Extrait

Background and study aims Haemorrhoids, also known as piles, are swellings containing enlarged blood vessels that are found inside or around the bottom (the rectum and anus). Surgery to remove haemorrhoids (haemorrhoidectomy) often leads to pain and discomfort in the period after the operation. Injection of methylene blue, a biological dye, around the anus (perianal) has been shown anecdotally to cause less pain. Methylene blue has also been used successfully in patients with severe itch around the anus who failed to improve with medication. Excellent results have been reported in an earlier study of patients undergoing lateral sphincterotomy (a procedure to treat anal fissures). The aim of this study is to assess the effectiveness of methylene blue injection on pain after haemorrhoidectomy. Who can participate? Patients aged between 21 and 80 with haemorrhoids What does the study involve? Participants are randomly allocated to be treated with either methylene blue and marcaine (an anesthetic), or marcaine only. After the operation participants are asked to fill in a pain diary and to attend the standard routine reviews in the outpatient clinics. Participation in the study lasts 6 weeks, which is the usual follow-up period for a haemorrhoidectomy patient. Participants need to visit the doctor’s office two times in the course of the study at 2 weeks and 6 weeks after the procedure for assessment of their wounds. These visits are part of routine assessment after surgery. What are the possible benefits and risks of participating? There is no expected benefit from participation in this study. However, participation in this study may add to the medical knowledge about the use of methylene blue on pain after haemorrhoidectomy. Methylene blue, being a biological dye, will cause temporary discoloration of the skin and urine. Very rarely, perianal infections may occur. Allergic reactions can occur with any drug. Common symptoms include rash and itch. To date, no severe or life-threatening allergic reaction has occurred with methylene blue. Symptoms of a severe reaction include: swelling of the face, difficulty breathing, and a sudden drop in blood pressure that may cause dizziness. Even though methylene blue is commonly used, participants may experience other side effects that have not yet been reported. Where is the study run from? Khoo Teck Puat Hospital (Singapore) When is the study starting and how long is it expected to run for? August 2008 to January 2012 Who is funding the study? Investigator initiated and funded (Singapore) Who is the main contact? Dr Tan Kok Yang

Critère d'inclusion

• Symptomatic 3rd and 4th degree haemorrhoids

Liens

• ictrp
• isrctn