PROSPER: a randomised comparison of surgical treatments for rectal prolapse
Autor: | Richard Gray, N. C. Armitage, J. Harding, J M A Northover, Robert Kerrin Hills, Lee J Middleton, Asha Senapati, Laura Buckley |
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Jazyk: | angličtina |
Rok vydání: | 2016 |
Předmět: |
Adult
Male medicine.medical_specialty Perineum Resection law.invention Quality of life Randomized controlled trial Recurrence law Humans Medicine Bowel function Resection rectopexy Digestive System Surgical Procedures Aged Proportional Hazards Models Aged 80 and over Surgical approach business.industry Suture Techniques Hazard ratio Rectum Gastroenterology Rectal Prolapse Middle Aged medicine.disease Surgery Rectal prolapse Treatment Outcome Quality of Life Female business Fecal Incontinence |
Popis: | Aim Rectal prolapse is a profoundly disabling condition, occurring mainly in elderly and parous women. There is no accepted standard surgical treatment, with previous studies limited in methodological quality and size. PROSPER aimed to address these deficiencies by comparing the relative merits of different procedures. Method In a pragmatic, factorial (2 × 2) design trial, patients could be randomised between abdominal and perineal surgery (i), and suture vs resection rectopexy for those receiving an abdominal procedure (ii) or Altemeier's vs Delorme's for those receiving a perineal procedure (iii). Primary outcome measures were recurrence of the prolapse, incontinence, bowel function and quality of life scores (Vaizey, bowel thermometer and EQ-5D) measured up to 3 years. Results Two hundred and ninety-three patients were recruited: 49 were randomised between surgical approaches (i); 78 between abdominal procedures (ii); and 213 between perineal procedures (iii). Recurrence rates were higher than anticipated, but not significantly different in any comparison: Altemeier's vs Delorme's 24/102 (24%) and 31/99 (31%) [hazard ratio (HR) 0.81; 95% CI 0.47, 1.38; P = 0.4]; resection vs suture rectopexy 4/32 (13%) and 9/35 (26%) (HR 0.45; 95% CI 0.14, 1.46; P = 0.2); perineal vs abdominal 5/25 (20%) and 5/19 (26%) (HR 0.83; 95% CI 0.24, 2.86; P = 0.8). Vaizey, bowel thermometer and EQ-5D scores were not significantly different in any of the comparisons. Conclusion No significant differences were seen in any of the randomised comparisons, although substantial improvements from baseline in quality of life were noted following all procedures. |
Databáze: | OpenAIRE |
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