectum. The anatomical difficulties have brought forward new procedures. More than half a century ago (1964) the circular stapling instrument was introduced. This was the start of a new era in the possibilities of anastomosing the colon to the rectum. The circular stapling instrument has been refined and improved since its introduction but the basic principles for the instrument remain. The use of the circular stapler for anastomosis after low resections has been the established surgical procedure for the last 45 years. Although the stapling technique is a common procedure it is associated with certain problems.

  • Some studies claim that up to 30% of patients undergoing surgery for rectal cancer suffer from leakage in the anastomosis.
  • The staplers can cause significant narrowing of the lumen which causes intestinal stenosis and consequently inconveniences for the patient.
  • When Anastomotic leakage occurs after surgery it is difficult to detect and consequently it is a substantial doctors delay in recognition of the diagnosis.

The most severe problem of the stapling technique is of course anastomotic leakage. As a consequence, many clinicians routinely create a protective stoma proximal to the anastomosis. This stoma may be temporary or permanent depending on the condition of the patient. Anyhow, this forces the patient not only to endure a stoma for a certain period of time but also requires a reoperation when the stoma is put down again. This implies a new anastomosis with a renewed risk for leakage. Furthermore, convincing data shows that radiotherapy before surgery will decrease local reoccurrence and increase the 5-year survival, but radiotherapy also makes the remaining tissue more vulnerable and less supportive to healing. It is highly understandably that the majority of patients want to avoid a permanent stoma and a majority of patients prefer radiotherapy before surgery. To implement these requirements most developed markets start the treatment of rectal cancer patients with radiotherapy 6-8 weeks before surgery and during surgery use staplers to create an anastomosis and a temporary protective stoma at the level of the small intestine in order to reduce the risk of anastomotic leakage. Due to this established method 80-90% of all low rectal cancer patients will get a temporary stoma. In spite of this precaution with a stoma around 10% of the patients with a stapled anastomosis will develop a leakage and require additional treatment on the ward or the intensive care unit. Moreover, most of the patients with a temporary stoma will undergo surgery again within 2-4 months in order to close the stoma.

The table below shows that to conduct a permanent stoma is the most safe way, since you avoid all risky parts of the operation. But nobody wants to end up with a permanent stoma if there is an option. Today the option is stapled technique even if it is a risky affair. Our goal is of course to give the patients the same opportunity but with substantially reduced risks.

Severe leakage is of course the most expensive drawback in all aspects and it is also associated with a high degree of mortality which is not possible to compensate. To put a relieving (temporary) stoma during the primary operation is also associated with high costs. Increased surgical time, stoma material costs for 3 months and a second operation to close the stoma. The stricture in the anastomosis is an underestimated cost. Most patient use stool softener the rest of their life and a few patients (5%) will come back to the hospital to dilatate the stricture and in some severe cases experience a new operation with a permanent stoma as a solution for a long standing problem.