Rectus diastasis repair with and without mesh at 1 year: randomized clinical trial.

BACKGROUND: Rectus diastasis (RD) can cause functional impairment and pain. Surgical approaches vary regarding mesh use for linea alba restoration. The aim of this RCT was to compare plication supported by mesh (PSUM) with suture plication in patients with symptomatic postpartum RD. METHODS: This single-centre superiority double-blind RCT was conducted in Finland from April 2018 to November 2022. The pre-specified primary outcome was RD recurrence at 1 year (inter-rectus distance (IRD) >20 mm) and a post-hoc primary outcome was absolute reduction in IRD. Secondary outcomes included health-related quality of life (HRQoL), low back disability (Oswestry Disability Index (ODI)), motor control, and complications. The date of the last follow-up was 30 November 2022. RESULTS: In total, 86 normal-weight women (mean age of 38.7 (range 25-52) years) were randomized, with 84 patients (98%) available for follow-up (44 in the PSUM group and 40 in the suture plication group). At 1 year, there was no difference in RD recurrence between the PSUM group and the suture plication group (2 of 44 (5%) versus 2 of 40 (5%) respectively; P = 0.922). IRD reduction was greater in the PSUM group (52 (95% c.i. 48 to 56) mm) than in the suture plication group (44 (95% c.i. 40 to 47) mm) (P < 0.002). HRQoL, ODI, and enhanced performance test results all improved in both groups compared with baseline (P = 0.000-0.039). There was no difference in the complication rate between the PSUM group and the suture plication group (17 of 44 (39%) versus 13 of 40 (33%) respectively; P = 0.558). CONCLUSION: At 1 year, both PSUM and suture plication result in stable outcomes, with no difference in the RD recurrence rate, but the study was limited by both a small number of patients and a lower than anticipated overall RD recurrence rate. For the whole patient cohort, surgery was associated with improved motor control, low back function, and HRQoL compared with baseline. REGISTRATION NUMBER: NCT03509376 (http://www.clinicaltrials.gov).