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Table 1 The VUE RCTs: two parallel RCTs evaluating the surgical options for upper compartment pelvic organ prolapse

From: How to deal with a temporary suspension and restarting your trial: our experiences and lessons learnt

The VUE RCTs [9, 10] Design and comparisons Condition No. of participants recruited at the time of suspension Mesh in use within the trial Implications of suspension
Uterine trial Vaginal hysterectomy compared to uterine suspension Uterine prolapse 224 Uterine suspension procedure dependant on the surgeon’s normal practice (as such, patients may have no mesh, abdominal mesh* or transvaginal mesh) Recruitment
Temporary suspension in Scottish sites only (suspending recruitment of new participants and randomisation of consented participants). No change to the rest of the UK.
Intervention
Sites advised to follow local NHS governance on the use of TV synthetic mesh for participants awaiting surgery. This may have deviated from the randomised intervention.
Follow-up
Continued as per protocol
Vault trial Abdominal vault suspension compared to a vaginal vault suspension Vault prolapse 87 Abdominal procedure requires the use of abdominal mesh*; vaginal vault procedure dependant on the surgeon’s normal practice (as such, patients may have no mesh or may have transvaginal mesh)
  1. *Abdominal mesh was not included in the requested suspension