PROSPER: a randomised comparison of surgical treatments for rectal prolapse

• Published in: Colorectal disease Vol. 15; no. 7; pp. 858 - 868
• Main Authors: Senapati, A., Gray, R. G., Middleton, L. J., Harding, J., Hills, R. K., Armitage, N. C. M., Buckley, L., Northover, J. M. A.
• Format: Journal Article
• Language: English
• Published: England Blackwell Publishing Ltd 01.07.2013
• Subjects: Adult; Aged; Aged, 80 and over; Digestive System Surgical Procedures - methods; factorial design; Fecal Incontinence - etiology; Fecal Incontinence - surgery; Female; Humans; Male; Middle Aged; Perineum - surgery; Proportional Hazards Models; PROSPER; Quality of Life; randomised controlled trial; Rectal prolapse; Rectal Prolapse - complications; Rectal Prolapse - surgery; Rectum - surgery; Recurrence; surgery; Suture Techniques; Treatment Outcome; factorial design; Rectal prolapse; randomised controlled trial; PROSPER; surgery
• ISSN: 1462-8910; 1463-1318
• DOI: 10.1111/codi.12177

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.