Extrait

Background and study aims Hemorrhoids, or piles, are swellings containing enlarged blood vessels found inside or around the anus and rectum. Most piles are mild and do not cause any problems, but symptoms include bright red blood found after passing a stool, an itchy anus and a viable lump hanging down from the anus. Many cases go away on their own or can be treated by lifestyle changes or medications. Surgical treatment can be recommended, however, if other treatments do not work or are not suitable. A hemorrhoidectomy involves cutting out the hemorrhoids under general anaesthetic. A stapled haemorrhoidopexy involves stapling the last section of the large intestine (anorectum), which reduces the supply of blood to the haemorrhoids and causes them to gradually shrink. There are a number of different hemorrhoidectomy and haemorrhoidopexy techniques. Recent studies have compared the open and closed hemorrhoidectomy techniques with each other and to Longo’s hemorrhoidopexy technique, but no study has compared this new procedure with Parks’ hemorrhoidectomy or analysed all three of these surgical procedures. In this study, we aim to compare all of these surgical treatments to determine whether Longo’s technique is painless and associated with an earlier return to work. Who can participate? Patients with symptomatic hemorrhoids requiring surgical treatment who have not had a similar surgical procedure before. What does the study involve? The patients are randomly allocated to one of three groups. Those in group 1 undergo stapled rectal mucosectomy performed according to Longo’s surgical technique. Those in group 2 undergo open hemorrhoidectomy performed according to Milligan-Morgan’s technique. Those in group 3 undergo closed hemorrhoidectomy performed according to Park’s technique. All patients are operated on under general anaesthesia. All patients report on their experience of pain (according to VAS scale) in a home diary every morning before taking pain medications. All patients are followed by a single proctological specialist for the first week, including a rectal digital exploration, and then at two weeks, and at one, three and four months, including endoscopic examination. Finally, patients are contacted by telephone interview with an ambulatory visit in case of recurrence or other late complications. What are the possible benefits and risks of participating? There are no benefits or risks for the participants. Where is the study run from? Università Campus Bio-Medico di Roma, Rome (Italy) When is the study starting and how long is it expected to run for? April 1998 to January 2007 Who is funding the study? Investigator initiated and funded (Italy) Who is the main contact? Dr Valter Ripetti [email protected]

Critère d'inclusion

• Symptomatic hemorrhoids who were deemed to require surgical treatment

Liens

• ictrp
• isrctn