Non‐randomized studies should be considered for assessing surgical techniques in rectal prolapse: prospective cohort study

Abstract

Aim Randomized trials comparing surgical techniques for rectal prolapse are not always feasible. We assessed whether non-randomized comparisons of those who have had surgery with those still waiting would be confounding baseline health status. Method This was a prospective cohort study in seven UK hospitals. Participants were ≥ 18 years and listed for surgical interventions of equivalent intensity for rectal prolapse. They were defined as short or long waiters (≤ 18 or > 18 weeks, respectively). Time on the waiting list was compared with baseline comorbidity (Charlson comorbidity index) and change from baseline in health status (EQ-5D-5L) at the time of surgery. Results In all, 203 patients were analysed. Median (interquartile range) waiting time was 13.7 weeks (8.1, 20.4) varying across sites. Baseline comorbidity was not an important predictor of waiting time. Median Charlson comorbidity index was 2 (0, 3) for short and 1 (0, 3) for long waiters. A change in waiting time by a week was associated with negligible improvement in the EQ-5D-5L index of 0.001 (95% CI −0.000 to 0.003, P = 0.106). Conclusion Negligible change in patient reported health status while on the waiting list and lack of effect of comorbidities in influencing waiting time support the use of non-randomized pre-/post-studies to compare the effects of surgical interventions for rectal prolapse.

Does Concomitant Pelvic Organ Prolapse Repair at the Time of Rectopexy Impact Rectal Prolapse Recurrence Rates? A Retrospective Review of the Prospectively Collected Pelvic Floor Disorders Consortium Quality Improvement Database Pilot

“…15 Many experts have gone as far as to conclude that the conduct of a definitively powered RCT that compares rectal prolapse surgical techniques may be simply impossible, despite best efforts by the colorectal community. [15][16][17][18] Variations in surgical techniques may be better and more effectively studied in these patients with realistic observational studies using an interrupted time series design or propensity score matching, for example. 17,18 The Pelvic Floor Disorders Consortium Rectal Prolapse Quality Improvement Data Collection Pilot database is a prospective cohort of rectal prolapse patients that was created because of this exact sentimentthat we need large-scale data to make meaningful conclusions as to the impact of surgical variability in techniques of rectal prolapse repairs on patient outcomes.…”