ACTRN12611000414910.
Study name | Bladder care following laparoscopy for benign non‐hysterectomy gynaecological conditions – a randomised controlled trial (ACTRN12611000414910) |
Methods | Study design: RCT |
Participants | Patients undergoing laparoscopic surgery for benign non‐hysterectomy gynaecological conditions Inclusion criteria: elective laparoscopy for a benign gynaecological condition; patients to be aged ≥ 18 years at time of surgery; patients who understand the conditions of the study and are willing to participate for the length of the prescribed term of follow‐up; patients who are capable of, and have given written informed consent to their participation in the study; patients presenting with benign gynaecological conditions that require surgical intervention as agreed to by the patient and her attending medical team Exclusion criteria: concurrent involvement in other research studies; past history of incontinence surgery; surgery for urinary incontinence or prolapse; suspected or confirmed gynaecological malignancy; patients scheduled for hysterectomy as part of their surgical procedure; patients with long‐term bladder catheterisation (intermittent or permanent); suspected or confirmed pregnancy at the time of surgery; intermittent flow pattern on uroflowmetry (indicative of pre‐existing voiding dysfunction); pre‐operative PVR ≥ 150 mL |
Interventions |
Group A: immediate removal of the IUC post‐laparoscopic surgery for benign non‐hysterectomy gynaecological conditions Group B: removal of the IUC at 6 am on the 1st post‐op day following laparoscopic surgery for benign non‐hysterectomy gynaecological conditions |
Outcomes | Incidence of post‐op UTI Incidence and pattern of post‐op voiding dysfunction PVR urine volume in patients before surgery Duration of hospital stay Re‐admission to hospital (incidence and indication) Unscheduled presentation to general practitioner Emergency department or outpatient service (clinic/rooms) Economic analyses of the 2 modalities for care |
Starting date | 1 March 2012 |
Contact information | Associate Professor Jason Abbott Royal Hospital for Women Barker Street Randwick NSW 2031 Country: Australia Phone: +61 2 93826111 Email: j.abbott@unsw.edu.au |
Notes | Recruitment status: not yet recruiting |