Stepped-wedge randomized controlled trial of laparoscopic ventral mesh rectopexy in adults with chronic constipation (2021)

Type of publication:
Conference abstract

Grossi U.; *Lacy-Colson J.; Brown S.; Cross S.; Eldridge S.; Scott S.M.; Taheri S.; Knowles C.

Colorectal Disease. Conference: 16th Scientific and Annual Meeting of the European Society of Coloproctology, ESCP 2021. Virtual. 23(Supplement 2) (pp 3), 2021. Date of Publication: October 2021.

Aim: Effectiveness of laparoscopic ventral mesh rectopexy (LVMR) in patients with defecatory disorders secondary to internal rectal prolapse (IRP) is poorly evidenced. A UK-based multicentre randomized controlled trial (RCT) was designed to determine the clinical efficacy of LVMR compared to controls at medium-term follow-up. Method(s): A stepped-wedge RCT design permitted observer-masked data comparisons between patients awaiting LVMR with those who had undergone surgery.Adult participants with radiologically confirmed IRP refractory to conservative treatment were randomized to 3 arms with different delays before surgery. Efficacy outcome data were collected at equally stepped time points (12, 24, 36, 48, 60, and 72 weeks). Clinical efficacy of LVMR compared to controls was measured as a 1.0-point reduction in PAC-QOL and PAC-SYM scores at 24 weeks. Secondary outcome measures included 14-day diary data, GAD7, PHQ9, St Marks incontinence score, PISQ12, CC-BRQ, and BIPQ. Result(s): Of 42 eligible patients, 28 (67%) females were randomized from 6 institutions. Nine were assigned to the T0 arm, 10 to T12, and 9 to T24. There were no substantial differences in baseline characteristics between the 3 arms. Compared to baseline, significant reduction in PAC-QOL and PAC-SYM scores were observed at 24 weeks post-surgery (-1.09 [95%CI -1.76, -0.41], P = 0.0019, and -0.92 [-1.52, -0.32], P = 0.0029). As opposed to PAC-QOL (-1.38 [-2.94, 0.19], P = 0.0840 at 72 weeks), improvements in PAC-SYM scores persisted to 72 weeks (-1.51 [-2.87, -0.16], P = 0.0289). Compared to baseline, no differences were found on secondary outcomes, except for significant improvements on CC-BRQ and BIPQ at 24 and 48 weeks. Conclusion(s): There was evidence of a short-term effect of LVMR for IRP up to 36 weeks. Improvements in quality of life declined over follow-up up to 72 weeks.

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