Holes in the surgical seam are a frequent and serious complication in patients who have undergone surgery in the intestines. Researchers have developed a 3D printed implant that can help these patients.

2020.06.25 | Helle Horskjær Hansen/Marianne Lie Becker

The implant is made of polycaprolactone, which has already been approved for use as an implant. It is suitable for all the special stapling machines currently available on the market for surgical equipment. Photo: Marianne Lie Becker.

After surgery in which part of the intestines is removed and the remainder is reconnected, holes may occur in the surgical seam. These holes are known as an anastomotic leakage and are a fairly frequent and serious complication.

In up to one in ten cases, the stapling used to make the surgical seam does not hold up, meaning that the patient may have to live with a stoma for the rest of their life. Patients also have a generally reduced quality of life, higher mortality rates and the risk of relapses of their cancer.

Researchers from Aarhus University and the University of Southern Denmark have now developed a small 3D printed implant that may help the approximately 1,500 people who annually undergo intestinal surgery in which the ends are stapled together using a method known as stapled anastomose.

Solves a real problem 

The small implant is placed between the two ends of the intestine before these are stapled together.

"The idea arose after other tests on sealing the seams, because we so often face the issue of them not holding up. We therefore contacted Dang Quang Svend Le at Aarhus University, who is an expert in biomedical 3D printing," says Mark Ellebæk.

He is a surgeon and clinical associate professor at the University of Southern Denmark and Odense University Hospital, where he primarily works with intestinal surgery, most often as a result of colorectal cancer.

The design and form of the new implant builds on already available knowledge about intestinal anatomy and physiology, including the muscular movements of the intestines.

From the outset, Dang Svend Le, who is an engineer and assistant professor, has focused on producing a simple implant that would fit seamlessly into the existing tools used in intestinal surgery.

Surgeon priorities

"In the field of implant research, we often see there is focus on very grandiose solutions that experiment with stem cells, gene therapy, growth factors, nanotechnology and so on. Instead, this implant was designed on the basis of a list of priorities drawn-up by surgeons at the hospital. This has paid off in the form of an implant that first and foremost works, is easy to work with and is uncomplicated to produce and sterilise," says Dang Svend Le.

The researchers have tested the method with the 3D implant on pigs, and the first experiments have shown positive results.

Pigs have been chosen as laboratory animals because they resemble humans so closely that the results can in all probability be transferred to humans.

But first, the next round of experiments with the method must be carried out. In these, the researchers will test the implant in the surgical procedure which is carried out in connection with colorectal cancer. Here the operation takes place via an endoscope through the stomach and a stapler which is led into the rectum.

"In the first instance, we’ve shown that the stapling holds twenty per cent better when we use the implant. The first experiment was carried out on the small intestine, which is easier to reach. Now we will test it on the rectum. If the results are just as good, then we won’t be so far away from testing the implant on humans," says Mark Ellebæk on the perspectives for the implant.

Background for the results 

• The study is an animal study carried out on pigs. The researchers have tested the durability of the stapling in the intestine after five days.
• The study was carried out in collaboration with the Department of Clinical Medicine, Aarhus University and two elite medical students at the University of Southern Denmark, Kasper Daugaard Larsen and Marc Westerholt.
• Read the scientific article about the use of the implant which has been published in Langenbeck’s Archives of Surgery

Contact

Dang Quang Svend Le
Aarhus University, Department of Biomedicine
dqsl@clin.au.dk