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nct MAJ Il y a 4 ans

A Randomized, Controlled, Clinical Trial of Biofeedback and Anal Injections as First Treatment of Fecal Incontinence A short presentation of a randomized clinical trial of biofeedback and anal injections as a first treatment option of faecal incontinence. Background: Faecal incontinence affects mainly women who have suffered sphincter disruption from vaginal delivery, but individuals of all ages can be affected. The treatment of this debility is not uniform between institutions or internationally. Often is surgical reconstruction of the anal sphincter performed, or other invasive, costly treatment options. The study: We intend to conduct a randomized, controlled, clinical trial where we compare the effect of two less invasive, less costly treatment options as a first alternative: biofeedback and anal injections. Our hypothesis is that anal injections will give a better and more lasting effect than biofeedback. The primary endpoint will be change in faecal incontinence assessed by the St. Marks incontinence score. Secondary endpoints will include change in quality of life and several physiological parameters. We intend to include 62 patients in both groups, 124 all together, from 2 centres in Norway. The observation time is 2 years. We plan to include the first patient April 2006, and conclude the study by December 2010. This study can contribute to a more appropriate treatment-algorithm for these patients. Study group: - Barthold Vonen MD PhD, Department of gastroenterological surgery, University Hospital of North Norway - Rolv-Ole Lindsetmo MD PhD, Department of gastroenterological surgery, University Hospital of North Norway - Arvid Stordahl MD PhD., Department of Surgery, Østfold Hospital Fredrikstad - Ylva Sahlin MD PhD, Department of Surgery, Innlandet Hospital Hamar - Trond Dehli, MD, Department of gastroenterological surgery, University Hospital of North Norway - Kjersti Mevik, Stud. Med, University of Tromso Project manager: Trond Dehli Funding, approvals, publication: This study is funded from Northern Norway Regional Health Authority and The Institution of Norwegian Health- and rehabilitation-organizations. It has been approved by the Regional Committee for Medical Research Ethics and Norwegian Social Science Data Services. The results will be published in an international peer-reviewed journal after the Vancouver-convention's guidelines. The results will also be presented at national and international conferences. Contact: Trond Dehli, Department of gastroenterological surgery, University hospital North Norway, Breivika, 9038 Tromsø [email protected] tlf: +47 776 26 000

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nct MAJ Il y a 4 ans

Postoperative Pain After Intravenous Vitamin C Injection for Arthroscopic Rotator Cuff Repair 1. Treatment of rotator cuff tear The rotator cuff tear is the most demanding part of the shoulder surgery. Rotator cuff degeneration is thought to be the largest cause of rotator cuff tear. As the field of shoulder surgery evolves, the diagnosis and surgical treatment of the rotator cuff tear was increased. Repair and reconstruction of the rotator cuff tear annually more than 300,000 have been performed according to US statistics. Rotator cuff repair is a successful procedure, both objectively and subjectively, with regard to pain relief and functional outcome. 2. postoperative pain management after rotator cuff repair Shoulder surgeries are associated with a level of postoperative pain requiring opioid use for several days. The opioid requirements after shoulder surgery have been reported to be similar to those required after gastrectomy or thoracotomy, which might cause several opioid-related side effects, such as nausea and vomiting, pruritus, urinary distention, and constipation. Although the introduction of arthroscopy has reduced postoperative pain, a considerable proportion of patients suffer from moderate to severe acute postoperative pain, as its benefit is typically apparent after a few days. Consequently, proactive pain control is also required during the first 24-48 h after arthroscopic shoulder surgeries, just like in open surgeries. Adequate pain management during the immediate postoperative period is not only important for patient satisfaction and well-being, but also for facilitating postoperative rehabilitation and preventing persistent postsurgical pain. Recently preoperative intravenous vitamin C has shown to increase the analgesic effect after otorhinolaryngologic surgery and thoracic surgery. Vitamin C is a water-soluble and known to have anti oxidant action, and fewer side effects. However, there is no report about the analgesic effect of vitamin C after arthroscopic rotator cuff repair. The purpose of this trial was to compare the effects of a intravenous vitamin C injection on postoperative pain and opioid consumption versus non-treated group after arthroscopic rotator cuff repair.

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