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

Objectives

Randomised trials comparing surgical techniques for rectal prolapse are not always feasible. We assessed whether non‐randomised comparisons of those who have had surgery with those still waiting would be confounded baseline health status.

Study Design and Setting

Prospective cohort study in seven UK hospitals. Participants ≥18 years listed for surgical interventions of equivalent intensity for rectal prolapse. Participants were defined as short or long waiters (≤ or >18 weeks, respectively). Time on the waiting list was compared with baseline comorbidity (Charlson Comorbidity Index, CCI) and change from baseline in health status (EQ‐5D‐5L) at the time of surgery.

Results

203 patients were analysed. Median (IQR) waiting time was 13.7 weeks (8.1, 20.4) varying across sites. Baseline comorbidity was not an important predictor of waiting time. Median CCI 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 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 waiting list and lack of effect of comorbidities in influencing waiting time supports the use of non‐randomised pre‐/post‐study to compare the effects of surgical interventions for rectal prolapse.