Extrait

Background and study aims The large intestine (colon) is part of the digestive system of the body. The partially digested food passes through the colon where water is extracted. In the colon defects such as polyps can be found. These abnormalities can be examined during a procedure which is called a colonoscopy. This is an examination of the colon with an endoscope. An endoscope is a flexible tube with a small lamp and camera at the tip. Through this tube the doctor can exchange tools to perform certain operations. However, in one of 1000-5000 patients who undergo a colonoscopy, a perforation or opening in the intestine may arise during the procedure. When a perforation of the intestinal wall occurs, it must be closed quickly so that the intestinal contents do not leak into the abdominal cavity, which can result in a life-threatening infection of the abdominal wall or a blood infection. A colon perforation following a colonoscopy is a rare condition. This makes it difficult to conduct research on the condition and its treatment. Because a perforation can cause a life-threatening infection of the abdominal wall or a blood infection, it is important to investigate whether the treatment can be improved. It might be possible to decrease the incidence of adverse events (complications) and to achieve a faster recovery after treatment. The current treatment for a perforation of the intestinal wall is a laparoscopic operation or open surgery performed by a surgeon in the operating room. For laparoscopy, the surgeon uses a special video camera, the laparoscope and other special instruments. The camera and instruments are inserted into the abdominal wall through 3-5 small incisions of 0.5 to 3 cm. The perforation is closed and the abdominal incisions are closed with hand sutures. This operation is always performed under general anaesthesia. In some cases it is not possible to do a laparoscopy and open surgery needs to be performed. For open surgery larger abdominal incisions are made to close the perforation. The incisions are sutured. After treatment the patient is admitted to the hospital. Sometimes, due to the perforation, the intestinal tissue surrounding the perforation is also affected and a part of the intestine needs to be removed. In some cases this may mean that a stoma should be made (an opening to the outside of the abdomen through which stool is collected in a bag). Recently a new endoscopic technique has been developed for the treatment of an intestinal perforation. For this new method a specially designed clip is used to immediately close the perforation during the procedure. An endoscopic bowel examination is performed under mild sedation, which means that the patient is less conscious. Using a special small grasper the edges on both sides of the perforation are pulled into the clip after which the clip closes the defect. By treating patients with this clip patients may recover faster and the chance of unfavourable side effects might be smaller compared to the standard surgical operation because no abdominal incisions need to be made. The aim of this study is to find out this new technique is as successful and safe as surgical closure, but with fewer side effects, improved appearance, and lower costs. Who can participate? Patients aged 18 years and older with an acute perforation of the colon that was caused during colonoscopy. What does the study involve? To compare the two treatments, the patient with a colon perforation will be randomly allocated to one of two groups. One group receives the standard treatment, which is to surgically close the intestinal perforation. In the other group, patients will be treated endoscopically with a clip to close the perforation. Colonoscopy is always done with mild sedation which means that an anaesthetic and analgesic is administered through a drip in your hand. With this medication your consciousness is reduced. Therefore we cannot ask you if you want to participate in the study. It is important to treat the perforation as soon as possible. This means that you do not have sufficient time to decide whether you want to participate. Because the new treatment shows good results in earlier studies with patients, we think that you will be well treated with both techniques. We have therefore chosen to randomly allocate the treatment immediately after we knew a perforation was made and you will know after you wake up from the sedation what way you were treated. Because we are interested in your general health, we will ask you to complete two short questionnaires. What are the possible benefits and risks of participation? If you are treated with the standard surgical treatment it means that you have no additional advantages that could be a consequence of your participation in the study. For this standard treatment it means that no additional risks are expected for you than those known for this standard treatment: the risk of bleeding during or after surgery and the risk of an infection of the abdomen or the surgical wounds. If you are treated with the endoscopic clip there is a small chance that it is not possible to adequately close the perforation with the new clip. If this occurs the gastroenterologist can decide to treat the perforation with the standard surgical procedure. It is also possible that the bowel contents may leak into the abdominal cavity prior to closure of the perforation. This can mean that an abdominal infection can develop. Regarding these problems it can mean that you have to stay in hospital longer than expected or that additional treatment or procedures have to take place. Because you do not have surgical wounds you could experience less pain after treatment. It can also mean that you can sooner return to your normal daily activities. Additionally, you have less chance to develop infections of the abdominal wounds and because of absence of abdominal incisions you will not have abdominal scars. Where is the study run from? It is being organised by Academic Medical Center, University of Amsterdam in Amsterdam. Several centers are participating, including: 1. Cliniques Universitaires Saint-Luc, Brussels, Belgium 2. Erasme University Hospital, Brussels, Belgium 3. Universitätsklinikum Hamburg-Eppendorf, Hamburg, Germany 4. Medizinische Klinik, Evangelisches Krankenhaus Düsseldorf, Germany 5. GastroZentrum Hirslanden Zürich, Switzerland 6. Universitätsspital Zürich, Switserland 7. Catholic University of Rome, Italy 8. Erasmus Medical Centre Rotterdam, the Netherlands 9. St. Antonius Hospital, Nieuwegein, the Netherlands 10. Catharina Hospital Eindhoven, the Netherlands: 11. Sint Lucas Andreas ziekenhuis, Amsterdam, Netherlands 12. Onze Lieve Vrouwe Gasthuis hospital, Amsterdam, the Netherlands 13. University Medical Centre Utrecht, the Netherlands 14. University Medical Centre Groningen, Groningen, the Netherlands 15. Academical hospital Maastricht, Maastricht, the Netherlands 16. Flevoziekenhuis, Almere, the Netherlands When is the study starting and how long is it expected to run for? The study will start in January 2012 and will run until January 2015. Who is funding the study? The study is an investigator-initiated study. When possible, Ovesco (Tuebingen, Germany) will provide the Over-The-Scope-Clip and associated materials. Who is the main contact? Tessa Verlaan (PhD student) [email protected]

Critère d'inclusion

• Acute colonic perforation

Liens

• isrctn
• ictrp